Molecules / Epirubicin

Epirubicin API manufacturers

CAS 56420-45-2 ATC L01DB03 Updated 9 July 2026
7
manufacturers with an active filing 6 of them hold a US DMF or a CEP
29
shortage records on file across 9 countries
268
finished-dose makers across 42 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Shandong New Time Pharmaceutical

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

Holds 2 active US DMFs for epirubicin, filing since 2006. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
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03

Olon

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

Holds one valid CEP for epirubicin, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
How this listing is sourced EDQM certificate database
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04

MicroBiopharm Japan

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

Holds one active US DMF for epirubicin, filing since 2008. Its 2026 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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05

Synbias Pharma

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

Holds one active US DMF for epirubicin, filing since 2002.

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
06

Zhejiang Hisun Pharmaceutical

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

Holds one valid CEP for epirubicin, filing since 2024. 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
07

Bidiphar - Dược Bình Định

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for epirubicin. 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
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4 more manufacturers hold filings for epirubicin

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

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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

Who makes epirubicin?

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

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