Anhui Poly Pharm. Co., Ltd. (hereinafter referred to as “Anhui Poly”), a holding subsidiary of Hainan Poly Pharm. Co., Ltd. (hereinafter referred to as “Poly Pharm.”), has recently received certificate of suitability to monograph of European Pharmacopeia (hereinafter referred to as “CEP”) of cyclophosphamide API issued by European Directorate for the Quality of Medicines & HealthCare (hereinafter referred to as “EDQM”).
The CEP certificate indicates that the API meets the quality requirements of the European Pharmacopoeia and shows the recognition and affirmation of the quality of the API by the European regulatory market, bringing positive impact on expanding of international market by Anhui Poly.
In addition, the production workshop has passed the FDA on-site inspection in 2023, the API manufacturing is in compliance with FDA's cGMP requirements, and the products will be supplied to global customers stably and consistently in the future.
Product Name: Cyclophosphamide
Name in EP: CYCLOPHOSPHAMIDE MONOHYDRATE
Dosage Form: API
Packing Specification: 25kg/drum
Holder: Anhui Poly Pharm. Co. Ltd.
CEP Certificate No.: CEP 2022-356 - Rev 00
US DMF No.: 037154 (Status: A; has been bundled with preparation and passed technical review)
CN Registration No.: Y20220000793 (Status: A; the product has passed the domestic GMP compliance inspection).
Cyclophosphamide is an alkylating, cytotoxic drugs, which can interfere with the function of DNA and RNA, cross-bind with DNA, and inhibit DNA synthesis. The dosage forms of drug product include tablet, capsule and injection, etc. This drug has a wide anti-tumor spectrum and wide clinical application, and has certain curative effect on malignant lymphoma, acute or chronic lymphocyte, leukemia and other tumors.
Anhui Poly’ supply capacity could reach 10 tons, being able to provide API supply for production of different dosage forms of cyclophosphamide (lyophilized powder for injection, tablet, capsule, injection). Meanwhile, the production line is a cytotoxic production line, which has the production capacity of various types of cytotoxic products.
According to the IMS database, the global market sales of cyclophosphamide in 2023 is as high as 275 million USD, and the global consumption of the API in 2023 is 10 tons. From the perspective of the global API demand market, Brazil, China, US, India, Russia, Japan, France, Germany, Italy, Spain and UK are the main markets, accounting for 80% in total. Anhui Poly’s cyclophosphamide API has obtained the qualification to enter the main markets.
1）The product quality is comparable with that of RLD, and the microbial limit is strictly controlled (TAMC<10cfu/g, bacterial endotoxin≤0.025EU/mg);
2）Dedicated production in cytotoxic workshop, with the annual supply capacity of 10 ton, and high degree of automation for production line; on the basis of ensuring stable supply, product quality is further guaranteed.
This API has been filed/registered in China, US and EU markets;
① US DMF number is 037154 (status: A; has been bundled with preparation and passed technical review);
The cyclophosphamide API has passed the technical review in the US DMF, and received the First Adequate Letter (FAL) issued by the US Food and Drug Administration (FDA).
The workshop has passed the FDA on-site inspection in 2023, and the API manufacturing is in compliance with FDA's cGMP requirements.
② The CN registration No. is Y20220000793 (Status: A), and the product has passed the domestic registration verification and GMP compliance inspection.
③ CEP certificate no.: CEP 2022-356 - Rev 00; conforming to quality requirements of EP
Meanwhile, registration in other markets is also in progress.
Anhui Poly would exert its product advantages, international registration ability (our registration team has completed registration of the product in many countries, and has a wealth of international registration experience), as well as internationalization manufacturing, quality control system and mature international market development ability, to provide all-round and in-depth cooperation with domestic and international drug product customers who are interested in market development of cyclophosphamide, creating a better future.
Anhui Poly Pharm., located in Anqing National High-tech Industrial Development Zone, is a professional supplier of active ingredients, dedicated to providing chemically synthesized and biosynthesized high-quality specialty ingredients to the global pharmaceutical, healthcare, and skin care sectors.
At present, Anhui Poly has 3 API production workshops, 10 production lines and 357 multifunctional equipment which meet the GMP standards of EU, US and China.
Relying on strong R&D capabilities and technological transformation capabilities, Anhui Poly has successfully completed the R&D and production of contrast agents (including Gadoterate Meglumine, Gadoteridol, Gadobutrol, Iomeprol, Iopromide, Ioversol, Iopamidol, Iodixanol), Semaglutide, Ectoin & Salidroside (by synthetic biology), anti-tumor substance (Cyclophosphamide), other APIs (Magnesium Hydroxide, Apremilast, Crisaborole, Voriconazole, Memantine Hydrochloride), and other pharmaceutical excipients (DOTA, SNAC, Betadex Sulfobutyl Ether Sodium, Calteridol Calcium, Calcobutrol).
Cyclophosphamide is one of the APIs in the high-end anti-tumor field layout plan of Poly, and has broad market prospects. The approval of this product marks another solid step for Poly Pharm. in this field and has a positive impact on Poly’s market expansion.
