Micafungin API manufacturers

Micafungin is a cyclic lipopeptide echinocandin antifungal (Mycamine).

5 listed companies hold an active US Type II Drug Master File for Micafungin API, based in India (3), Netherlands (1), China (1). 3 have a regulator record of GMP manufacturing.

Ordered by score. Scores follow the published rules and are not affected by paid placement. Updated 2026-11-13.

Micafungin API DMF holders (5)

Source: FDA Drug Master File list. Holding a DMF is a regulatory filing, not an FDA approval.

Biocon Ltd
Bengaluru, India
High
GMP

Bengaluru biopharma company that makes generic APIs and complex formulations, including GLP-1 peptides. Holds US DMFs for liraglutide, semaglutide and tirzepatide.

Model
Manufacturer
Manufacturer?
Yes
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
GMP

Hyderabad-based MSN Group entity holding US DMFs for 11 peptide APIs, including semaglutide and tirzepatide. MSN runs 27 plants in India, the USA and Indonesia.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionWholesaleInternational Shipping
TAPI NL B.V. (TAPI)
Amsterdam, Netherlands
High
GMP

Dutch holding entity of TAPI, Teva's API and CDMO business, with peptide development and GMP production across a global plant network. Holds US DMFs for 9 peptide APIs.

Model
CDMO
Manufacturer?
Yes
GMP CertifiedIn-House ProductionWholesaleInternational Shipping

Main operating subsidiary of Hong Kong-listed Hansoh Pharma, founded 1995; holds US DMFs for degarelix and icatibant.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale
Hetero Drugs Ltd
Hyderabad, India
Medium

Privately held Hyderabad generics and API group with 36+ plants; US DMFs for semaglutide and vasopressin.

Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesale

Other peptide APIs

Related

Frequently asked questions

Who manufactures Micafungin API?

Companies holding active US DMFs for Micafungin include Biocon Ltd, MSN Life Sciences Private Ltd (MSN Group), TAPI NL B.V. (TAPI), Jiangsu Hansoh Pharmaceutical Group Co., Ltd and Hetero Drugs Ltd. Other manufacturers may supply it without a US DMF.

Where are Micafungin API manufacturers based?

Among listed DMF holders: India (3), Netherlands (1), China (1).

Does a DMF mean the API is FDA approved?

No. FDA reviews a DMF when a drug application references it and does not approve DMFs on their own.