Component APIs — where each ingredient comes from
11 verified API manufacturers
17 verified API manufacturers
Finished-combination manufacturers
Companies with a filed ethinylestradiol + levonorgestrel finished product. Approval reach is
reconciled against the FDA Orange Book, EMA and WHO-PQ.
Aurobindo Pharma Limited
IN
US ANDA/NDA (Orange Book) 206850
No US/EU/WHO combination approval matched — verified maker, national registration only.
Glenmark Pharmaceuticals S.R.O.
BR
US ANDA/NDA (Orange Book) 203163
US ANDA/NDA (Orange Book) 091467EU MA (EMA)WHO-PQ
Dr Reddy'S Laboratories Ltd
IN
No US/EU/WHO combination approval matched — verified maker, national registration only.
No US/EU/WHO combination approval matched — verified maker, national registration only.
No US/EU/WHO combination approval matched — verified maker, national registration only.
Jamp Pharma Corporation
—
No US/EU/WHO combination approval matched — verified maker, national registration only.
Viatris Farmaceutica Do Brasil Ltda
BR
No US/EU/WHO combination approval matched — verified maker, national registration only.
Teva Farmaceutica Ltda.
BR
No US/EU/WHO combination approval matched — verified maker, national registration only.