Molecules / Gentamicin

Gentamicin API manufacturers

CAS 1403-66-3 Updated 9 July 2026
11
manufacturers with an active filing 4 of them hold a US DMF or a CEP
57
shortage records on file across 17 countries
1,000
finished-dose makers across 50 regulators
Showing 11 of 11 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Acs Dobfar

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

Holds 4 active US DMFs for gentamicin, filing since 2010. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 12 markets.

US DMF
4 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
12 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Fujian Fukang Pharmaceutical

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

Holds one active US DMF for gentamicin, filing since 1996. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for gentamicin, filing since 2016. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Fresenius Kabi Ab

Sweden
Makes the APIFinished dose

Registered with DAV (Vietnam) for gentamicin. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 48 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
48 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
06

Registered with SFDA (Saudi Arabia) for gentamicin. 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
07

Bidiphar - Dược Bình Định

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for gentamicin. 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

Registered with DAV (Vietnam) for gentamicin. 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
09

Công ty cổ phần Dược phẩm An Thiên

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for gentamicin. 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

Registered with DAV (Vietnam) for gentamicin. 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
11

Pharmedic S A

Vietnam
Makes the API

Registered with DAV (Vietnam) for gentamicin. 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

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