Molecules / Ampicillin

Ampicillin API manufacturers

CAS 69-53-4 ATC J01CA01 Updated 9 July 2026
21
manufacturers with an active filing 15 of them hold a US DMF or a CEP
$40.52
median export price per kg $33.00 to $101.02 · 30 exporters · 2025
57
shortage records on file across 9 countries
832
finished-dose makers across 47 regulators
Showing 20 of 21 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Acs Dobfar

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

Holds 8 active US DMFs and one valid CEP for ampicillin, filing since 1998. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 12 markets.

US DMF
8 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
12 markets
05

Fresenius Kabi Ab

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

Holds 3 active US DMFs for ampicillin, filing since 2009. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 48 markets.

US DMF
3 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
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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 ampicillin, 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
08

Apitoria Pharma

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

Holds 4 active US DMFs and 4 valid CEPs for ampicillin, filing since 2006. Its 2025 FDA inspection closed as VAI.

US DMF
4 active
CEP
4 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Sterile India

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

Holds one active US DMF for ampicillin, filing since 2018. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Adl Biopharma Slu

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

Holds one active US DMF for ampicillin, 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 2 active US DMFs for ampicillin, filing since 1998.

US DMF
2 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

Imexpharm

Vietnam
Makes the API

Registered with DAV (Vietnam) for ampicillin. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
18

Mekophar Chemical Pharmaceutical

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for ampicillin. Its GMP is recognised in 2 markets.

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

Thanh

Makes the API

Registered with DAV (Vietnam) for ampicillin. Its GMP is recognised in 2 markets.

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

Bidiphar - Dược Bình Định

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for ampicillin. Its GMP is recognised in 1 market.

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

Contract manufacturers (4)

Contract manufacturers make to order rather than holding their own filing for this molecule.

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 $40.52 30
2024 $53.51 33
2023 $54.52 45
2022 $42.85 38

US dollars per kilogram, customs export unit values.