Molecules / Combinations / Amoxicillin + Clavulanic Acid

Amoxicillin + Clavulanic Acid FDC suppliers and manufacturers

2-API combination Reference: Amoxicillin And Clavulanate Potassium Updated 29 July 2026
2
active pharmaceutical ingredientseach with its own verified maker list
8
finished-combination makers5 with a matched US/EU/WHO approval
Common ratios: 875/125500/125400/57200/28600/43250/62

Component APIs — where each ingredient comes from

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)

Hikma Italia Spa

IT
No US/EU/WHO combination approval matched — verified maker, national registration only.

Usantibiotics, Llc

US
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.

Micro Labs Limited

IN
US ANDA/NDA (Orange Book) 217805EU MA (EMA)

Sandoz, Inc.

US
US ANDA/NDA (Orange Book) 065066EU MA (EMA)

Cipla Ltd.

IN
US ANDA/NDA (Orange Book) 065431

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