Established in 2018, Anhui Poly Pharm. Co., Ltd., a wholly-owned subsidiary of Hainan Poly Pharm., is an important part of Poly Pharm.'s expansion and layout to APIs. Anhui Poly is large in scale, covering an area of 186.5 mu, with a total investment of about 1 billion.
Anhui Poly strictly follows the standards and concepts of advanced environmental protection, health and safety at home and abroad in terms of design, installation and auxiliary facilities construction so as to reach the advanced level.
Anhui Poly has built a R & D center, with the construction area of 2774㎡, including multiple lab-scale test laboratory, kilogram-scale scale-up laboratory, technical gas-phase analysis room, technical liquid-phase analysis room, and technical physical-chemical analysis room. The center is equipped with modern professional R & D and testing laboratory facilities. The professional equipment and close and effective team provide a strong backing for product development and marketing, and improve Anhui Poly's industrial layout in the API CDMO business, which is conducive to perfecting Anhui Poly's industrial chain, enhancing the company's profitability, and meanwhile, improving the company's competitiveness and sustainable development ability.
Equipped with modern production facilities, Anhui Poly has established strict CGMP system and EHS system, and is dedicated to providing high-quality API and services in chemical synthesis and biosynthesis to the global pharmaceutical, healthcare and skincare fields.
Main products: Semaglutide, Ectoin, Salidroside (by synthetic biology), contrast agents (including Gadoterate Meglumine, Gadoteridol, Gadobutrol, Ioversol, Iopamidol, Iodixanol), anti-tumor substance (Cyclophosphamide), other APIs (Magnesium Hydroxide, Apremilast, Voriconazole, Memantine Hydrochloride), and other pharmaceutical excipients (DOTA, SNAC, Betadex Sulfobutyl Ether Sodium, Calteridol Calcium), etc.
Anhui Poly provides integrated R&D and production services from pre-clinical to commercialization stages for pharmaceutical enterprises and new drug R&D enterprises, including customized R&D services like process R & D, quality research and safety research of preparations and APIs (including pharmaceutical intermediates), as well as production services in different stages and scales (pre-clinical, clinical and commercialization).
Anhui Poly firmly establishes the quality awareness and brand awareness of “ensuring drug quality and building a century-old drug enterprise”, and has established a quality assurance system that is in line with international quality supervision...
In the internationalization process, Anhui Poly attaches great importance to the internationalization of the quality system, and follows the ICH and cGMP standards. At present, its cGMP system has also been gradually geared to Europe and the Unite...
As of Feb. 2024: 22 US DMFs, 7 CEPs, none in India, South Korea and Japan
Raw material R & D institute: main focused R & D direction: (1) featured APIs; (2) medical cosmetics and chemical intermediates; (3) targeted-delivery excipients. Relying on strong talent reserve and technical accumulation, the raw material R & D institute has built a number of characteristic technology platforms, such as safety evaluation test platform, crystal form research test platform, purification technology platform (nanofiltration, ultrafiltration, high pressure and low pressure industrial preparation HPLC system), continuous flow technology platform, fixed bed hydrogenation platform and special drying technology platform (freeze-drying, spray drying). After the accumulation of technology in recent years, Poly Pharm. has more than 20 products ready for production in the Anqing site, including the APIs of contrast agents (gadolinium), contrast agents (iodine), anti-infection products, anti-tumor products and etc. In addition, cosmetics for whitening and moisturizing, excipients for increasing drug dissolution, and ionizable liposomes for mRNA drugs also successively enter the research stage for scale-up production.
Continuous chemistry: Continuous reaction technology is used to protect safety and reduce contamination at the source of the process, and is a globally recognized green path for drug R & D and production. Anhui Poly’s continuous reaction technology has been based on the concept of scale-up production from the beginning, and subject to independent R & D. This concept of continuous production has been applied to a number of innovative drug key intermediates and API projects, especially the nitro reduction reaction of contrast agents (iodine), which will be subject to continuous production in the future. Separation and purification: Anhui Poly has a number of separation and purification instruments including DAC50, DAC100, DAC200, DAC400, DAC1100, electrodialysis, nanofiltration and ultrafiltration instruments, has different types of separation and purification means from R & D to production, and is experienced in method scale-up, method optimization, in-process validation, pilot-scale test and commercial production, with R & D and production capabilities from separation & purification to production regarding APIs and advanced intermediates under cGMP.
