Passed FDA Inspection: a FDA cGMP field inspection was conducted on Anhui Poly Pharm. Co., Ltd (hereinafter referred to as "Anhui Poly"), a wholly owned subsidiary of Hainan Poly Pharm. Co., Ltd (stock code: 300630), from August 21, 2023 to August 25, 2023. Recently, we have received the EIR issued by the U.S. FDA, which is a pre-approval inspection and involves the products including gadoterate meglumine DMF 37072 and cyclophosphamide DMF 037154, indicating that the Company's drug manufacturing activities are in compliance with the cGMP requirements of the U.S. FDA, which provides a solid safeguard for the Company's continuous expansion in the U.S. market, and positively affects the expansion of the regulated markets around the globe. This will provide a solid guarantee for the Company's continuous expansion in the U.S. market and bring a positive impact on the expansion of global regulated market.
Product Information:
Gadoterate Meglumine is a novel gadolinium analog with an ionic macrocyclic structure used as an intravenous contrast agent for magnetic resonance imaging (MRI). IMS data shows that gadoterate meglumine global preparation sales grew from $430 million in 2018 to $480 million in 2022, and API consumption also grew from 58 tons in 2018 to 102 tons in 2022. The product is on the growth stage, with a large potential for growth and a promising future.
Cyclophosphamide, as a commonly used antitumor drug, is widely used in various tumors, such as commonly used in malignant lymphoma, acute or chronic lymphocytic leukemia, and multiple myeloma. It is effective in breast cancer, testicular tumor, ovarian cancer, lung cancer, squamous head and neck cancer, nasopharyngeal cancer, neuroblastoma, rhabdomyosarcoma and osteosarcoma. It is now also commonly used in rheumatic and kidney diseases. IMS data show that cyclophosphamide 2022 global preparation sales of $276 million, API consumption of 9.8 tons. It is a first-line antitumor product with high market recognition.
Conditions of workshop and production line: 5 API workshops and 1 oncology preparation workshop were designed for Anhui Poly, among which 3 API workshops have been put into production, including iodine contrast agent production line, gadolinium contrast agent production line, small varieties production line, anti-tumor production line, general production line, and bio-fermentation production line. The two varieties of Gadoterate meglumine and Cyclophosphamide which passed the FDA field inspection are located in the Gadolinium contrast agent production line and Anti-tumor production line respectively. Gadolinium contrast agent workshop, designed and constructed in accordance with the standards requirements of FDA, EU and the new version of GMP, the production line contains gadoterate meglumine, gadobutrol, gadoteridol and other gadolinium series products. It has pharmaceutical equipment of first-class brands at home and abroad, such as Dedietrich, Pfaudler, Morimatsu, PALL, Tofflon, etc. It has a full set of process equipment for synthesizing, separating, drying (lyophilizing), ultrafiltration, pulverizing, mixing, etc. The comprehensive annual production capacity of gadolinium series products can reach more than 100 tons/year. Cyclophosphamide API workshop, designed and constructed in accordance with the standards of FDA, EU and the new version of GMP, the workshop is a cytotoxicity workshop, which adopts a completely enclosed production process. It has pharmaceutical equipment of first-class brands at home and abroad, such as Dedietrich, Pfaudler, Morimatsu, Sateri, etc. and a full set of process equipment for synthesizing, separating, drying, and packaging, with an annual production capacity of up to 30 tons/year or more.
Up to this U.S. FDA approval, Anhui Poly Pharm. has already passed the U.S. international certification for 2 production lines, being ready for international markets. Anhui Poly Pharm. has formed a complete internationalized manufacturing and quality control system and has an excellent team with efficient R&D and international registration. Anhui Poly adheres to the characteristic API and global internationalization strategy and has a mature international market development system. Anhui Poly is willing to provide a full range of customized services for CDMO/CMO partners who are interested in going to the international market and is also willing to cooperate deeply with international enterprises to create the future together.
Anhui Poly Pharm. is a professional supplier of active ingredients, dedicated to providing chemically synthesized and biosynthesized high-quality specialty ingredients and services to the global pharmaceutical, healthcare, and skin care sectors. The company has a strong and efficient R&D and production team, equipped with modern production facilities, established a strict European and American high-end API cGMP quality system and a high standard EHS system, to provide customers with high-quality APIs and intermediates at the same time, but also to provide CDMO, process technology improvement and so on. At present, the company has 3 API production workshops, 10 production lines and 357 multifunctional equipment which meet the GMP standard of EU, US and China. Relying on the strong R&D capability and technology conversion ability, we have completed the commercialization of contrast media (gadoterate meglumine, gadoteridol, gadobutrol, iomeprol, iopromide, ioversol, iopamidol, iodixanol, etc.), synthetic biology (semaglutide, ectoin, salidroside, ursodeoxycholic acid, etc.), anti-tumor (cyclophosphamide, etc.), other APIs (magnesium hydroxide, apremilast, crisaborole, voriconazole, memantine hydrochloride, etc.), other pharmaceutical excipients (SNAC, DOTA, Sulfobutylether-β-Cyclodextrin, calteridol calcium, calcobutrol, etc.), and other series of products, and their commercial development, production, and global registration.
