Medicines/finished pharmaceutical products

Reference Number: 
HA396 *

Date of prequalification: 
25 July 2008
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Nevirapine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet 200mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
60
Packaging: 
Bottle HDPE: 60x1; 56x1, Blister Alu/PVC: 10x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

Mylan Laboratories Ltd, Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector III, Pithampur, District Dhar, Madya Pradesh, 454 775, India
Mylan Laboratories Ltd, F4 & F12 Malegaon MIDC, Sinnar, Nashik District, Maharashtra, 422 113, India
Mylan Laboratories Ltd, Plot No H-12 & H13 MIDC Waluj Industrial Area, Aurangabad, Maharashtra, 431 136, India

API Manufacturing Site: 

(Nevirapine) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(Nevirapine) Hetero Drugs Limited, Unit 9, Plot 2, Hetero Infrastructure SEZ - Ltd, N Narasapuram Village, Nakkapalli Mandal, Visakhapatnam District, Andhra Pradesh, 531 081, India
(Nevirapine) Mylan Laboratories Ltd, Unit 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Sangareddy, Telangana, 502 319, India
(Nevirapine) Mylan Laboratories Limited, Unit 2, Survey No. 10/42, Gaddapotharam, Kazipally Industrial Area, Medak District, Telangana, 502 319, India
(Nevirapine) Zhejiang Huahai Pharmaceutical Co Ltd, Chuannan Site No.1 Branch Factory, Costal Industrial Zone, Duqiao, Linhai, Zhejiang, 317 016, China (People's Republic of)