WHO Product ID
RH035
Status
Prequalified
INN, dosage form and strength
Ethinylestradiol/Levonorgestrel Tablet, Sugar coated+Placebo Tablet, Film-coated 30µg/150µg+0mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Reproductive health
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated + Tablet, Sugar 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, Alu/PVdC/PVC
Configuration
28x1
Shelf life (months)
36
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
