Product Details
WHO Product ID
RH013
Status
Prequalified
INN, dosage form and strength
Ethinylestradiol/Levonorgestrel Tablet, coated 30mcg/150mcg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet, coated
Applicant organization
Senador Laboratories Private Limited
Plot 2B & 2C, Biotech Park, Phase II, Lalgadi Malakpet, Medchal Malkajgiri
Hyderabad,
Telangana
500101
India
Packaging details and storage conditions
Packaging Type
Blister, Al/PVdC/PVC
Configuration
21x1, 21x3, 21x6, 21x13, 21x100
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Bayer AG
Bergkamen Plant, Ernst Schering Strasse 14
Bergkamen,
59192
Germany
Ethinylestradiol, Levonorgestrel
Bayer AG
Charlottenburg Plant, Max-Dohrn-Strasse 8
Berlin,
10589
Germany
Ethinylestradiol, Levonorgestrel
Industriale Chimica S.R.L
E. H. Grieg 13, Saronno
Varese,
21047
Italy
Levonorgestrel
FPP Manufacturing Site(s)
Senador Laboratories Private Limited
Plot No 20 & 21, Pharmez Sarkhej-Bavla National Highway No. 8A, Near Village Matoda, Taluka: Sanad
Dist. Ahmedabad,
Gujarat
382 213
India
Senador Laboratories Private Limited
Plot No. 1606-1609, G. I. D.C. Sarigam, Dist. Valsad
Gujarat
396155
India