Recently, Anhui Poly Pharm Co., Ltd., a wholly-owned subsidiary of Hainan Poly Pharm. Co., Ltd., received the Establishment Inspection Report (EIR) issued by the U.S. Food and Drug Administration (FDA). This marks the second time that Anhui Poly Pharmaceutical Co., Ltd. has successfully passed the U.S. FDA inspection.
Hainan Poly Pharm. Co., Ltd. has consolidated its advanced manufacturing positioning centered on the "differentiation + vertical integration of APIs and finished dosage forms + internationalization" strategy, forming a comprehensive system that integrates key intermediates, active pharmaceutical ingredients (APIs), and finished formulations. Through in-house production of APIs and intermediates, the Company has effectively achieved cost controllability and supply chain stability, and has fully streamlined the pharmaceutical value chain through resource integration.
Its wholly-owned subsidiary, Anhui Poly Pharmaceutical Co., Ltd., established in 2019, is committed to becoming a specialty supplier that provides high-quality chemical synthesis and bio-manufactured raw materials and services to the global pharmaceutical, healthcare, and skincare sectors.
Through technological innovation, the Company has successfully completed the R&D and industrial conversion of a series of products, including gadoteric acid meglumine salt, gadoteridol, gadobutrol, ioversol, iohexol, iopamidol, iodixanol, and ethiodized oil, and is now fully capable of commercial supply. The DMFs (Drug Master Files) for Anhui Poly's gadoteric acid meglumine salt API (DMF 037072), gadoteridol API (DMF 037960), and gadobutrol API (DMF 039149) have all been approved by the U.S. FDA.
In addition, the Company has also completed the R&D, production, and commercial conversion of a series of other products, including magnesium hydroxide, sodium nitroprusside, dobutamine hydrochloride, tecovirimat, brofovirdine, voriconazole, apremilast, cyclophosphamide, crisaborole, and memantine hydrochloride.
For products involving the Tenth Batch of National Centralized Drug Procurement varieties—specifically the APIs for dobutamine hydrochloride, apremilast (apremilast), and gadoteric acid meglumine salt—Anhui Poly will take the lead in implementing preferential supply policies. We sincerely invite and warmly welcome industry peers to inquire, and we look forward to exploring new insights and cooperation opportunities together.
Through its synthetic biology technology, the Company has successfully developed the API Semaglutide. The product is obtained by fermenting genetically engineered strains to produce the peptide backbone, followed by two-step chemical reactions, achieving a product purity of over 98%. To date, the Company has completed process development and scale-up batch production of the high-purity API.
Meanwhile, for SNAC, the key excipient used in the oral semaglutide formulation, the Company has also completed laboratory-scale, scale-up, and validation batch production, and has filed with the CDE (Center for Drug Evaluation, NMPA) and the U.S. FDA DMF.
Leveraging its synthetic biology platform, the Company is also focusing on the biosynthetic development of key raw materials for dietary supplements, functional foods, and cosmetics. By employing gene-editing technologies such as CRISPR/Cas, the Company has rationally reconstructed product synthesis pathways in a variety of industrial production chassis cells, including Escherichia coli, yeast, and Corynebacterium glutamicum. Combined with the optimization of metabolic pathway network regulation, the Company has successfully achieved microbial fermentation production of multiple raw materials, including ectoine, salidroside, and NMN (nicotinamide mononucleotide), thereby completing industrial transformation and establishing a competitive cost advantage.
The Company has successfully developed a range of innovative drugs, including the anti-tumor nanomedicine PLAT001, the dual-modality contrast agent PL002 for injection, and the 505(b)(2) boron neutron capture therapy (BNCT) anti-tumor innovative drug—BPA (borofalan, ¹⁰B-enriched) for injection. The APIs for all these innovative drugs have been developed and manufactured by Anhui Poly. In addition, the Company has also successfully developed the API BSH (disodium mercaptoundecahydrododecaborate, ¹⁰B-enriched).
Anhui Poly Pharmaceutical Co., Ltd. has accumulated extensive experience in the development, industrial conversion, and manufacturing of innovative drug APIs, and has established a comprehensive and well-structured technical system and production capacity. The Company is well-positioned to undertake CMO (Contract Manufacturing Organization) and CDMO (Contract Development and Manufacturing Organization) partnerships for innovative drugs, providing high-quality and efficient services to industry partners.
The Company is equipped with modern analytical instruments and production equipment. Currently, it operates three production workshops with a total of 357 multi-functional equipment units, covering advanced technologies such as ultrafiltration, nanofiltration, freeze-drying, centrifugation, three-in-one systems, DAC columns, spray drying, and automatic sub-packaging.
The Company has established three API production workshops that comply with cGMP standards of the EU, U.S., and China, including production lines for iodinated contrast agents, gadolinium-based contrast agents, small-batch specialty products, anti-tumor products, general products, and bio-fermentation products. In addition, the Company operates one finished dosage form workshop for oncology products, equipped with 15 production lines. A stringent cGMP quality system for high-end APIs in line with EU and U.S. standards, as well as a high-standard EHS (Environment, Health, and Safety) system, has been implemented to ensure product quality and deliver sustainable, high-quality services.
Leveraging its product advantages, international registration capabilities (having successfully registered products in multiple countries with extensive international regulatory experience), international manufacturing expertise, quality control systems, and well-established global market development capabilities, Anhui Poly is committed to providing comprehensive and in-depth cooperation with both domestic and international formulation customers who are interested in developing these products, to jointly create a shared future.
We welcome your inquiries and look forward to mutually beneficial cooperation!
Business Contact: apisale@hnpoly.com
