Medicines/finished pharmaceutical products

Reference Number: 
IN013

Date of prequalification: 
10 February 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Oseltamivir (phosphate)
Therapeutic area: 
Influenza
Dosage form & strength: 
Capsules, hard 45mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Blister,Alu/PVC-PVdC 10x1; Bottle,HDPE 30x1
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

API Manufacturing Site: 

(Oseltamivir (phosphate)) Cipla Ltd, Plot D-22 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India
(Oseltamivir (phosphate)) Cipla Ltd, Plot D-7 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune District, Maharashtra, 413 802, India

API WHO Public Inspection Reports: