Medicines/finished pharmaceutical products

Reference Number: 
RH044 (a)

Date of prequalification: 
21 October 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Desogestrel/Ethinylestradiol + Placebo
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Desogestrel/Ethinylestradiol Tablet + Placebo Tablet 150mcg/30mcg + 0mg
Storage condition: 
Do not store above 30°C
Shelf life (months): 
36
Packaging: 
Blister PVC-pouch: (21+7)x3
Applicant: 
Lupin Ltd, Kalpataru Inspire, 3rd Floor, Off Western Express Highway, Santacruz (East), Mumbai, Maharashtra, 400055, India
FPP Manufacturing Site: 

Lupin Ltd, Unit 1, Plot No 2, Special Economic Zone, Phase II SEZ, Pithampur, District Dhar, Madhya Pradesh, 454 775, India

FPP WHO Public Inspection Reports: 
API Manufacturing Site: 

(Desogestrel) Lupin Limited, Unit 1, Plot No 2, Special Economic Zone, Phase II SEZ, Pithampur, District Dhar, Madhya Pradesh, 454 775, India
(Ethinylestradiol) Lupin Limited, Unit 1, Plot No 2, Special Economic Zone, Phase II SEZ, Pithampur, District Dhar, Madhya Pradesh, 454 775, India

API WHO Public Inspection Reports: