Component APIs — where each ingredient comes from
11 verified API manufacturers
11 verified API manufacturers
Finished-combination manufacturers
Companies with a filed drospirenone + ethinylestradiol finished product. Approval reach is
reconciled against the FDA Orange Book, EMA and WHO-PQ.
Aurobindo Pharma Limited
IN
US ANDA/NDA (Orange Book) 209632
Viatris Farmaceutica Do Brasil Ltda
BR
No US/EU/WHO combination approval matched — verified maker, national registration only.
US ANDA/NDA (Orange Book) 022532EU MA (EMA)
US ANDA/NDA (Orange Book) 205876
Teva Farmaceutica Ltda.
BR
EU MA (EMA)
Glenmark Pharmaceuticals S.R.O.
BR
US ANDA/NDA (Orange Book) 204296
US ANDA/NDA (Orange Book) 205947EU MA (EMA)