WHOPIR Archive Page

After a period of three years, WHOPIRs are moved to the section marked "Archived WHOPIRs".

If a site is inspected and found to be non-compliant with GMP after a WHOPIR was issued following a previous inspection, that WHOPIR will be removed from the website (as the site can no longer considered compliant with GMP).

WHOPIRs Archive by Category

The World Health Organization Public Inspection Reports (WHOPIRs) below are listed for information only. The WHO Prequalification Team: medicines can be contacted (prequalinspection@who.int) at for copies.

Stream

Category

Inspection Dates

Title

VCP

10/10 Textile Joint Stock Company

12 November, 2018 - 16 November, 2018

Hanoi,

Viet Nam

VCP

A to Z Textile Mills Limited

13 June, 2018 - 14 June, 2018

Arusha,

United Republic of Tanzania

IVD

Abbott GmbH & Co KG - Desk Assessment

2 December, 2019

Wiesbaden,

Germany

IVD

Abbott Molecular Inc - Desk Assessment

19 September, 2019

Des Plaines, Illinois,

United States of America

Accutest Research Lab (I) Pvt Ltd

10 December, 2013 - 13 December, 2013

Ahmedabad,

India

Accutest Research Laboratories (I) Pvt Ltd

16 January, 2019 - 18 January, 2019

Vadodara,

India

Accutest Research Laboratories (I) Pvt Ltd (Unit I)

19 February, 2018 - 23 February, 2018

Navi Mumbai,

India

Accutest Research Laboratories (I) Pvt Ltd (Unit-I)

25 September, 2017 - 29 September, 2017

Ahmedabad,

India

Accutest Research Laboratories (I) Pvt Ltd (Unit-I)

26 September, 2011 - 27 September, 2011

Navi Mumbai,

India

Accutest Research Laboratories Pvt Ltd

15 May, 2012 - 18 May, 2012

Navi Mumbai,

India

ACDIMA BioCenter for Bioequivalence and Pharmaceutical Studies

21 September, 2016 - 23 September, 2016

Amman,

Jordan

Acebright (India) Pharma Pvt Ltd

23 February, 2015 - 26 February, 2015

Karnataka,

India

Acebright (India) Pharma Pvt Ltd

21 January, 2013 - 24 January, 2013

Bangalore,

India

Acme Formulation Pvt Ltd

17 January, 2018 - 19 January, 2018

Himachal Pradesh,

India

ACME Foundation Pvt Ltd

11 August, 2015 - 14 August, 2015

Himachal Pradesh,

India

Adcock Ingram Ltd

18 April, 2011 - 20 April, 2011

Johannesburg,

South Africa

Adcock Ingram RD&I

8 December, 2016 - 9 December, 2016

Gauteng,

South Africa

Agila Specialties Private Limited, Sterile Products Division

16 August, 2011 - 19 August, 2011

Banglore,

India

Aizant Drug Research Solutions Pvt Ltd

23 March, 2015 - 25 March, 2015

Hyderabad,

India

Aizant Drug Research Solutions Pvt Ltd

20 October, 2011 - 21 October, 2011

Hyderabad,

India

Ajanta Pharma Limited

17 June, 2013 - 20 June, 2013

Aurangabad,

India

Ajanta Pharma Limited - Desk Assessment

10 June, 2020

Gujarat,

India

Ajanta Pharma Ltd, Paithan

27 June, 2011 - 30 June, 2011

Aurangabad,

India

Alivira Animal Health Limited - Desk Assessment

26 July, 2019 - 29 July, 2019

Visakhapatnam,

India

Alkem Laboratories Ltd

17 August, 2015 - 20 August, 2015

Daman,

India

Altasciences - Desk Review

20 December, 2018 - 21 December, 2018

Quebec,

Canada

Amsal Chem Pvt Ltd

21 November, 2018 - 23 November, 2018

Ankleshwar,

India

AnaCipher Clinical Research Organization - Desk Review

29 January, 2020

Hyderabad,

India

AndersonBrecon (UK) Ltd - Desk Assessment

27 May, 2020 - 28 May, 2020

Hereford,

United Kingdom of Great Britain and Northern Ireland

Andhra Organics Ltd

21 May, 2019 - 24 May, 2019

Andhra Pradesh,

India

Anhui Biochem Bio-Pharmaceutical Co Ltd

22 July, 2019 - 26 July, 2019

Heifei City,

China

Anhui Biochem Bio-pharmaceutical Co Ltd

15 August, 2016 - 18 August, 2016

Anhui,

China

Anhui Biochem United Pharmaceutical Co Ltd

15 July, 2019 - 19 July, 2019

Anhui,

China

Anhui Biochem United Pharmaceutical Co Ltd

19 January, 2016 - 22 January, 2016

Anhui,

China

APTYS PHARMASERVICES

8 October, 2018 - 9 October, 2018

Saint Beauzire,

France

Arwan Pharmaceutical Industries

9 July, 2019 - 12 July, 2019

Mount Lebanon,

Lebanon

Aspen Port Elizabeth (Pty) Ltd

17 April, 2013 - 19 April, 2013

Port Elizabeth,

South Africa

Aspen Port Elizabeth (Pty) Ltd

8 March, 2010 - 11 March, 2010

Republic of,

South Africa

Aspen SVP Pty (Ltd)

22 April, 2013 - 26 April, 2013

Port Elizabeth,

South Africa

Aurisco Pharmaceutical Co Ltd

25 October, 2019 - 28 October, 2019

Zhejiang Province,

China

Aurisco Pharmaceutical Ltd

29 January, 2018 - 1 February, 2018

Tiantai,

China

AXIS Clinicals Ltd

18 December, 2017 - 21 December, 2017

Hyderabad,

India

Azidus Laboratories Ltd

13 November, 2017 - 17 November, 2017

Chennai,

India

BA Research India Ltd

18 October, 2010 - 20 October, 2010

Ahmedabad,

India

Bayer de México S.A. de C.V.

23 April, 2013 - 26 April, 2013

Veracruz,

Mexico

VCP

Bazhou Jintong Textile Processing Factory

9 May, 2019

Bazhou city,

China

BB-NCIPD Ltd

11 March, 2020 - 13 March, 2020

Sofia,

Bulgaria

BB-NCIPD Ltd

18 April, 2016 - 22 April, 2016

Sofia,

Bulgaria

Beijing Bio-Institute Biological Products Co Ltd (BBIBP)

6 March, 2017 - 10 March, 2017

Beijing,

China

Beijing Novartis Pharma Co Ltd

24 June, 2014 - 26 June, 2014

Beijing,

China

Beijing Novartis Pharma Ltd

26 September, 2011 - 29 September, 2011

Beijing,

China

Beximco Pharmaceutical Limited

10 March, 2020 - 12 March, 2020

Gazipur,

Bangladesh

Beximco Pharmaceutical Ltd

7 February, 2017 - 10 February, 2017

Dhaka,

Bangladesh

Bharat Biotech International Limited (BBIL)

4 September, 2017 - 8 September, 2017

Telangana,

India

Bharat Biotech International Ltd (BBIL), Telangana, India (27 February - 03 March 2017)

27 February, 2017 - 3 March, 2017

Telangana,

India

Bio Pharma Services Inc (BPSI) - Desk Review

7 November, 2018

Ontario,

Canada

Biochemical and Synthetic Products Pvt Ltd

17 February, 2015 - 20 February, 2015

Telangana,

India

Biological E. Limited

4 February, 2019 - 8 February, 2019

Telangana,

India

Biological E. Limited

3 October, 2016 - 7 October, 2016

Hyderabad,

India

Bioserve Clinical Research (P) Ltd

19 May, 2010

Hyderabad,

India

Bombay Bioresearch Centre (BBRC

18 July, 2011 - 20 July, 2011

Mumbai,

India

Bombay Bioresearch Centre (BBRC)

18 May, 2011 - 20 May, 2011

Mumbai,

India

Bombay Bioresearch Centre (BBRC)

11 October, 2010 - 15 October, 2010

Mumbai,

India

Bureau of Drug and Narcotic, Ministry of Public Health (BDN)

3 November, 2014 - 4 November, 2014

Muang Nonthaburi,

Thailand

Bureau of Drug and Narcotic, Ministry of Public Health (BDN)

30 April, 2012 - 2 May, 2012

Nonthaburi,

Thailand

Bureau of Drugs and Narcotics (BDN), Ministry of Public Health

16 September, 2019 - 18 September, 2019

Muang Nonthaburi,

Thailand

CAD Middle East Pharmaceutical Industries LLC

2 May, 2017 - 5 May, 2017

Riyadh,

Saudi Arabia

Cadila Pharmaceuticals Ltd

25 March, 2019 - 27 March, 2019

Ahmedabad,

India

Cadila Pharmaceuticals Ltd

9 June, 2014 - 13 June, 2014

Ahmedabad,

India

Cadila Pharmaceuticals Ltd

16 December, 2013 - 19 December, 2013

Ahmedabad,

India

Cadila Pharmaceuticals Ltd

26 November, 2012 - 29 November, 2012

Ankleshwar,

India

Cadila Pharmaceuticals Ltd

11 April, 2011 - 14 April, 2011

Ahmedabad,

India

Cadila Pharmaceuticals Ltd

6 December, 2010 - 7 December, 2010

Ahmedabad,

India

Cadila Pharmaceuticals Ltd - Unit I

21 April, 2015 - 24 April, 2015

Ankleshwar,

India

Calyx Chemicals & Pharmaceuticals Limited

13 June, 2011 - 16 June, 2011

Tarapur,

India

Calyx Chemicals & Pharmaceuticals Ltd

28 January, 2019 - 1 February, 2019

Tarapur,

India

Calyx Chemicals & Pharmaceuticals Ltd

22 June, 2015 - 24 June, 2015

Tarapur,

India

Canton Laboratories Pvt Ltd

18 July, 2016 - 20 July, 2016

Vadodara,

India

Central Laboratory for Quality Control of Medicines and Medical Products (CLQCM)

