Molecules / Leucovorin

Leucovorin API manufacturers

CAS 1492-18-8 ATC V03AF03 Updated 9 July 2026
7
manufacturers with an active filing 6 of them hold a US DMF or a CEP
21
shortage records on file across 2 countries
219
finished-dose makers across 32 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Huzhou Zhanwang Pharmaceutical

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

Holds one active US DMF for leucovorin, filing since 2023. 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
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03

Cerbios-Pharma

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

Holds 2 active US DMFs for leucovorin, filing since 1983. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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04

Sichuan Huiyu Pharmaceutical

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

Holds one active US DMF for leucovorin, filing since 2024. Its GMP is recognised in 5 markets.

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

GMT Fine Chemicals

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

Holds 2 active US DMFs for leucovorin, filing since 2011. Its 2024 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Merck And Cie Kmg

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

Holds 2 active US DMFs for leucovorin, filing since 1984. Its 2023 FDA inspection closed as VAI.

US DMF
2 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
07

Nanogen

Vietnam
Makes the API

Registered with DAV (Vietnam) for leucovorin. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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4 more manufacturers hold filings for leucovorin

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Sichuan Huiyu PharmaceuticalGMT Fine ChemicalsMerck And Cie KmgNanogen
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Finished-dose makers (41)

Fresenius Kabi Ab Sweden Amneal United States Dr. Reddy's Laboratories India Glenmark Pharmaceuticals s.r.o Czech Republic HIKMA ITALIA Italy Teva Israel Viatris United States Epic Pharma United States Hospira United States Hainan Poly Pharm China Zentiva, k.s Czech Republic Gsk Vaccines United Kingdom Leading Pharma United States Medac Gesellschaft für klinische Spezialpräparate mbH; Germany Pfizer Brasil Ltda Brazil Sandoz Switzerland Ingenus Pharmaceuticals United States Pharmaniaga Lifescience Malaysia Pt Fonko International Pharmaceuticals Indonesia AlfaSigma Italy

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

Who makes leucovorin?

Ask Fred which manufacturers are on record for leucovorin and what filings they hold.

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Also on this molecule

Shortages 21 Recalls 8 Finished dose 41 Contract mfrs 0