Thymalfasin API manufacturers

Thymalfasin is thymosin alpha 1, an immunomodulating peptide (Zadaxin).

3 listed companies hold an active US Type II Drug Master File for Thymalfasin API, based in China (3). 1 has a regulator record of GMP manufacturing, and 1 carries an open FDA warning letter.

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

Thymalfasin API DMF holders (3)

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

High

Suzhou peptide API and formulation maker founded in 2000, flagship of Tianma Pharma Group, offering CRO/CMO/CDMO services. Holds US DMFs for 8 peptide APIs.

Model
CDMO
Manufacturer?
Yes
In-House ProductionWholesaleInternational Shipping
Medium

Suzhou API and intermediates producer offering customized manufacturing. Holds US DMFs for semaglutide, thymalfasin and tirzepatide.

Model
CDMO
Manufacturer?
Yes
In-House ProductionWholesaleInternational Shipping
Low
GMP

Harbin peptide API maker founded in 2011. Holds US DMFs for 11 peptide APIs. FDA issued it a CGMP warning letter in May 2026 that remains open.

Notice: open regulatory issue
Model
Manufacturer
Manufacturer?
Yes
In-House ProductionWholesaleInternational Shipping

Other peptide APIs

Related

Frequently asked questions

Who manufactures Thymalfasin API?

Companies holding active US DMFs for Thymalfasin include Suzhou Tianma Pharma Group Tianji Bio-Pharmaceutical Co., Ltd., Suzhou Ryway Biotech Co., Ltd. and Harbin Jixianglong Biotech Co., Ltd.. Other manufacturers may supply it without a US DMF.

Where are Thymalfasin API manufacturers based?

Among listed DMF holders: China (3).

Do any Thymalfasin API holders have FDA warning letters?

Harbin Jixianglong Biotech Co., Ltd. has an open FDA warning letter, shown on the listing and in the FDA enforcement tracker.

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.