Component APIs — where each ingredient comes from
13 verified API manufacturers
13 verified API manufacturers
Finished-combination manufacturers
Companies with a filed dorzolamide + timolol finished product. Approval reach is
reconciled against the FDA Orange Book, EMA and WHO-PQ.
Aurobindo Pharma Limited
IN
EU MA (EMA)
Sandoz Canada Incorporated
CA
US ANDA/NDA (Orange Book) 078749EU MA (EMA)
Alembic Pharmaceuticals Limited
US
US ANDA/NDA (Orange Book) 213099
Gland Pharma Limited.,
US
US ANDA/NDA (Orange Book) 215520
No US/EU/WHO combination approval matched — verified maker, national registration only.
Ingenus Pharmaceuticals, Llc
US
US ANDA/NDA (Orange Book) 217260
No US/EU/WHO combination approval matched — verified maker, national registration only.
Laboratoire Riva Incorporated
—
No US/EU/WHO combination approval matched — verified maker, national registration only.