Medicines/finished pharmaceutical products

Reference Number: 
RH037 (a)

Date of prequalification: 
14 August 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Desogestrel/Ethinylestradiol
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Tablet 0.150mg/0.030mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
24
Packaging: 
Blister Al/PVC/PVdC: 21x1
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: 

(Desogestrel) Industriale Chimica s.r.l., Via E. H. Grieg 13, 21047, Saronno (Varese), Italy
(Ethinylestradiol) Aspen Oss B.V., Site De Geer, Veersemeer 4, JN OSS, 5347 JN, Netherlands
(Desogestrel) Aspen Oss B.V., Site De Geer, Veersemeer 4, JN OSS, 5347 JN, Netherlands
(Desogestrel) Aspen Oss B.V., Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands
(Ethinylestradiol) Aspen Oss B.V., Kloosterstraat 6, Moleneind, AB Oss, 5349 AB, Netherlands

API WHO Public Inspection Reports: