Medicines/finished pharmaceutical products

Reference Number: 
RH056

Date of prequalification: 
27 April 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, protect from light
Shelf life (months): 
24
Packaging: 
Blister, Alu/Alu 10x10
Applicant: 
Acme Formulation Pvt. Limited, Hormone Block, Ropar Road, Nalagarh, Distt. Solan, Himachal Pradesh, 174101, India
FPP Manufacturing Site: 

Acme Formulation Pvt. Limited, Hormone Block, Ropar Road, Nalagarh, Distt. Solan, Himachal Pradesh, 174101, 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: