Component APIs — where each ingredient comes from
20 verified API manufacturers
20 verified API manufacturers
Finished-combination manufacturers
Companies with a filed atorvastatin + amlodipine finished product. Approval reach is
reconciled against the FDA Orange Book, EMA and WHO-PQ.
Alembic Pharmaceuticals Limited
US
US ANDA/NDA (Orange Book) 217279
No US/EU/WHO combination approval matched — verified maker, national registration only.
US ANDA/NDA (Orange Book) 205199
Viatris Farmaceutica Do Brasil Ltda
BR
No US/EU/WHO combination approval matched — verified maker, national registration only.
Dr Reddy'S Laboratories Ltd
IN
No US/EU/WHO combination approval matched — verified maker, national registration only.