Medicines/finished pharmaceutical products

Reference Number: 
RH048

Date of prequalification: 
22 November 2016
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: 
Alu/Alu Blister 3x1, 4x1
Applicant: 
China Resources Zizhu Pharmaceutical Co Ltd, No 27 Chaoyang North Road, Chaoyang District, Beijing, 100024, China (People's Republic of)
FPP Manufacturing Site: 

China Resources Zizhu Pharmaceutical Co Ltd, No 27 Chaoyang North Road, Chaoyang District, Beijing, 100024, China (People's Republic of)

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: