Molecules / Micafungin

Micafungin API manufacturers

CAS 235114-32-6 ATC J02AX05 Updated 9 July 2026
8
manufacturers with an active filing 7 of them hold a US DMF or a CEP
7
shortage records on file across 2 countries
196
finished-dose makers across 33 regulators
Showing 8 of 8 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Biocon

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

Holds one active US DMF for micafungin, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
29 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

MSN Laboratories

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

Holds one active US DMF for micafungin, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

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

Hetero

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

Holds 2 active US DMFs for micafungin, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for micafungin, filing since 2018. Its GMP is recognised in 4 markets.

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

Medichem Manufacturing (Malta)

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

Holds one active US DMF for micafungin, filing since 2016. Its 2018 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06

BrightGene Bio-Medical Technology

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

Holds 3 active US DMFs for micafungin, filing since 2015. Its GMP is recognised in 1 market.

US DMF
3 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Yung Shin Pharmaceutical Ind

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

Holds one active US DMF for micafungin, filing since 2020. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Registered with SFDA (Saudi Arabia) for micafungin. 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

5 more manufacturers hold filings for micafungin

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 (3)

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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