Molecules / Combinations / Drospirenone + Ethinylestradiol

Drospirenone + Ethinylestradiol FDC suppliers and manufacturers

2-API combination Reference: Drospirenona + Etinilestradiol Updated 29 July 2026
2
active pharmaceutical ingredientseach with its own verified maker list
7
finished-combination makers6 with a matched US/EU/WHO approval
Common ratios: 0/03/00/3

Component APIs — where each ingredient comes from

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.

Bayer S.A.

BR
US ANDA/NDA (Orange Book) 022532EU MA (EMA)

Apotex Inc.

CA
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

Lupin Limited

IN
US ANDA/NDA (Orange Book) 205947EU MA (EMA)

Have a question like this?

Tell Fred what you're working on and ask which records can help.

Chat with Fred, your AI analyst
Opens WhatsApp. Free to start.

Component molecule pages