Molecules / Pemetrexed Disodium 2.5-Hydrate

Pemetrexed Disodium 2.5-Hydrate API manufacturers

Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

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

Holds one valid CEP for pemetrexed disodium 2.5-hydrate, filing since 2024. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced EDQM certificate database
View profile
02

Laurus Labs

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

Holds one valid CEP for pemetrexed disodium 2.5-hydrate, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
How this listing is sourced EDQM certificate database
View profile
03

Synthon

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

Holds one valid CEP for pemetrexed disodium 2.5-hydrate, filing since 2024. Its GMP is recognised in 14 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
14 markets
How this listing is sourced EDQM certificate database
View profile
04

Shilpa Pharma Lifesciences

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

Holds one valid CEP for pemetrexed disodium 2.5-hydrate, filing since 2023. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
05

Suzhou Lixin Pharmaceutical

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

Holds one valid CEP for pemetrexed disodium 2.5-hydrate, filing since 2025. Its 2023 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
06

Shandong Anhong Pharmaceutical

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

Holds one valid CEP for pemetrexed disodium 2.5-hydrate, filing since 2022. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2019 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile

3 more manufacturers hold filings for pemetrexed disodium 2.5-hydrate

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

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

Map pemetrexed disodium 2.5-hydrate for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

Also on this molecule