Medicines/finished pharmaceutical products

Reference Number: 
RH032

Date of prequalification: 
14 June 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Levonorgestrel
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Tablet 750mcg
Storage condition: 
Do not store above 30°C, protect from light
Shelf life (months): 
24
Packaging: 
Blister Alu/PVdC/PVC: 2x1
Applicant: 
Mylan Laboratories Ltd, Plot No.564/A/22, Road No. 92, Jubilee Hills, Hyderabad, Telangana, 500096, India
FPP Manufacturing Site: 

Mylan Laboratories Limited, Sarkhej- Bavla NH No- 8A, Plot No 20/21 Pharmaceutical Special Economic Zone, Nr Village Matoda, Ahmedabad, Gujarat, 382213, India

API Manufacturing Site: 

(Levonorgestrel) Bayer AG, Bergkamen Plant, Ernst Schering Strasse 14, Bergkamen, 59192, Germany
(Levonorgestrel) Bayer AG, Charlottenburg Plant, Max-Dohrn-Strasse 8, Berlin, 10589, Germany

API WHO Public Inspection Reports: