Medicines/finished pharmaceutical products

Reference Number: 
RH039

Date of prequalification: 
08 April 2014
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Misoprostol
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Tablet 200mcg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Blister Alu/Alu: 4x1, 4x7, 4x15
Applicant: 
Cipla Ltd, Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai, Maharashtra, 400 013, India
FPP Manufacturing Site: 

Cipla Ltd, Unit 8, 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: 

(Misoprostol Dispersion (1:100 in HPMC)) Piramal Healthcare UK Ltd, Whalton Road, Morpeth, Northumberland, NE61 3YA, United Kingdom of Great Britain and Northern Ireland

API WHO Public Inspection Reports: