About Us
Founded on July 6, 2021, through the restructuring of Amphastar Pharmaceuticals, Inc. (USA) China R&D Center, Nanjing Hanxin Pharmaceuticals Co., Ltd. has a registered capital of CNY 183 million. Leveraging advanced technology platforms and strong R&D capabilities, Hanxin has emerged as a global pharmaceutical leader specializing in the research, production, and commercialization of peptides, proteins, and polysaccharides (APIs and finished dosage forms).
13,000㎡ R&D Center: Equipped with state-of-the-art laboratories for prokaryotic/eukaryotic expression, protein engineering, peptide synthesis, enzymatic catalysis, nanoformulations, microparticle technology, and ultra-trace analysis. Supports end-to-end development from discovery to pilot-scale production for global regulatory filings (US, EU, China).
200,000㎡ GMP Formulation Facility: FDA- and GMP-compliant manufacturing site producing injectables, gels, ointments, suppositories, tablets, and capsules for global markets.
100,000㎡ API+Formulation Site (ANP): Successfully passed 3 FDA inspections with zero Form 483 observations, adhering to EU/US EHS standards. Features multi-ton peptide production lines for diverse APIs and finished drugs.
35,000㎡ API Base (Minghai): Developing new ton-scale peptide production lines and continuous-flow chemical synthesis, targeting FDA approval for oncology, hormonal, and conventional APIs.
Exports: Products marketed in 30+ countries across North America, the EU, ASEAN, and MENA.
Domestic Network: Collaborations with over 6,000 hospitals and 190,000 pharmacies nationwide.
Hanxin Advantages: Your End-to-End Biopharma Solution
Proven Regulatory Success - Approved peptide/protein/polysaccharide products in both China & U.S. markets
Smart Formulation Tech - Custom-developed APIs to meet exact regulatory requirements
One-Stop Solution - API + finished dosage co-development for local registration
