Molecules / Fosfomycin

Fosfomycin API manufacturers

CAS 23155-02-4 ATC J01XX01 Updated 9 July 2026
13
manufacturers with an active filing 9 of them hold a US DMF or a CEP
$169.79
median export price per kg $141.39 to $227.50 · 11 exporters · 2024
10
shortage records on file across 8 countries
361
finished-dose makers across 49 regulators
Showing 13 of 13 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Ercros

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

Holds 3 active US DMFs and one valid CEP for fosfomycin, filing since 1995. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
3 active
CEP
1 valid
Last FDA inspection
2018 · VAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for fosfomycin, filing since 1994. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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04

Quimica Sintetica

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

Holds one active US DMF for fosfomycin, filing since 2018. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Honour Lab

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

Holds 3 active US DMFs for fosfomycin, filing since 2024. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
3 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

MSN Laboratories

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

Holds 2 active US DMFs for fosfomycin, filing since 2024. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Zach System

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

Holds one valid CEP for fosfomycin, filing since 2025. Its 2021 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2021 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
08

Interquim

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

Holds one active US DMF for fosfomycin, 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
09

Clarochem Ireland

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

Holds one valid CEP for fosfomycin, filing since 2025. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
10

Công ty Cổ phần Dược phẩm CPC1 Hà Nội

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for fosfomycin. 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

Meyer Bpc Joint Venture

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for fosfomycin. 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

Registered with DAV (Vietnam) for fosfomycin. 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
13

Công ty Cổ phần Nam Dược

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for fosfomycin. 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

10 more manufacturers hold filings for fosfomycin

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Open the full list with a free account

Contract manufacturers (7)

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 2024. 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
2024 $169.79 11
2023 $193.12 8
2022 $195.43 7

US dollars per kilogram, customs export unit values.