17 February, 2020 - 20 February, 2020

Kyiv,

Ukraine

Central Laboratory for Quality Control of Medicines and Medical Products SE, State Drug Administration

4 February, 2013 - 5 February, 2013

Kyiv,

Ukraine

Centro Nacional de Control de Calidad (CNCC)

7 August, 2013 - 9 August, 2013

Lima,

Peru

Centro Nacional de Control de Calidad (CNCC)

7 August, 2013 - 9 August, 2013

Lima,

Peru

Centro Nacional de Control de Calidad/National Center for Quality Control (CNCC)

25 March, 2010 - 26 March, 2010

Lima,

Peru

Changzhou Yabang - QH Pharmachem Co Ltd

20 May, 2019 - 23 May, 2019

Changzhou city,

China

Changzhou Yabang-QH Pharmachem Co Ltd

4 July, 2016 - 7 July, 2016

Jiangsu,

China

Changzhou Yabang-QH Pharmachem Co Ltd

16 September, 2013 - 18 September, 2013

Jiangsu Province,

China

IVD

Chembio Diagnostics Malaysia Sdn. Bhd.

29 July, 2019 - 31 July, 2019

Selangor,

Indonesia

Chengdu Institute of Biological Products Co Ltd

9 April, 2018 - 13 April, 2018

Chengdu,

China

Chengdu Institute of Biological Products Co Ltd (CDIBP)

23 May, 2016 - 27 May, 2016

Sichuan Province,

China

CHI Pharmaceuticals Ltd

8 May, 2014 - 10 May, 2014

Osgodi,

Nigeria

China Resources Zizhu (CRZ) Pharmaceutical Co Ltd

22 October, 2018 - 26 October, 2018

Beijing,

China

China Resources Zizhu Pharmaceutical Co Ltd

25 January, 2016 - 28 January, 2016

Beijing,

China

China Resources Zizhu Pharmaceutical Co Ltd

21 January, 2014 - 24 January, 2014

Beijing,

China

Chongqing Holley Wuling Mountain Pharmaceutical Co Ltd

6 March, 2018 - 9 March, 2018

Chongqing,

China

Chongqing Holley Wuling Mountain Pharmaceutical Co Ltd

8 December, 2014 - 11 December, 2014

Chongqing,

China

Chongqing Holley Wullingshan Pharmaceutical Co, Ltd

24 November, 2010 - 26 November, 2010

Chongqing,

China

Chongqing Kangle Pharmaceutical Co Ltd - Desk Review

3 October, 2018

Chongqing,

China

Chromo Laboratories India Pvt Ltd - Desk Review

17 September, 2019

Patancheru,

India

Cipla Ltd

15 April, 2019 - 19 April, 2019

Kurkumbh,

India

Cipla Ltd

19 January, 2018 - 25 January, 2018

Patalganga,

India

Cipla Ltd

15 January, 2018 - 18 January, 2018

Patalganga,

India

Cipla Ltd

20 June, 2016 - 22 June, 2016

Himachal Pradesh,

India

CIPLA Ltd

18 March, 2014 - 21 March, 2014

Bangalore,

India

CIPLA Ltd

17 February, 2014 - 20 February, 2014

Patalganga,

India

CIPLA Ltd

10 February, 2014 - 14 February, 2014

Patalganga,

India

CIPLA Ltd

18 November, 2013 - 20 November, 2013

Mumbai,

India

CIPLA Ltd

17 October, 2011 - 20 October, 2011

Indore,

India

CIPLA Ltd

27 June, 2011 - 30 June, 2011

Bangalore,

India

CIPLA Ltd

21 February, 2011 - 24 February, 2011

Patalganga,

India

CIPLA Ltd

14 February, 2011 - 17 February, 2011

Goa,

India

CIPLA Ltd

10 February, 2011 - 12 February, 2011

Kurkumbh,

India

CIPLA Ltd

16 August, 2010 - 19 August, 2010

Indore,

India

CIPLA Ltd

9 August, 2010 - 12 August, 2010

Patalganga,

India

Cipla Ltd - Desk Assessment

15 June, 2020

Pithampur,

India

Cipla Ltd - Desk Assessment

8 May, 2020 - 12 May, 2020

Bangalore,

India

Cipla Ltd - Indore

3 October, 2017 - 6 October, 2017

Pithampur,

India

Cipla Ltd - Unit 1 - Desk Assessment

1 May, 2020 - 3 May, 2020

Himachal Pradesh,

India

CIPLA Ltd - Unit 8

21 September, 2011 - 24 September, 2011

Goa,

India

CIPLA Ltd - Unit I & II

14 February, 2011 - 17 February, 2011

Patalganga,

India

CIPLA Ltd - Unit I, II and III

19 August, 2014 - 22 August, 2014

Kurkumbh,

India

CIPLA Ltd - Unit I, III, IV and VII

27 November, 2013 - 29 November, 2013

Goa,

India

Cipla Ltd - Unit I, Unit-II, Unit-III

8 April, 2019 - 12 April, 2019

Kurkumbh,

India

Cipla Ltd - Unit II, Unit IV, Unit VII, Unit VII PDII, Unit VIII

18 March, 2019 - 23 March, 2019

Goa,

India

CIPLA Ltd - Unit IX

6 September, 2010 - 9 September, 2010

Goa,

India

Cipla Ltd - Unit-III, IV, VII and PD-II

13 June, 2016 - 17 June, 2016

Salcette,

India

Cipla Ltd - Unit-IX

6 June, 2016 - 10 June, 2016

Salcette,

India

Cipla Ltd - Unit-VIII

13 June, 2016 - 17 June, 2016

Salcette,

India

CIPLA Ltd - Units III, IV and VII

6 September, 2010 - 9 September, 2010

, Goa,

India

CIPLA Ltd, Baddi

27 February, 2012 - 29 February, 2012

Himachal Pradesh,

India

CIPLA Ltd, Pharma I & II

21 November, 2011 - 24 November, 2011

Kurkumbh,

India

Cipla Ltd, Unit I

7 March, 2016 - 15 March, 2016

Kurkumbh,

India

CIPLA Ltd, Unit I & IV

13 October, 2014 - 16 October, 2014

Pithampur,

India

Cipla Ltd, Unit I, II & III

7 March, 2016 - 15 March, 2016

Kurkumbh,

India

Cipla Ltd, Unit IX

21 November, 2013 - 26 November, 2013

Goa,

India

Cipla Quality Chemical Industries Limited

3 November, 2015 - 6 November, 2015

Kampala,

Uganda

Cipla Quality Chemical Industries Ltd

12 June, 2019 - 18 June, 2019

Kampala,

Uganda

CKD BIO Corporation

3 December, 2012 - 6 December, 2012

Ansan-City,

Republic of Korea

Cliantha (previously BA Research India Ltd)

19 June, 2012 - 22 June, 2012

Ahmedabad,

India

Cliantha Research Limited

25 June, 2018 - 29 June, 2018

Ahmedabad,

India

Cliantha Research Ltd

19 March, 2013 - 22 March, 2013

Gujarat,

India

Clinical Diagnostic Centre of National University of Pharmacy (NUPh CDC)

12 March, 2018 - 16 March, 2018

Kharkov,

Ukraine

Comisión de Control Analítico y Ampliación de Cobertura (CCAYAC)

19 April, 2013 - 22 April, 2013

Tlalpan,

Mexico

Comisión para el Control de Calidad de Medicamentos (CCCM)

19 August, 2013 - 21 August, 2013

Montevideo,

Uruguay

Comisión para el Control de Calidad de Medicamentos/Drug Quality Control Commission (CCCM)

18 March, 2010 - 20 March, 2010

Montevideo,

Uruguay

CSPC Ouyi Pharmaceutical Co Ltd

13 July, 2015 - 17 July, 2015

Hebei,

China

Dean Superior Textile Co Ltd

25 October, 2018 - 26 October, 2018

Jianxi,

China

VCP

Dean Superior Textile Co Ltd

25 October, 2018 - 26 October, 2018

Jiangxi,

China

VCP

Decotex Co Ltd

6 February, 2020 - 7 February, 2020

Long An Province,

Viet Nam

Delta Finochem Pvt Ltd

11 September, 2017 - 13 September, 2017

Tal-Igatpuri,

India

IVD

Diagnostics for the Real World Ltd

21 November, 2019 - 22 November, 2019

United States of America

Dong-A Pharmaceutical Co Ltd

1 December, 2011 - 2 December, 2011

Gyeonggi-do,

Republic of Korea

Dong-A Pharmaceutical Co Ltd

28 November, 2011 - 30 November, 2011

Cheonan City,

Republic of Korea

Dong-A ST Co Ltd

27 May, 2013 - 28 May, 2013

Gyeonggi-do,

Republic of Korea

Dong-A ST Co Ltd

22 May, 2013 - 24 May, 2013

Cheonan City,

Republic of Korea

Dong-A ST Co Ltd (Cheaon-An Plant)

14 November, 2016 - 17 November, 2016

Cheonan City,

Republic of Korea

Drugs Testing Laboratory Faisalabad (DTLF)

23 September, 2019 - 25 September, 2019

Faisalabad,

Pakistan

Egyptian International Pharmaceutical Industries Company (EIPICO)

6 May, 2019 - 9 May, 2019

Ramadan City,

Egypt

Eisai Pharmatechnology and Manufacturing Pvt Ltd

21 January, 2013 - 24 January, 2013

Parawada,

India

Emcure Pharmaceuticals Ltd

8 March, 2010 - 11 March, 2010

Pune,

India

EuBiologics Co Ltd

24 August, 2015 - 28 August, 2015

Gangwon-do,

Republic of Korea

European Egyptian Pharmaceutical Industries (EEPI) Co

19 November, 2012 - 22 November, 2012

Alexandria,

Egypt

European Egyptian Pharmaceutical Industries Company (EEPI)

8 May, 2017 - 11 May, 2017

Alexandria,

Egypt

Evans Medical Plc

5 May, 2014 - 7 May, 2014

Agbara,

Nigeria

Ezequiel Dias Foundation (FUNED), Central Laboratory of Public Health of Minas Gerais (Lacen-MG)

9 April, 2018 - 11 April, 2018

Belo Horizonte,

Brazil

Ezequiel Dias Foundation Octavio Magalhães Institute (IOM) Medicines Service Laboratory

23 March, 2011 - 25 March, 2011

Belo Horizonte,

Brazil

Famy Care Ltd

3 September, 2012 - 6 September, 2012

Ahmedabad,

India

Famy Care Ltd

7 September, 2011 - 9 September, 2011

Mumbai,

India

Famy Care Ltd, Unit II

18 November, 2013 - 22 November, 2013

Valsad,

India

Farmak JSC

20 January, 2020 - 23 January, 2020

Kyiv,

Ukraine

FARMOUS (Pty) Ltd - Desk Review

27 May, 2019 - 30 May, 2019

Bloemfontein,

South Africa

Federal State Budgetary Scientific Institution "Chumakov Federal Scientific Center for Research & Development of Immune-and-Biological Products", Russian Academy of Sciences (FSBSI) "Chumakov FSC R&D IBP"

11 March, 2018 - 16 March, 2018

Moscow,

Russian Federation

Fuji Chemical Industries Co Ltd, Gohkakizawa Factory - Desk Assessment

3 June, 2020 - 5 June, 2020

Toyama,

Japan

VCP

Fujian Yamei Industry & Trade Co Ltd

17 May, 2019

Fuzhou city,

China

VCP

Gaotang Xingyuan Textile Factory

17 May, 2019

Liaocheng city,

China

Getz Pharma (Pvt) Limited

25 February, 2020 - 28 February, 2020

Karachi,

Pakistan

Getz Pharma (Pvt) Limited

11 September, 2013 - 13 September, 2013

Karachi,

Pakistan

Getz Pharma Pvt Ltd

21 August, 2017 - 24 August, 2017

Karachi,

Pakistan

Gimopharm - Desk Review

24 January, 2019

Longjumeau,

France

GPO-MBP Co Ltd

19 June, 2018 - 22 June, 2018

Chachoengsao,

Thailand

Green Cross Corporation (GCC)

23 July, 2018 - 27 July, 2018

Gyeonggi-do,

Republic of Korea

Grindeks JSC

13 December, 2018 - 14 December, 2018

Riga,

Latvia

Guilin Pharmaceutical Co Ltd

8 May, 2017 - 12 May, 2017

Guilin,

China

Guilin Pharmaceutical Co Ltd

19 July, 2012 - 21 July, 2012

Guilin,

China

Guilin Pharmaceutical Co Ltd

16 July, 2012 - 18 July, 2012

Guangxi,

China

Guilin Pharmaceutical Co Ltd

14 November, 2011 - 17 November, 2011

Guilin,

China

Guilin Pharmaceutical Co Ltd

23 August, 2010 - 26 August, 2010

Guangxi,

China

Guilin Pharmaceutical Co Ltd

25 February, 2010 - 26 February, 2010

Guangxi,

China

GVK Biosciences Pvt Ltd - Desk Review

15 November, 2019

Hyderabad,

India

Haffkine Bio-Pharmaceutical Corporation Ltd (HBPCL)

12 September, 2016 - 16 September, 2016

Mumbai,

India

Hainan Poly Pharma Co Ltd

16 April, 2018 - 20 April, 2018

Haikou City,

China

Hainan Poly Pharma Co Ltd

20 June, 2014

Hainan Province,

China

Hainan Poly Pharma Co Ltd

16 June, 2014 - 20 June, 2014

Hainan Province,

China

Hainan Poly Pharma Co Ltd

21 November, 2011 - 23 November, 2011

Haikou City,

China

Hainan Poly Pharma Co. Ltd, Building 2

14 May, 2012 - 16 May, 2012

Haikou city, Hainan Province,

China

HBM Pharma Sro

27 June, 2018 - 29 June, 2018

Martin,

Slovakia

Health Concepts International

7 March, 2016 - 8 March, 2016

Pathumthani,

Thailand

HEC Pharm Co Ltd - Site 1 and Site 2

16 January, 2014 - 17 January, 2014

Hubei Province,

China

Hemmo Pharmaceuticals Pvt Ltd - Desk Review

29 January, 2019 - 30 January, 2019

Thane,

India

Hetero Drugs Limited (HDL) - Hetero Labs Limited (HLL)

20 June, 2011 - 23 June, 2011

Andhra Pradesh,

India

Hetero Drugs Ltd

26 November, 2012 - 28 November, 2012

Andhra Pradesh,

India

Hetero Laboratories Ltd - Hetero Drugs Ltd

15 September, 2014 - 18 September, 2014

Andhra Pradesh,

India

Hetero Labs (Unit III Jeedimetla) - Desk Assessment

30 August, 2018

Jeedimetla,

India

Hetero Labs Limited - Unit-I

4 March, 2014 - 7 March, 2014

Andhra Pradesh,

India

Hetero Labs Limited (Unit I) - Desk Review

2 September, 2019 - 1 October, 2019

Gaddapotharam,

India

Hetero Labs Limited (Unit-III)

9 October, 2017 - 11 October, 2017

Visakhapatnam,

India

Hetero Labs Limited (Unit-V)

30 October, 2017 - 3 November, 2017

Mahaboob Nagar,

India

Hetero Labs Limited, Unit III

9 June, 2015 - 12 June, 2015

Telangana State,

India

Hetero Labs Ltd, Unit III

13 February, 2012 - 16 February, 2012

Andhra Pradesh,

India

Hetero Labs Ltd, Unit V

6 February, 2012 - 9 February, 2012

Andhra Pradesh,

India

Hetero Labs Ltd, Unit V

23 November, 2010 - 26 November, 2010

Andhra Pradesh,

India

Hetero Labs Ltd, Unit-I

25 January, 2011 - 27 January, 2011

Medak District,

India

Hetero Labs, Unit V

15 June, 2015 - 18 June, 2015

Telangana State,

India

Hisun Pharmaceutical (Hangzhou) Co Ltd

2 September, 2019 - 6 September, 2019

Hangzhou city,

China

Hisun Pharmaceutical (Hangzhou) Co Ltd

2 December, 2014 - 5 December, 2014

Hangzhou City,

China

Hisun Pharmaceutical (Hangzhou) Co Ltd

14 January, 2013 - 17 January, 2013

Hangzhou,

China

Hisun Pharmaceutical (Nantong) Co Ltd

28 January, 2019 - 30 January, 2019

Nantong,

China

Hisun Pharmaceutical (Nantong) Co Ltd

16 January, 2017 - 19 January, 2017

Nantong,

China

Hisun Pharmaceuticals (Hangzhou) Co Ltd

31 July, 2017 - 3 August, 2017

Hangzhou,

China

HLL Lifecare Ltd

16 January, 2017 - 19 January, 2017

Kerala,

India

Hulun Buir North Pharmaceutical Limited Company

14 July, 2015 - 17 July, 2015

Nei Mongol Autonomous Region,

China

Hulunbuir North Pharmaceutical Limited Company

23 July, 2018 - 26 July, 2018

Yakeshi City,

China

Huvepharma Italia S.r.l. - Desk Assessment

10 June, 2019 - 11 June, 2019

San Donato Milanese,

Italy

VCP

Huzhou Wuxing Dongren Textiles Co Ltd

22 March, 2019 - 23 March, 2019

Huzhou,

China

IL-YANG Pharm Co Ltd

3 July, 2017 - 5 July, 2017

Seoul,

Republic of Korea

Immacule Lifesciences Pvt Ltd - Desk Assessment

5 November, 2019

Himachal Pradesh,

India

Incepta Pharmaceuticals Ltd

15 March, 2020 - 16 March, 2020

Dhaka,

Bangladesh

Indian Pharmacopoeia Commission Laboratory (IPCL)

9 October, 2014 - 11 October, 2014

Ghaziabad,

India

INFARMED I.P. - Desk Review

8 March, 2019 - 14 March, 2019

Lisboa,

Portugal

INFARMED I.P. Quality Control Division

16 July, 2015 - 17 July, 2015

Lisbon,

Portugal

InphA GmbH - Institute for Pharmaceutical and Applied Analytics - Desk Review

23 May, 2019

Bremen,

Germany

Institut Pasteur de Dakar

7 November, 2016 - 11 November, 2016

Dakar,

Senegal

Institute of Drug Quality Control (IDQC-HCMC)

17 February, 2020 - 19 February, 2020

Ho Chi Minh City,

Viet Nam

Institute of Drug Quality Control Ho Chi Minh City (IDQC)

17 October, 2016 - 19 October, 2016

Ho Chi Minh City,

Viet Nam

Institute of Technology on Immunobiologicals - Bio-Manguinhos Oswaldo Cruz Foundation - Fiocruz

15 February, 2016 - 19 February, 2016

Rio de Janeiro,

Brazil

Instituto de Tecnologia em Fármacos (Farmanguinhos)

25 April, 2018 - 27 April, 2018

Rio de Janeiro,

Brazil

Instituto Nacional de Contrôle de Qualidade em Saude (INCQS)

9 April, 2013 - 11 April, 2013

Rio de Janeiro,

Brazil

Instituto Nacional de Controle de Qualidade em Saúde (INCQS)/FIOCRUZ

19 April, 2018 - 24 April, 2018

Rio de Janeiro,

Brazil

International Pharmaceutical Research Centre

13 May, 2015 - 16 May, 2015

Amman,

Jordan

Intertek (Schweiz) AG - Desk Review

10 May, 2019

Reinach,

Switzerland

IPCA Laboratories Limited

14 September, 2012 - 18 September, 2012

Indore,

India

IPCA Laboratories Limited

30 November, 2010 - 3 December, 2010

Madhya Pradesh,

India

Ipca Laboratories Limited, Ratlam

28 May, 2018 - 31 May, 2018

Ratlam,

India

Ipca Laboratories Limited, Ratlam

28 May, 2018 - 31 May, 2018

Ratlam,

India

IPCA Laboratories Ltd

14 October, 2019 - 17 October, 2019

Indore,

India

IPCA Laboratories Ltd

18 March, 2014 - 20 March, 2014

Indore,

India

Ipca Laboratories Ltd

20 November, 2012 - 23 November, 2012

Silvassa,

India

IPCA Laboratories Ltd

10 September, 2012 - 12 September, 2012

Madhya Pradesh,

India

IPCA Laboratories Ltd

7 February, 2011 - 10 February, 2011

Pithampur,

India

Ipca Laboratories Ltd, Pithampur-Hormone

12 March, 2019 - 15 March, 2019

Pithampur,

India

Jai Pharma Ltd

18 April, 2016 - 21 April, 2016

Ahmedabad,

India

Jai Pharma Ltd - Unit-II

12 April, 2016 - 15 April, 2016

Valsad,

India

Janssen Vaccines (Berna Biotech Korea Corp)

13 June, 2016 - 17 June, 2016

Incheon,

Republic of Korea

Japan BCG Laboratory

15 May, 2019 - 17 May, 2019

Tokyo,

Japan

Jeevan Scientific Technology Ltd (JSTL)

4 March, 2019 - 7 March, 2019

Telangana,

India

Jiangsu Chengxin Pharmaceutical Co Ltd

21 October, 2019 - 24 October, 2019

Jiangsu,

China

Jiangsu Chengxin Pharmaceutical Co Ltd

22 January, 2018 - 24 January, 2018

Jiangsu,

China

Jiangsu Grand Xianle Pharmaceutical Co Ltd

19 July, 2016 - 22 July, 2016

Jiangsu,

China

Joint Stock Company JSC "Biocom"

16 July, 2012 - 18 July, 2012

Stavropol,

Russian Federation

Joint Stock Company JSC "Biocom"

8 November, 2010 - 12 November, 2010

Stavropol,

Russian Federation

Joint-Stock Company "Halychpharm"

10 December, 2018 - 14 December, 2018

Lviv city,

Ukraine

KPC Pharmaceuticals Inc

16 November, 2015 - 18 November, 2015

Kunming,

China

KPC Pharmaceuticals Inc - Desk Review

17 September, 2019 - 18 September, 2019

Kunming,

China

Kunming Pharmaceutical Corporation

25 June, 2012 - 28 June, 2012

Kunming,

China

Laboratoire National de Controle des Medicaments (LNCM Morocco)

26 March, 2018 - 28 March, 2018

Rabat,

Morocco

Laboratoire National de Contrôle des Produits Pharmaceutiques

28 April, 2010 - 29 April, 2010

Alger,

Algeria

Laboratoire National de Contrôle des Produits Pharmaceutiques (LNCPP)

23 April, 2014 - 24 April, 2014

Algiers,

Algeria

Laboratories KABS Inc - Desk Review

3 October, 2019

Québec,

Canada

Laboratorio de control de calidad de medicamentos y toxicologia/Laboratory for the Quality Control of Drugs and Toxicology (CONCAMYT)

13 August, 2013 - 14 August, 2013

La Paz,

Bolivia (Plurinational State of)

Laboratorio de control de calidad de medicamentos y toxicología/Laboratory for the Quality Control of Drugs and Toxicology (CONCAMYT)

22 March, 2010 - 23 March, 2010

La Paz,

Bolivia (Plurinational State of)

Laboratório Estadual de Saúde Publica Dr Giovanni Cysneiros (LACEN-GO)

13 April, 2018 - 17 April, 2018

Goiâna,

Brazil

Laboratórios Basi - Indústria Farmacêutica S.A. - Desk Review

29 May, 2019 - 5 June, 2019

Mortagua,

Portugal

Laboratorios Leon Farma - Desk Review

27 December, 2019

Leon,

Spain

Laboratory of Pharmaceutical Analysis, State Expert Centre, Ministry of Health

7 February, 2013 - 8 February, 2013

Kyiv,

Ukraine

Laboratory of Pharmaceutical Analysis, State Expert Centre, Ministry of Health of Ukraine (LPA)

11 February, 2020 - 14 February, 2020

Kiev,

Ukraine

Laboratory of the Mission for Essential Drugs & Supplies (MEDS)

27 August, 2012 - 28 August, 2012

Nairobi,

Kenya

Lambda Therapeutic Research Ltd

11 December, 2017 - 15 December, 2017

Ahmedabad,

India

Lambda Therapeutic Research Ltd

15 October, 2012 - 18 October, 2012

Ahmedabad and Navi Mumbai,

India

Laurus Labs Limited

25 August, 2014 - 28 August, 2014

Andhra Pradesh,

India

Laurus Labs Limited - Desk Assessment

3 May, 2020

Visakhapatnam,

India

Laurus Labs Limited (Unit-1 & Unit-3)

4 September, 2017 - 7 September, 2017

Visakhapatnam,

India

Laurus Labs Limited (Unit-2)

13 March, 2017 - 17 March, 2017

Hyderabad,

India

Laurus Labs Pvt Ltd

9 April, 2013 - 12 April, 2013

Visakhapatnam,

India

Laurus Labs Pvt Ltd (formerly: Aptuit Laurus Pvt Ltd)

18 July, 2011 - 21 July, 2011

Visakhapatnam,

India

LG Life Sciences Ltd, Iksan Plant

31 August, 2015 - 4 September, 2015

Jeollabuk-do,

Republic of Korea

LG Life Sciences Ltd, Osong Plant

7 September, 2015 - 11 September, 2015

Chungcheongbuk-do,

Republic of Korea

Liaoyuan Silver Eagle Pharmaceutical Co Ltd

8 July, 2019 - 11 July, 2019

Liaoyuan,

China

Lifepoint Multi-Speciality Hospital (LPR)

4 December, 2019 - 6 December, 2019

Pune,

India

Livzon (Group) Pharmaceutical Factory

30 October, 2017 - 2 November, 2017

Guangdong,

China

Livzon Group Fuzhou Fuxing Pharmaceutical Co Ltd

13 March, 2017 - 17 March, 2017

Fuzhou city,

China

Livzon Group Fuzhou Fuxing Pharmaceutical Co Ltd

6 July, 2015 - 10 July, 2015

Fuzhou City,

China

Livzon Group Fuzhou Fuxing Pharmaceutical Co Ltd - Desk Review

28 October, 2019

Fuzhou City,

China

Lonzeal Pharmaceuticals Co, Ltd

8 May, 2012 - 11 May, 2012

Shijiazhuang,

China

Lotus Labs Pvt Ltd - Desk Review

23 March, 2020 - 24 March, 2020

Bangalore,

India

Lotus Pvt Ltd

25 April, 2013 - 30 April, 2013

Bangalore and Chennai,

India

VCP

LTC Yamei Rwanda Ltd

19 November, 2019 - 20 November, 2019

Kigali,

Rwanda

Lupin Limited

19 September, 2018 - 21 September, 2018

Nagpur,

India

Lupin Limited

10 June, 2014 - 13 June, 2014

Thane,

India

Lupin Limited

17 February, 2014 - 20 February, 2014

Jammu,

India

Lupin Limited

2 February, 2012 - 4 February, 2012

Ankleshwar,

India

Lupin Limited

16 February, 2011 - 18 February, 2011

Tarapur,

India

Lupin Limited - Desk Assessment

7 July, 2020

Aurangabad,

India

Lupin Ltd

12 March, 2018 - 16 March, 2018

Jammu,

India

Lupin Ltd

7 November, 2017 - 10 November, 2017

Aurangabad,

India

Lupin Ltd

30 August, 2017 - 1 September, 2017

Gujarat,

India

Lupin Ltd

17 June, 2014 - 20 June, 2014

Aurangabad,

India

Lupin Ltd

20 February, 2012 - 23 February, 2012

Aurangabad,

India

Lupin Ltd

16 August, 2011 - 19 August, 2011

Jammu,

India

Lupin Ltd

9 December, 2010 - 10 December, 2010

Aurangabad,

India

Lupin Ltd - Tarapur

21 August, 2017 - 24 August, 2017

Tarapur,

India

Lupin Ltd – Desk Assessment

12 June, 2020

Visakhapatnam,

India

Lupin Ltd (Unit-1)

18 March, 2019 - 22 March, 2019

Pithampur,

India

M&L Laboratory Services (Pty) Ltd

12 December, 2016 - 13 December, 2016

Johannesburg,

South Africa

Macleods (N2 (Unit VI) - Desk Review

27 August, 2018

Village Theda Baddi,

India

Macleods Pharmaceuticals Limited

20 February, 2012 - 24 February, 2012

Himachal Pradesh,

India

Macleods Pharmaceuticals Limited, Unit 2

4 June, 2012 - 7 June, 2012

Daman,

India

Macleods Pharmaceuticals Limited, Unit V

12 June, 2012 - 14 June, 2012

Gujarat,

India

Macleods Pharmaceuticals Ltd

10 July, 2017 - 14 July, 2017

Mumbai,

India

Macleods Pharmaceuticals Ltd

8 August, 2016 - 12 August, 2016

Gujarat,

India

Macleods Pharmaceuticals Ltd

18 April, 2016 - 22 April, 2016

Kachigam Daman,

India

Macleods Pharmaceuticals Ltd

14 July, 2014 - 17 July, 2014

Solan, Himachal Pradesh,

India

Macleods Pharmaceuticals Ltd

26 May, 2014 - 29 May, 2014

Gujarat,

India

Macleods Pharmaceuticals Ltd

20 May, 2014 - 23 May, 2014

Kachigam Daman,

India

Macleods Pharmaceuticals Ltd

8 February, 2013 - 12 February, 2013

Mumbai,

India

Macleods Pharmaceuticals Ltd

15 February, 2010 - 19 February, 2010

Kachigam, Daman,

India

MacLeods Pharmaceuticals Ltd - Unit-2, Phase I

3 June, 2019 - 7 June, 2019

Daman,

India

Macleods Pharmaceuticals Ltd (Unit 2) - Desk Review

22 October, 2018

Shanti Nagar,

India

Macleods Pharmaceuticals Ltd, Phase I

30 May, 2011 - 3 June, 2011

Daman,

India

Mangalam Drugs & Organics Ltd

17 November, 2014 - 20 November, 2014

Vapi,

India

Mangalam Drugs & Organics Ltd

28 November, 2011 - 30 November, 2011

Gujarat,

India

Mangalam Drugs & Organics Ltd, Unit 1

17 January, 2011 - 20 January, 2011

Gujarat,

India

Mangalam Drugs and Organics Ltd, Unit I

1 May, 2018 - 4 May, 2018

Vapi,

India

Manipal AcuNova KH Clinical Research Centre

2 July, 2012 - 6 July, 2012

Manipal,

India

Maphar Laboratories

19 November, 2019 - 22 November, 2019

Casablanca,

Morocco

Maphar Laboratories

8 November, 2016 - 11 November, 2016

Casablanca,

Morocco

Maphar Laboratories

8 February, 2010 - 11 February, 2010

Casablanca,

Morocco

Maphar Laboratories Ltd

21 January, 2013 - 24 January, 2013

Casablanca,

Morocco

Matrix Laboratories Limited

14 February, 2011 - 16 February, 2011

Medak District,

India

Matrix Laboratories Limited (Xiamen)

19 March, 2012 - 22 March, 2012

Xiamen, Fujian Province,

China

Matrix Laboratories Ltd

20 May, 2010 - 21 May, 2010

Hyderabad,

India

May & Baker Nigeria Plc

5 May, 2014 - 7 May, 2014

Ota,

Nigeria

Medicines Control Authority of Zimbabwe (MCAZ)

20 January, 2014 - 21 January, 2014

Harare,

Zimbabwe

Meditab Specialities Ltd

17 July, 2019 - 19 July, 2019

Goa,

India

Meditab Specialities Pvt Ltd

10 March, 2014 - 13 March, 2014

Maharashtra,

India

Meditab Specialities Pvt Ltd

13 November, 2013 - 15 November, 2013

Goa,

India

Meditab Specialities Pvt Ltd

8 February, 2011 - 11 February, 2011

Goa,

India

Meditab Specialities Pvt. Ltd

19 April, 2011 - 22 April, 2011

Satara,

India

Meditab Specialties Pvt Ltd

20 June, 2016 - 23 June, 2016

Kundaim, Goa,

India

IVD

Meril Diagnostics Pvt Ltd - Desk Review

15 June, 2020 - 17 June, 2020

Vapi,

India

Micro Labs (Hosur)

10 July, 2017 - 14 July, 2017

Hosur,

India

Micro Labs Limited

8 December, 2015 - 10 December, 2015

Bangalore,

India

Micro Labs Limited

19 July, 2012 - 21 July, 2012

Bangalore,

India

Micro Labs Limited

17 April, 2012 - 20 April, 2012

Hosur,

India

Micro Labs Limited

15 March, 2010 - 18 March, 2010

Goa,

India

Micro Labs Limited - Unit-3

7 December, 2015 - 10 December, 2015

Hosur,

India

Micro Labs Ltd

15 June, 2016 - 18 June, 2016

Verna, Goa,

India

Micro Labs Ltd

15 January, 2013 - 18 January, 2013

Goa,

India

Micro Therapeutic Research Labs Pvt Ltd

20 November, 2017 - 24 November, 2017

Chennai,

Indonesia

Micro Therapeutics Research Labs Pvt Ltd

21 November, 2011 - 24 November, 2011

Chennai,

India

Milan Laboratories (India) Pvt Ltd

4 February, 2019 - 8 February, 2019

Mumbai,

India

VCP

Minh Hung Tien Giang Co Ltd

10 February, 2020 - 12 February, 2020

Tien Giang,

Viet Nam

Minsheng Group Shaoxing Pharmaceutical Co Ltd

9 January, 2017 - 12 January, 2017

Shaoxing,

China

Minsheng Group Shaoxing Pharmaceutical Co Ltd - Desk Review

28 October, 2019

Shaoxing city,

China

Mission for Essential Drugs and Supplies (MEDS)

15 April, 2019 - 16 April, 2019

Nairobi,

Kenya

Mission for Essential Drugs and Supplies (MEDS)

22 June, 2015 - 23 June, 2015

Nairobi,

Kenya

Mission Vivacare Limited

28 March, 2011 - 31 March, 2011

Pithampur,

India

MSN Laboratories Private Limited

13 May, 2013 - 15 May, 2013

Andhra Pradesh,

India

MSN Laboratories Pvt Ltd

22 January, 2018 - 24 January, 2018

Telangana,

India

MSN Laboratories Pvt Ltd

7 April, 2014 - 10 April, 2014

Andhra Pradesh,

India

MSN Laboratories Pvt Ltd - Desk Review

1 May, 2020

Telangana,

India

MSN Laboratories Pvt Ltd, Formulations Division, Unit-II

20 March, 2017 - 23 March, 2017

Telangana,

India

MSN Pharmachem Private Limited

14 October, 2015 - 16 October, 2015

Telangana,

India

MSN Pharmachem Private Limited

14 October, 2015 - 16 October, 2015

Telangana,

India

MSN Pharmachem Private Limited

16 April, 2012 - 19 April, 2012

Andhra Pradesh,

India

Mylan (former Matrix) Laboratories Ltd (Unit-VIII)

15 August, 2011 - 19 August, 2011

Vizianagaram District,

India

Mylan Laboratories Limited

23 May, 2018 - 25 May, 2018

Indore,

India

Mylan Laboratories Limited

9 January, 2017 - 13 September, 2017

Hosur,

India

Mylan Laboratories Limited

9 June, 2015 - 12 June, 2015

Nashik, Sinnar,

India

Mylan Laboratories Limited

17 January, 2012 - 20 January, 2012

Aurangabad,

India

Mylan Laboratories Limited - Desk review

5 March, 2019

Ahmedabad,

India

Mylan Laboratories Limited - Specialty Formulation Facility

10 September, 2018 - 19 September, 2018

Bangalore,

India

Mylan Laboratories Limited (Unit-8)

3 October, 2017 - 6 October, 2017

Vizianagaram,

India

Mylan Laboratories Limited (Unit-9)

17 July, 2017 - 21 July, 2017

Visakhapatnam,

India

Mylan Laboratories Ltd

10 June, 2019 - 14 June, 2019

Hosur,

India

Mylan Laboratories Ltd

4 September, 2017 - 8 September, 2017

Hyderabad,

India

Mylan Laboratories Ltd

20 March, 2015 - 27 March, 2015

Hyderabad,

India

Mylan Laboratories Ltd

21 January, 2015 - 24 January, 2015

Kazipally,

India

Mylan Laboratories Ltd

16 January, 2015 - 20 January, 2015

Visakhapatnam,

India

Mylan Laboratories Ltd

7 October, 2014 - 10 October, 2014

Pithampur,

India

Mylan Laboratories Ltd

9 September, 2014 - 12 September, 2014

Andhra Pradesh,

India

Mylan Laboratories Ltd

24 October, 2013 - 26 October, 2013

Madhya Pradesh,

India

Mylan Laboratories Ltd

9 May, 2013 - 11 May, 2013

Aurangabad,

India

Mylan Laboratories Ltd

3 January, 2013 - 5 January, 2013

Andhra Pradesh,

India

Mylan Laboratories Ltd

25 June, 2012 - 28 June, 2012

Maharashtra,

India

Mylan Laboratories Ltd

23 April, 2012 - 26 April, 2012

Andhra Pradesh,

India

Mylan Laboratories Ltd

6 November, 2017 - 10 November, 2017

Nashik,

India

Mylan Laboratories Ltd - Unit 2

18 April, 2016 - 21 April, 2016

Telangana,

India

Mylan Laboratories Ltd (Unit-1) - Desk Review

7 October, 2019

Gaddapotharam,

India

Mylan Laboratories Ltd (Unit-10) - Desk Review

30 October, 2019 - 31 October, 2019

Visakhapatnam,

India

Mylan Laboratories Ltd (Unit-2) - Desk Review

7 October, 2019

Gaddapotharam,

India

Mylan Laboratories Ltd (Waluj)

12 July, 2016 - 15 July, 2016

Hyderabad,

India

Mylan Laboratories Ltd, Unit III

22 August, 2011 - 26 August, 2011

Hyderabad,

India

Mylan Laboratories Ltd, Unit-9

12 December, 2011 - 14 December, 2011

Visakhapatnam,

India

Mylan Laboratories Ltd, Unit-III

16 June, 2014 - 19 June, 2014

Hyderabad,

India

Mylan Pharmaceuticals INC (MPI) - Desk Review

7 February, 2019

Morgantown,

United States of America

National Center for Expertise of Medicines and Medical Devices (NCEMMD)

17 June, 2019 - 19 June, 2019

Karaganda,

Kazakhstan

National Drug Quality Control Laboratory (NDQCL)

19 June, 2019 - 20 June, 2019

Kampala,

Uganda

National Drug Quality Control Laboratory of NDA Uganda (NDQCL-NDA)

4 September, 2014 - 5 September, 2014

Kampala,

Uganda

National Institute of Drug Quality Control of Viet Nam (NIDQC)

4 December, 2014 - 6 December, 2014

Hanoi,

Viet Nam

National Institute of Drug Quality Control of Viet Nam (NIDQC)

25 April, 2012 - 27 April, 2012

Hanoi,

Viet Nam

National Institute of Drug Quality Control of Vietnam (NIDQC)

21 February, 2020 - 25 February, 2020

Hanoi city,

Viet Nam

National Institutes for Food and Drug Control (NIFDC - PR China: Divisions of Chemical Drugs, Antibiotics, Narcotic Drugs and Pharmacology)

22 October, 2013 - 24 October, 2013

Beijing,

China

National Institutes for Food and Drug Control (NIFDC)

27 August, 2018 - 30 August, 2018

Beijing,

China

National Institutes for Food and Drug Control (NIFDC) Divisions of Chemical Drugs, Antibiotics, Narcotic Drugs and Pharmacology of the Institute for Chemical Drug Control

23 April, 2012 - 25 April, 2012

Beijing,

China

National Quality Control Laboratory (NQCL)

24 June, 2015 - 26 June, 2015

Nairobi,

Kenya

National Quality Control Laboratory for Drugs and Medical Devices

21 September, 2011 - 23 September, 2011

Nairobi,

Kenya

National Quality Control Laboratory of Drug and Food (NQCLDF)

18 February, 2019 - 20 February, 2019

Jakarta Pusat,

Indonesia

National Quality Control Laboratory, Tanzania Food and Drug Authority Laboratory (TFDA)

23 January, 2014 - 24 January, 2014

Dar es Salaam,

United Republic of Tanzania

NCPC New Preparation Branch Factory

20 October, 2014 - 24 October, 2014

Hebei,

China

VCP

Net Health Limited

18 June, 2018 - 19 June, 2018

Arusha,

United Republic of Tanzania

Neuland Laboratories Ltd, Unit-I

6 February, 2018 - 9 February, 2018

Hyderabad,

India

North China Pharm Co (NCPC) - New Preparation Branch Factory

14 January, 2019 - 18 January, 2019

Hebei,

China

North China Pharmaceutical Co Ltd

1 February, 2016 - 5 February, 2016

Hebei,

China

North China Pharmaceutical Huasheng Co Ltd

9 July, 2012 - 12 July, 2012

Shijiazhuang,

China

Norwich Clinical Services Pvt Ltd

18 June, 2018 - 22 June, 2018

Bangalore,

India

Norwich Clinical Services Pvt Ltd

21 January, 2014 - 24 January, 2014

Bangalore,

India

Novartis Pharmaceuticals Corporation

25 October, 2010 - 28 October, 2010

Suffern, NY,

United States of America

Official Medicines Control Laboratory (OMCL), Laboratory of HALMED

20 July, 2015 - 22 July, 2015

Zagreb,

Croatia

Olon Active Pharmaceutical Ingredient India Pvt Ltd

14 October, 2019 - 17 October, 2019

Mahad,

India

Optimus Drugs Pvt Ltd

25 February, 2019 - 28 February, 2019

Telangana,

India

Optimus Drugs Pvt Ltd

15 August, 2016 - 18 August, 2016

Telangana State,

India

IVD

Orchid Biomedical Systems

23 January, 2019 - 25 January, 2019

Goa,

India

Orchid Chemicals and Pharmaceuticals Limited

19 December, 2011 - 20 December, 2011

Tamil Nadu,

India

Otsuka Pharmaceutical Co Ltd - Second Tokushima Factory - Desk Assessment

17 June, 2020 - 18 June, 2020

Tokushima,

Japan

Otsuka Pharmaceutical Co Ltd - Tokushima Itano Factory - Desk Assessment

1 July, 2020 - 3 July, 2020

Tokushima,

Japan

Oxalis Labs

13 March, 2018 - 16 March, 2018

Solan,

India

Oxalis Labs

27 April, 2015 - 30 April, 2015

Solan, Himachal Pradesh,

India

Panacea Biotec Limited

15 October, 2018 - 19 October, 2018

Punjab,

India

Panacea Biotec Limited (PBL)

5 December, 2016 - 9 December, 2016

Solan,

India

Panexcell Clinical Lab Pvt Ltd

24 July, 2018 - 27 July, 2018

Navi Mumbai,

India

Pen Tsao Chemical & Pharmaceutical Industry Co Ltd

4 July, 2017 - 7 July, 2017

Shanghai,

China

Pen Tsao Chemical & Pharmaceutical Industry Co Ltd

16 November, 2015 - 19 November, 2015

Shanghai,

China

Pen Tsao Chemical & Pharmaceutical Industry Co Ltd

27 November, 2012 - 29 November, 2012

Shanghai,

China

Pharma Medica Research Inc (PMRI) - Desk review

26 March, 2020

Ontario,

Canada

Pharmacie et Aide Humanitaire Médico-Pharmaceutique (PAH-CHMP)

26 September, 2013 - 27 September, 2013

Clermont-Ferrand,

France

Piramal Clinical Research

20 June, 2011 - 24 June, 2011

Ramanthapur,

India

Piramal Healthcare UK Limited - Desk Review

12 September, 2019

Northumberland,

United Kingdom of Great Britain and Northern Ireland

IVD

Plexus Manufacturing Sdn Bhd

1 August, 2019 - 2 August, 2019

Pulau Pinang,

Malaysia

Prime Health (Pvt) Ltd (PHPL)

22 January, 2020 - 24 January, 2020

Islamabad,

Pakistan

PROXY Laboratories B.V.

7 January, 2014 - 9 January, 2014

Leiden,

Netherlands (Kingdom of the)

Proxy Laboratories B.V.

24 July, 2010 - 26 July, 2010

Leiden,

Netherlands (Kingdom of the)

PT BIO FARMA (Persero)

18 March, 2019 - 22 March, 2019

Bandung,

Indonesia

PT Caprifarmindo Laboratories

20 January, 2020 - 24 January, 2020

Bandung,

Indonesia

PT Kalbe Farma Tbk

24 May, 2018 - 28 May, 2018

Bekasi,

Indonesia

PT SANBE FARMA Penicillin Plant

20 February, 2017 - 21 February, 2017

Bandung,

Indonesia

PT SANBE FARMA Sterile Preparations Plant

14 May, 2018 - 16 May, 2018

Bandung,

Indonesia

PT SANBE FARMA Sterile Preparations Plant

13 February, 2017 - 17 February, 2017

Bandung,

Indonesia

PT Tunggal Idaman Abdi

18 May, 2018 - 22 May, 2018

Jakarta,

Indonesia

PT. Sanbe Farma Laboratory - Unit 3 - Sterile Preparations Plant

27 January, 2020 - 28 January, 2020

Bandung,

Indonesia

PT. Tunggal Idaman Abdi

23 February, 2017 - 28 February, 2017

Jakarta,

Indonesia

Qilu Pharmaceutical Co Ltd

16 January, 2017 - 20 January, 2017

Jinan,

China

Qilu Tianhe Pharmaceutical Co Ltd

19 January, 2016 - 22 January, 2016

Jinan,

China

Qilu Tianhe Pharmaceutical Co Ltd

21 January, 2013 - 24 January, 2013

Jinan,

China

Qilu Tianhe Pharmaceutical Co Ltd

21 January, 2013 - 24 January, 2013

Jinan,

China

Qinhuangdao Zizhu Pharmaceutical (QZP) Co Ltd

15 October, 2018 - 19 October, 2018

Qinhuangdao,

China

Qinhuangdao Zizhu Pharmaceutical Co Ltd

13 October, 2015 - 16 October, 2015

Qinhuangdao,

China

Qinhuangdao Zizhu Pharmaceutical Co Ltd

15 May, 2012 - 18 May, 2012

Qinhuangdao,

China

QPS Bioserve India Ltd

3 October, 2017 - 6 October, 2017

Hyderabad,

India

Quality Chemical Industries Ltd (QCIL)

25 January, 2010 - 28 January, 2010

Kampala,

Uganda

Quality Chemical Industries Ltd (QCIL) -

3 September, 2012 - 5 September, 2012

Kampala,

Uganda

Questa Care Ltd

15 August, 2016 - 17 August, 2016

Kenya,

Kenya

R-Pharm Germany GmbH - Desk Assessment

1 June, 2020 - 3 June, 2020

Illertissen,

Germany

RA Chem Pharma Ltd

16 July, 2016 - 19 July, 2016

Balanagar, Hyderabad,

India

RA Chem Pharma Ltd, Clinical Research & Biosciences Division

12 February, 2018 - 16 February, 2018

Balanagar,

India

Ranbaxy Laboratories Limited

8 December, 2011 - 9 December, 2011

New Delhi,

India

Ranbaxy Laboratories Limited

23 August, 2011 - 26 August, 2011

Mohali,

India

Ranbaxy Laboratories Limited, Unit I & II

18 April, 2011 - 21 April, 2011

Paonta Sahib,

India

Ranbaxy Laboratories Ltd

2 September, 2013 - 6 September, 2013

Gurgaon,

India

Raptim Research Ltd

23 October, 2017 - 27 October, 2017

Navi Mumbai,

India

Raptim Research Pvt Ltd - Desk Assessment

16 July, 2020

Navi Mumbai,

India

Republican Control and Analytical Laboratory (RCAL) of the Republican Unitary Enterprise Centre for Expertise and Testing in Health Care - Ministry of Health of the Republic of Belarus

5 December, 2018 - 7 December, 2018

Minsk,

Belarus

Republican Control and Analytical Laboratory of the Republican Unitary Enterprise "Centre for Expertise and Testing in Health Care", Ministry of Health Care

26 July, 2011 - 28 July, 2011

Minsk,

Belarus

Republican Control and Analytical Laboratory of the Republican Unitary Enterprise "Centre of Expertise and Testing in Health Care", Ministry of Health Care

13 May, 2014 - 14 May, 2014

Minsk,

Belarus

Republican Control and Analytical Laboratory of the Republican Unitary Enterprise "Centre of Expertise and Testing in Health Care", Ministry of Health Care

13 May, 2014 - 14 May, 2014

Minsk,

Belarus

IVD

Roche Diagnostics GmbH

4 December, 2019

Mannheim,

Germany

Roszdravnadzor

19 November, 2013 - 21 November, 2013

Rostov,

Russian Federation

Sandoz Private Limited

14 February, 2011 - 17 February, 2011

Mumbai,

India

Sandoz Private Limited - Desk Assessment

8 June, 2020 - 12 June, 2020

Navi Mumbai,

India

Sandoz SA (Pty) Ltd

12 April, 2010 - 15 April, 2010

Kempton Park,

South Africa

Sanofi Healthcare Private Limited

9 December, 2019 - 13 December, 2019

Telangana,

India

Sanofi Pasteur France

3 June, 2015 - 5 June, 2015

Val de Reuil, Normandy,

France

Sanofi Pasteur Marcy-l'Etoile

27 May, 2015 - 29 May, 2015

Lyon,

France

Saurav Chemicals Limited

21 October, 2019 - 24 October, 2019

Punjab,

India

Saurav Chemicals Limited

16 July, 2013 - 19 July, 2013

Punjab,

India

Saurav Chemicals Ltd

25 April, 2016 - 28 April, 2016

Panchkula,

India

Scientific Centre on Expertise of Medical Application Products

24 January, 2011 - 27 January, 2011

Moscow,

Russian Federation

IVD

SD Biosensor Inc

8 April, 2019 - 10 April, 2019

Chungcheongbuk-do,

Republic of Korea

Second Pharma Co Ltd

10 November, 2015 - 13 November, 2015

Shang Yu City,

China

Second Pharma Co Ltd

11 December, 2012 - 14 December, 2012

Zhejiang,

China

Second Pharma Co Ltd - Desk Review

26 July, 2019

Shangyu City,

China

Semler Research Center Pvt. Ltd

12 July, 2010 - 16 July, 2010

Bangalore,

India

Semler Research Centre Pvt Ltd

25 March, 2013 - 28 March, 2013

Bangalore,

India

Semler Research Centre Pvt Ltd

11 July, 2011 - 15 July, 2011

Bangalore,

India

Sequent Scientific Limited

6 December, 2011 - 8 December, 2011

Karnataka,

India

Serum Institute of India Pvt Ltd

15 July, 2019 - 19 July, 2019

Pune,

India

Serum Institute of India Pvt Ltd

29 January, 2018 - 2 February, 2018

Pune,

India

SGS India Pvt Ltd

28 October, 2016 - 31 October, 2016

Mumbai,

India

SGS India Pvt Ltd - Life Science

9 December, 2019 - 12 December, 2019

Chennai,

India

SGS India Pvt Ltd (Life Science Services)

26 August, 2013 - 28 August, 2013

Chennai,

India

SGS India Pvt Ltd (Life Science Services)

19 July, 2010 - 21 July, 2010

Chennai,

India

SGS Lab Simon

17 September, 2019 - 20 September, 2019

Wavre,

Belgium

SGS Lab Simon S.A.

13 October, 2010 - 15 October, 2010

Wavre,

Belgium

Shanghai Dahua Pharmaceutical Co

12 March, 2018 - 15 March, 2018

Shanghai,

China

Shanghai Dahua Pharmaceutical Co Ltd

21 May, 2012 - 24 May, 2012

Shanghai,

China

Shanghai Dahua Pharmaceutical Company

8 June, 2015 - 12 June, 2015

Shanghai,

China

Shanghai Desano Bio-Pharmaceutical Co Ltd

7 January, 2015 - 9 January, 2015

Shanghai,

China

Shanghai Desano Chemical Pharmaceutical Co Ltd

15 January, 2019 - 18 January, 2019

Shanghai,

China

Shanghai Desano Chemical Pharmaceuticals Co Ltd

20 May, 2013 - 24 May, 2013

Shanghai,

China

Shanghai Desano Chemical Pharmaceuticals Co., Ltd

15 March, 2011 - 18 March, 2011

Shanghai,

China

VCP

Shanghai Gongtai Textile Co Ltd

26 March, 2019

Taicang city,

China

Shanghai Harvest Pharmaceutical Co Ltd

21 January, 2019 - 24 January, 2019

Shanghai,

China

Shanghai Harvest Pharmaceutical Co Ltd

20 March, 2017 - 23 March, 2017

Shanghai,

China

Shanghai Shyndec Pharmaceutical (Haimen) Co Ltd

24 August, 2015 - 27 August, 2015

Haimen,

China

Shanghai Xuhui Central Hospital

22 October, 2012 - 25 October, 2012

Shanghai,

China

Shanghai Xuhui Central Hospital

15 June, 2010 - 17 June, 2010

Shanghai,

China

Shanghai Zhongxi Sunve Pharmaceutical Co Ltd

19 November, 2012 - 22 November, 2012

Shanghai,

China

Shangyu Jingxin Pharmaceutical Co Ltd

21 January, 2019 - 24 January, 2019

Zhejiang Province,

China

Shangyu Jingxin Pharmaceutical Co Ltd

18 August, 2015 - 21 August, 2015

Shangyu City,

China

Shantha Biotechnics Private Limited

6 February, 2017 - 10 February, 2017

Hyderabad,

India

Shasun Pharmaceuticals Limited

13 March, 2012 - 16 March, 2012

Puducherry,

India

Shasun Pharmaceuticals Ltd

23 April, 2015 - 25 April, 2015

Puducherry,

India

Shasun Pharmaceuticals Ltd

29 November, 2012 - 1 December, 2012

Cuddalore,

India

Shenyang Antibiotic Manufacturer

30 July, 2018 - 2 August, 2018

Shenyang,

China

Shenyang Antibiotic Manufacturer Ltd

20 July, 2015 - 22 July, 2015

Shenyang,

China

Shenzhen Institute for Drug Control (Shenzhen Testing Center of Medical Devices)

14 December, 2017 - 16 December, 2017

Shenzhen,

China

Shijiazhuang Lonzeal Pharmaceuticals Co Ltd

15 May, 2017 - 19 May, 2017

Shijiazhuang,

China

VCP

Shobikaa Impex Pvt Ltd

11 February, 2019 - 13 February, 2019

Karur,

India

Shougang Fukang Pharmaceutical Co Ltd

2 February, 2015 - 5 February, 2015

Shandong,

China

Shouguang Fukang Pharmaceutical Co Ltd - Desk Review

21 October, 2019

Shouguang city,

China

VCP

Shree Dutt Agrochem

15 February, 2019 - 16 February, 2019

Gujarat,

India

Signa S.A. de C.V.

