Taixing-based Space Peptides Pharmaceutical (Taizhou) has obtained the U.S. Food and Drug Administration's (FDA) Drug Master File (DMF) filing for its semaglutide active pharmaceutical ingredient (API), marking the company's first overseas DMF clearance and granting it full access to mainstream global pharmaceutical markets.
Backed by a total investment exceeding 1 billion yuan ($147.2 million), the firm specializes in end-to-end peptide drug services spanning early discovery, process development, GMP (good manufacturing practice) manufacturing and global commercial registration.
Space Peptides Pharmaceutical (Taizhou) in Taixing, Jiangsu province. [Photo/WeChat account: txfabu]
The milestone reflects the company's strengths in API research, development, production and quality control, opening new overseas revenue channels while elevating Taixing's biomedical industry profile in high-end international pharmaceutical segments.
Biomedicine is a key priority in Taixing's "333" modern industrial system — referring to the development of three clusters of distinctive, advantageous industries, three strategic emerging sub-sectors, and three future industries. The system has been making steady progress in the API and finished dosage segments.
Local authorities will continue optimizing the industrial ecosystem to support more enterprises in new drug R&D, green manufacturing and international regulatory filings, fostering a clustered, high-growth biomedical industrial chain.