Component APIs — where each ingredient comes from
5 verified API manufacturers
11 verified API manufacturers
Finished-combination manufacturers
Companies with a filed norgestimate + ethinylestradiol finished product. Approval reach is
reconciled against the FDA Orange Book, EMA and WHO-PQ.
No US/EU/WHO combination approval matched — verified maker, national registration only.
Amneal Pharmaceuticals Ny Llc
US
No US/EU/WHO combination approval matched — verified maker, national registration only.
Glenmark Pharmaceuticals S.R.O.
BR
US ANDA/NDA (Orange Book) 200494
US ANDA/NDA (Orange Book) 205588