Molecules / Amoxicillin

Amoxicillin API manufacturers

CAS 26787-78-0 ATC J01CA04 Updated 9 July 2026
22
manufacturers with an active filing 15 of them hold a US DMF or a CEP
$29.81
median export price per kg $28.00 to $34.39 · 39 exporters · 2025
254
shortage records on file across 15 countries
1,955
finished-dose makers across 54 regulators
Showing 20 of 22 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Sandoz

Switzerland
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF and 3 valid CEPs for amoxicillin, filing since 2023. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
3 valid
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
04

Fresenius Kabi Ab

Sweden
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for amoxicillin, filing since 2023. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 48 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
48 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Teva

Israel
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for amoxicillin, filing since 1998. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 42 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
42 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Antibioticos Do Brasil Ltda

Brazil
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for amoxicillin, filing since 1998. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 5 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Acs Dobfar

Italy
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for amoxicillin, filing since 2009. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 12 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
12 markets
How this listing is sourced EDQM certificate database
View profile
09

Apitoria Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 3 active US DMFs and 3 valid CEPs for amoxicillin, filing since 2005. Its 2025 FDA inspection closed as VAI.

US DMF
3 active
CEP
3 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Antibioticos De Leon Slu

Spain
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for amoxicillin, filing since 2016.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Fersinsa Gb Sa De Cv

Mexico
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for amoxicillin, filing since 2017.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Deretil

Spain
Makes the API

Registered with SFDA (Saudi Arabia) for amoxicillin. Its 2023 FDA inspection closed as VAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
17

Dsm Anti Infectives

Netherlands
Makes the API

Registered with SFDA (Saudi Arabia) for amoxicillin.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

Registered with SFDA (Saudi Arabia) for amoxicillin. Its 2017 FDA inspection closed as VAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2017 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
19

M/s. Punjab

India
Makes the API

Registered with SFDA (Saudi Arabia) for amoxicillin.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
20

Registered with SFDA (Saudi Arabia) for amoxicillin.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators
Price band
Customs export unit values for 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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Export price by year

Year Median Exporters
2025 $29.81 39
2024 $32.70 45
2023 $35.59 55
2022 $35.59 41

US dollars per kilogram, customs export unit values.