Medicines/finished pharmaceutical products

Reference Number: 
HA518

Date of prequalification: 
08 January 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Abacavir (sulfate)/Lamivudine
Therapeutic area: 
HIV/AIDS
Dosage form & strength: 
Tablet, Dispersible 60mg/30mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Bottle HDPE: 60x1, 120x1
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla Ltd, Unit 7, Plot No L-139 to L-147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Verna Industrial Estate, Salcette, Goa, 403 722, India
Cipla, Unit 2, Plot A-42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India
Cipla Ltd, Unit 1, Plot A-33 & A-2 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India

API Manufacturing Site: 

(Abacavir (sulfate)) Mylan Laboratories Ltd, Unit 8, G Chodavaram Village, Poosapatirega Mandal, Viyianagaram District, Andhra Pradesh, 535 204, India
(Lamivudine) Cipla Ltd, Plot D-22 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India
(Lamivudine) Cipla Ltd, Plot D-7 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India
(Lamivudine) Cipla Ltd, Unit 1, Plot A-33 & A-2 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220, India