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HA729

Product Details
WHO Product ID
HA729
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
Strides Pharma Science Limited
Strides house, Opp. IIMB, Bilekahali, Bannerghatta Road
Bangalore,
Karnataka
560 076
India
Packaging details and storage conditions
Packaging Type
Bottle, HDPE with PP screw cap and molecular sieve canister
Configuration
28x1, 30x1, 56x1, 60x1, 84x1, 90x1, 168x1, 180x1
Shelf life (months)
36
Storage conditions
Do not store above 30°C
API Manufacturing Site(s)
By Organization
By Active Ingredient
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
Dolutegravir (sodium), Lamivudine, Tenofovir disoproxil fumarate
Shanghai Desano Chemical Pharmaceutical Co. Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Dolutegravir (sodium), Lamivudine, Tenofovir disoproxil fumarate
Shijiazhuang Lonzeal Pharmaceuticals Co Ltd
Workshop No.303, 104, 101 and 102, No.16 West Ring Road, Shenze
Shijiazhuang,
Hebei
52560
China
Lamivudine, Tenofovir disoproxil fumarate
Shilpa Medicare Limited
Plot Nos. 33, 33A, 40 to 47, Raichur Industrial Growth Centre, Wadloor Road, Chicksugur Cross, Chicksugur
Raichur,
Karnataka
584 134
India
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
Strides Pharma Science Limited
Unit II, RS No 32-34, PIMS Road, Periyakalapet
Puducherry
605 014
India
Universal Corporation Ltd
PO Box 1748, Club Road, Plot No 13777
Kikuyu,
902
Kenya
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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