Medicines/finished pharmaceutical products

Reference Number: 
IN010

Date of prequalification: 
13 June 2014
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): 
Bottle HDPE and Blister Alu/PVC/PE/PVdC - 24, Blister Alu/PVC - 18
Packaging: 
Bottle HDPE: 30x1; Blister Alu/PVC: 10x1; Blister Alu/PVC/PE/PVdC: 10x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500034, India
FPP Manufacturing Site: 

Mylan Laboratories Ltd, Plot No H-12 & H13 MIDC Waluj Industrial Area, Aurangabad, Maharashtra, 431 136, India

API Manufacturing Site: 

(Oseltamivir (phosphate)) Mylan Laboratories Ltd, Unit 1, Survey 10/42, Gaddapotharam, Kazipally Industrial Area, Medak District, Andhra Pradesh, 502 319, India