Medicines/finished pharmaceutical products

Reference Number: 
HA371 *

Date of prequalification: 
23 April 2008
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Abacavir (sulfate)
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet 300mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle HDPE: 60x1
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla Ltd, Unit 1, Plot A-33 & A-2 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India
Cipla, Unit 2, Plot A-42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India

API Manufacturing Site: 

(Abacavir (sulfate)) Cipla Ltd, Plot D-22 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India
(Abacavir (sulfate)) Mylan Laboratories Ltd, Unit 8, G Chodavaram Village, Poosapatirega Mandal, Viyianagaram District, Andhra Pradesh, 535 204, India