药品/药物成品

Reference Number: 
RH041 (a)

Date of prequalification: 
26 August 2013
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Ethinylestradiol/Levonorgestrel + Placebo
Therapeutic area: 
Reproductive Health
Dosage form & strength: 
Ethinylestradiol/Levonorgestrel Tablet + Placebo Tablet 0.03mg/0.15mg + 0mg
Storage condition: 
Do not store above 25°C
Shelf life (months): 
24
Packaging: 
Blister PVC/Aclar: (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: 

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