26 March, 2012 - 28 March, 2012

Toluca,

Mexico

Sinopharm Zhijun (Shenzhen) Pharmaceutical Co Ltd

21 January, 2019 - 25 January, 2019

Shenzhen,

China

Sinopharm Zhijun (Shenzhen) Pharmaceuticals Co Ltd

12 October, 2015 - 16 October, 2015

Shenzhen,

China

Sinovac Biotech Co Ltd

22 May, 2017 - 26 May, 2017

Beijing,

China

Sipra Labs Limited

8 March, 2019 - 12 March, 2019

Hyderabad,

India

Sitec Labs Pvt Ltd

31 January, 2014 - 1 February, 2014

Navi Mumbai,

India

Sitec Labs Pvt Ltd

14 February, 2012 - 17 February, 2012

Mumbai,

India

SK Bioscience Co Ltd

20 May, 2019 - 24 May, 2019

Gyeongsangbuk-do,

Republic of Korea

SK Bioscience Co Ltd

7 May, 2018 - 11 May, 2018

Gyeongsangbuk-do,

Republic of Korea

Solara Active Pharma Sciences Limited - Desk Assessment

1 July, 2020

Chennai,

India

Spinos Life Science and Research Pvt Ltd

11 April, 2018 - 13 April, 2018

Tamil Nadu,

India

Square Pharmaceuticals Ltd (SPL)

18 May, 2015 - 20 May, 2015

Gazipur,

Bangladesh

ST Pharm Co Ltd (Sihwa site) - Desk Review

18 September, 2019 - 7 November, 2019

Gyeonggi-do,

Republic of Korea

Stabicon Life Sciences Pvt Ltd

10 September, 2013 - 12 September, 2013

Bangalore,

India

Stada Vietnam Joint Venture Co Ltd

15 August, 2011 - 19 August, 2011

Binh Duong Province,

Viet Nam

State Drug Administration of Ukraine, State Enterprise "Central Laboratory for Quality Control of Medicines and Medical Products"

10 May, 2016 - 11 May, 2016

Kyiv,

Ukraine

State Scientific Research Laboratory on Quality Control of Medicines

28 September, 2015 - 30 September, 2015

Kyiv,

Ukraine

Strides Arcolab Limited

13 December, 2010 - 14 December, 2010

Bangalore,

India

Strides Arcolab Ltd

19 October, 2013 - 22 October, 2013

Bangalore,

India

Strides Pharma Science Limited - Desk Review

28 October, 2019

Bangalore,

India

Strides Shasun Limited

24 October, 2016 - 26 October, 2016

Cuddalore,

India

Strides Shasun Ltd

13 June, 2016 - 17 June, 2016

Bangalore,

India

Suheung Co Ltd

8 April, 2019 - 12 April, 2019

Chungcheongbuk-Do,

Republic of Korea

Sun Pharmaceutical Industries Ltd

14 January, 2019 - 15 January, 2019

Vadodara,

India

Sun Pharmaceutical Industries Ltd

10 October, 2017 - 12 October, 2017

Paonta Sahib,

India

Sun Pharmaceutical Industries Ltd - Desk Review

18 May, 2020 - 21 May, 2020

Mumbai,

India

VCP

Sunshine World Net 2003 Co Ltd

19 September, 2018 - 20 September, 2018

Ratchaburi,

Thailand

Svizera Labs Private Limited

26 September, 2011 - 29 September, 2011

Navi Mumbai,

India

Svizera Labs Pvt Ltd

25 June, 2017 - 29 June, 2017

Navi Mumbai,

India

Swiss Pharma Nigeria Limited

15 April, 2011 - 17 April, 2011

Lagos,

Nigeria

Symed Labs Limited

19 October, 2015 - 21 October, 2015

Telangana,

India

Symed Labs Ltd - Unit I - Desk Review

26 November, 2018

Telangana,

India

Symed Labs Ltd - Unit II - Desk Review

6 May, 2019

Telangana,

India

Synchron Research Services (Pvt) Ltd

11 June, 2018 - 15 June, 2018

Ahmedabad,

India

Synchron Research Services (Pvt) Ltd

17 May, 2010

Ahmedabad,

India

Syneos Health Clinique Inc - Desk Review

3 June, 2019

Quebec & Montreal,

Canada

VCP

Tagros Chemicals India Pvt Ltd

21 May, 2018 - 22 May, 2018

Tamil Nadu,

India

Tanzania Food and Drug Authority Laboratory (TFDA), National Quality Control Laboratory

7 September, 2010 - 8 September, 2010

Dar Es Salaam,

United Republic of Tanzania

Technolog Private Joint Stock Company (Group of pharmaceutical companies Lekhim)

4 December, 2018 - 7 December, 2018

Uman city,

Ukraine

Testing Centre for Evaluation of Medical Products Quality of the Federal State Budgetary Institution "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of The Russian Federation (FSBI "SCEEMP")

16 May, 2016 - 20 May, 2016

Moscow,

Russian Federation

Testing Centre for Evaluation of Medicinal Products Quality of the Federal State Budgetary Institution "Scientific Centre for Expert Evaluation of Medicinal Products" of the Ministry of Health of the Russian Federation

23 September, 2015 - 25 September, 2015

Moscow,

Russian Federation

The Government Pharmaceutical Organization (GPO)

9 September, 2019 - 13 September, 2019

Pathumthani,

Thailand

The Government Pharmaceutical Organization (GPO)

30 May, 2017 - 2 June, 2017

Bangkok,

Thailand

The Jordanian Pharmaceuticals Manufacturing Company

17 May, 2015 - 20 May, 2015

Um Al-Amad,

Jordan

The State Expert Center, Ministry of Health of Ukraine

12 May, 2016 - 13 May, 2016

Kyiv,

Ukraine

The State Scientific Research Laboratory for Quality Control of Medicines

12 June, 2019 - 14 June, 2019

Kyiv,

Ukraine

VCP

Thio Chemi Pvt Ltd

17 May, 2018 - 18 May, 2018

Coimbatore,

India

VCP

Tianjin Yorkool International Trading Co Ltd

8 May, 2019 - 13 May, 2019

Baoding city,

China

VCP

TJC Chemical Co Ltd

17 September, 2018 - 18 September, 2018

Bangpoo-mai,

Thailand

VCP

Tropical Agro System India Pvt Ltd

14 May, 2018 - 15 May, 2018

Chennai,

India

TÜV SÜD PSB Pte Ltd

26 March, 2012 - 27 March, 2012

Singapore

TUV SUD PSB Pvt Ltd

24 October, 2016 - 26 October, 2016

Singapore

TÜV SÜD PSD Pte Ltd

1 December, 2014 - 2 December, 2014

Singapore,

Singapore

UAB Santonika

4 June, 2018 - 6 June, 2018

Kaunas,

Lithuania

United States Pharmacopoeia - Ghana

11 June, 2017 - 13 June, 2017

Accra,

Ghana

Universal Corporation Limited

27 August, 2018 - 30 August, 2018

Kikuyu Town,

Kenya

Universal Corporation Limited

29 May, 2017 - 1 June, 2017

Kikuyu Town,

Kenya

Universal Corporation Ltd

13 June, 2011 - 16 June, 2011

Kikuyu Town,

Kenya

University of Liège - Faculty of Medicines - Department of Pharmacy - Desk Review

6 March, 2019

Liège,

Belgium

VCP

V.K.A. Polymers Pvt Ltd

23 July, 2018 - 27 July, 2018

Tamil Nadu,

India

Veeda Clinical Research Pvt Ltd

14 February, 2013 - 18 February, 2013

Ahmedabad,

India

VerGO Pharma Research Pvt Ltd

16 April, 2018 - 19 April, 2018

Goa,

India

Vimta Labs Limited

20 December, 2010 - 22 December, 2010

Hyderabad,

India

Vimta Labs Ltd

21 August, 2013 - 23 August, 2013

Hyderabad,

India

Vimta Labs Ltd, Life Sciences Facility

13 March, 2019 - 15 March, 2019

Hyderabad,

India

VCP

Vinmos Company Limited

19 November, 2018 - 20 November, 2018

Duc Hoa Thuaong commune,

Viet Nam

Xinchang Pharmaceutical Factory, Zhejiang Medicine Co Ltd

20 June, 2012 - 22 June, 2012

Zhejiang Province,

China

IVD

Zephyr Biomedicals - Biomedicals – A division of Tulip Diagnostics (Pty) Ltd

23 January, 2019 - 25 January, 2019

Goa,

India

Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd

13 January, 2020 - 17 January, 2020

Zhejiang,

China

Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd

27 January, 2015 - 30 January, 2015

Zhejiang,

China

Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd

20 March, 2012 - 22 March, 2012

Zhejiang,

China

Zhejiang Apeloa Kangyu Pharmaceutical Co Ltd

13 January, 2020 - 17 January, 2020

Zhejiang,

China