Medicines/finished pharmaceutical products

Reference Number: 
RH061 (a)

Date of prequalification: 
23 May 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Mifepristone
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Tablet 200mg
Storage condition: 
SRA accepted: This medicinal product does not require any special storage conditions; WHO recommended: Do not store above 25⁰C. Store in the original package. The shelf life at this storage condition is 48 months.
Shelf life (months): 
48
Packaging: 
Blister;Alu/PVC 1x1;3x1;15x1;30x1
Applicant: 
Exelgyn, 216 BOULEVARD SAINT GERMAIN, Paris, 75007, France
FPP Manufacturing Site: 

Laboratoires MACORS, Z.I Plaine des Isles, Rue des Caillottes, Auxerre, 89000, France

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Mifepristone) Expansia, Route d'Avignon F-30390, Aramon, France
(Mifepristone) VLG CHEM, 35, avenue Jean Jaurès, Villeneuve-La-Garenne, F-92390, France
(Mifepristone) Indo Phyto Chemicals Pvt Ltd, API Block, Shakhanpur, Kashipur, Ramnagar (M), Nainital District, Uttarakhand, 244 715, India

API WHO Public Inspection Reports: