Component APIs — where each ingredient comes from
9 verified API manufacturers
13 verified API manufacturers
Finished-combination manufacturers
Companies with a filed brimonidine + timolol finished product. Approval reach is
reconciled against the FDA Orange Book, EMA and WHO-PQ.
Caplin Steriles Limited
IN
US ANDA/NDA (Orange Book) 219093
US ANDA/NDA (Orange Book) 091087
US ANDA/NDA (Orange Book) 021398EU MA (EMA)
Alembic Pharmaceuticals Limited
US
US ANDA/NDA (Orange Book) 215230
Jamp Pharma Corporation
—
No US/EU/WHO combination approval matched — verified maker, national registration only.
Glenmark Pharmaceuticals S.R.O.
BR
US ANDA/NDA (Orange Book) 214987
US ANDA/NDA (Orange Book) 091442