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HA552

Product Details
WHO Product ID
HA552
Status
Prequalified
INN, dosage form and strength
Emtricitabine/Tenofovir disoproxil fumarate Tablet, Film-coated 200mg/300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
HIV/AIDS
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Strides Pharma Science Limited
Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road
Bangalore,
Karnataka
560 076
India
Packaging details and storage conditions
Packaging Type
Container, HDPE
Configuration
30x1
Shelf life (months)
24
API Manufacturing Site(s)
By Organization
By Active Ingredient
Acebright (India) Pharma Pvt Ltd
77D & 116/117 KIADB Industrial Area, Jigani
Bangalore,
Karnataka
560 105
India
Tenofovir disoproxil fumarate
Laurus Labs Limited
Unit-4, Plot No.25, 25A to 25K, APSEZ De-Notified Area, Lalamkoduru Village, Rambilli Mandal
Anakapalli,
Andhra Pradesh
531011
India
Tenofovir disoproxil fumarate
Laurus Labs Limited
Unit 1, Plot No 21, Jawaharlal Nehru Pharma City, Anakapalli District
Parawada,
Andhra Pradesh
531 021
India
Tenofovir disoproxil fumarate
Laurus Labs Limited
Unit 3, Plot No 18, Jawaharlal Nehru Pharma City, Parawada
Anakapalli,
Andhra Pradesh
531 021
India
Emtricitabine, Tenofovir disoproxil fumarate
Mylan Laboratories Limited (Unit-10)
Plot No. 86, Ramky Pharma City (India) Ltd, Parawada Mandal, Anakapalli District
JN Pharma City,
Andhra Pradesh
531019
India
Tenofovir disoproxil fumarate
Mylan Laboratories Ltd
Unit 8, G Chodavaram, Poosapatirega Mandal, Vizianagaram District
Andhra Pradesh
535 204
India
Tenofovir disoproxil fumarate
Mylan Laboratories Ltd
Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Tadi Village, Parawada (M), Anakapalli District
Andhra Pradesh
531019
India
Emtricitabine
Shanghai Desano Chemical Pharmaceutical Co Ltd
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201 302
China
Tenofovir disoproxil fumarate
FPP Manufacturing Site(s)
Strides Pharma Science Limited
Oral Solid Dosage Forms Division, KRS Gardens, 36/7, Suragajakkanahalli, Indlawadi Cross, Anekal Taluk
Bangalore,
Karnataka
562 106
India
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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