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HA702

Product Details
WHO Product ID
HA702
Status
Prequalified
INN, dosage form and strength
Dolutegravir (sodium)/Lamivudine/Tenofovir disoproxil fumarate Tablet, Film-coated 50mg/300mg/300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Cipla Ltd
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel
Mumbai,
Maharashtra
400 013
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE
Configuration
30x1; 90x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
Packaging Type
Bottle, HDPE
Configuration
28x1, 84x1, 180x1, 500x1
Shelf life (months)
24
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
Cipla Ltd
Plot D-22 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District
Maharashtra
413 802
India
Dolutegravir (sodium), Tenofovir disoproxil fumarate
Cipla Ltd
Plot D-27 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District
Maharashtra
413 802
India
Tenofovir disoproxil fumarate
Cipla Ltd
Plot D-7 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District
Maharashtra
413 802
India
Tenofovir disoproxil fumarate
Hetero Labs Limited
Unit IX, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Anakapalli District
Andhra Pradesh
531 081
India
Lamivudine
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India
Dolutegravir (sodium), Tenofovir disoproxil fumarate
Laurus Labs Limited
Unit 3, Plot No 18, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531 021
India
Lamivudine, Tenofovir disoproxil fumarate
Shanghai Desano Chemical Pharmaceutical Co. Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201 302
China
Dolutegravir (sodium), Lamivudine, Tenofovir disoproxil fumarate
FPP Manufacturing Site(s)
Cipla Limited
Unit VII PD II, Plot No. L-139, S-103 & M-62, Verna Industrial Area, Verna
Salcette,
Goa
403 722
India
Cipla Ltd
Unit 7, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette
Goa
403 722
India
Cipla Quality Chemical Industries Ltd
PO Box 34871, Plot No 1-7 Ring Road, Luzira Industrial Park
Kampala,
Uganda
WHO Public Assessment Reports


Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
Part 3 - WHO-PQ recommended patient information leaflet*
Part 4 - WHO-PQ recommended summary of product characteristics*
Part 5 - Label
Part 6 - Discussion (status at the time of prequalification)
Part 7 - Steps before Prequalification
Part 8 - Steps following Prequalification (from 01 March 2014, only changes to the published information are included)

* This summary of product characteristics/patient information leaflet focus on uses of the medicine covered by WHO Prequalification Team - Medicines. The recommendations for use are based on WHO guidelines and on information from stringent regulatory authorities (term to be revised). The medicine may be authorised for additional or different uses by national medicines regulatory authorities. 

Part 1 , Part 2 , Part 3 , Part 4 , Part 5 , Part 6 , Part 7 , Part 8

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