药品/药物成品

Reference Number: 
HA570

Date of prequalification: 
19 February 2014
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 months for HDPE bottle Pack; 48 months for blister pack
Packaging: 
Blister Alu/PVC/PVdC: 10x1; Bottle HDPE: 60x1
Applicant: 
Micro Labs Ltd, 31 Race Course Road, Bangalore, Karnataka, 560 001, India
FPP Manufacturing Site: 

Micro Labs Ltd, Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate, Verna, Goa, 403 722, India

API Manufacturing Site: 

(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) Shanghai Desano Chemical Pharmaceutical Co Ltd, 417 Binhai Road, Laogang Town, Pudong New Area, Shanghai, 201 302, China (People's Republic of)
(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)
(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