Component APIs — where each ingredient comes from
20 verified API manufacturers
5 verified API manufacturers
Finished-combination manufacturers
Companies with a filed amoxicillin + clavulanic acid finished product. Approval reach is
reconciled against the FDA Orange Book, EMA and WHO-PQ.
Aurobindo Pharma Limited
IN
US ANDA/NDA (Orange Book) 209371EU MA (EMA)
No US/EU/WHO combination approval matched — verified maker, national registration only.
No US/EU/WHO combination approval matched — verified maker, national registration only.
Sandoz Canada Incorporated
CA
US ANDA/NDA (Orange Book) 065066EU MA (EMA)
Jamp Pharma Corporation
—
No US/EU/WHO combination approval matched — verified maker, national registration only.
US ANDA/NDA (Orange Book) 217805EU MA (EMA)
US ANDA/NDA (Orange Book) 065066EU MA (EMA)
US ANDA/NDA (Orange Book) 065431