Hainan Poly Pharmaceutical Co., Ltd. (hereinafter referred to as "Poly Pharmaceutical"), through its holding subsidiary Anhui Poly Pharmaceutical Co., Ltd. (hereinafter referred to as "Anhui Poly"), has recently received the Certificate of Suitability to the European Pharmacopoeia (hereinafter referred to as the "CEP Certificate") for the active pharmaceutical ingredient Voriconazole, issued by the European Directorate for the Quality of Medicines & HealthCare (hereinafter referred to as "EDQM").
The receipt of this CEP Certificate for Voriconazole attests to the conformity of the active pharmaceutical ingredient with the quality requirements set forth in the European Pharmacopoeia, and signifies the acknowledgment and validation of its quality by the European regulatory market. This milestone will positively influence Anhui Poly's ongoing efforts to broaden its presence in the global marketplace.
Voriconazole is a triazole antifungal agent that exerts its therapeutic effect by inhibiting cytochrome P450-mediated 14α-sterol demethylation in fungi, thereby blocking ergosterol biosynthesis. It exhibits fungicidal activity against a broad spectrum of pathogens, including Aspergillus species, filamentous fungi, Candida species, and various yeasts. The product is characterized by its high potency, broad-spectrum activity, extensive tissue distribution, high bioavailability, and favorable penetration into deep tissues. It is recognized as the first-line agent of choice for the prophylaxis and treatment of potentially life-threatening fungal infections in patients.
Voriconazole for injection was developed by Pfizer Inc., receiving marketing authorization from the European Medicines Agency (EMA) in March 2002, approval from the U.S. Food and Drug Administration (FDA) in May 2002, and subsequent approval by the National Medical Products Administration (NMPA) of China in October 2004, under the brand name VFEND®.
According to IMS data, China and the United States rank first and fifth, respectively, in global output of voriconazole injections, accounting for 57% and 3% of the global market share. In the Chinese market, Poly Pharmaceutical's voriconazole for injection was successfully selected in the eighth round of the National Volume-Based Procurement (VBP) program, and has maintained steady growth in market share, underpinned by its superior product quality and reliable supply capacity. Concurrently, the Company has remained steadfast in executing its globalization strategy in overseas markets, continuously expanding and deepening its international presence. This sustained effort has resulted in a growing number of overseas marketing authorizations, translating strategic initiatives into tangible commercial outcomes. To date, the Company has secured market access eligibility representing 65% of the global market share.
1)Superior product quality, consistent with the reference listed drug (RLD);
2)Product complies with the pharmacopoeial standards of multiple jurisdictions, including ChP, EP, and USP;
3)Dedicated production line in place, ensuring stable and reliable supply;
4)Annual production capacity exceeding the tonne-level.
Anhui Poly's Voriconazole API has been filed/registered in key markets including China, the United States, and Europe, with high-quality API meeting the registration, production, and sales requirements across various regulatory tiers.
① U.S. DMF No.: 038466 (Status: A – Active);
② China NMPA Registration No.: Y20230000941 (Status: I – Inactive);
③ CEP Certificate No.: CEP 2023-327-Rev 00, conforming to the quality requirements of the European Pharmacopoeia;
Registration activities in other markets are also progressing steadily.
The excipient for Voriconazole, Sulfobutylbetadex Sodium, has been filed/registered in markets including China, the United States, and Europe, with registration dossiers submitted as follows:
① China NMPA Registration No.: F20220000553 (Joint review with the finished product: Status A – Active);
② U.S. DMF No.: 037814 (Status: A – Active);
③ European Certificate No.: CEP 2022-504-Rev 00;
Registration activities in other markets are also progressing steadily.
These regulatory achievements will lay a solid foundation for Poly Pharmaceutical's Voriconazole for Injection to ensure stable and sustained supply, and to serve global customers in the future.
Anhui Poly will leverage its inherent product advantages, capitalize on its international regulatory expertise (having successfully registered products in multiple countries with extensive global registration experience), and draw upon its internationally compliant manufacturing and quality control systems, as well as its proven capabilities in global market development. We are eager to provide comprehensive and in-depth cooperation with both domestic and international formulation customers who aspire to commercialize this product, and to work together in shaping a shared future.
Anhui Poly Pharmaceutical Co., Ltd. is located in the Anqing National High-Tech Industrial Development Zone. The company is a professional supplier of active pharmaceutical ingredients (APIs), providing high-quality specialty raw materials produced through chemical synthesis and biosynthesis to the global pharmaceutical, healthcare, and skincare sectors.
Anhui Poly currently operates 10 API production lines that comply with GMP standards of the European Union, the United States, and China, equipped with 357 multifunctional devices.
Leveraging its strong R&D capabilities and exceptional technology transfer expertise, Anhui Poly has successfully completed the development and production of a comprehensive range of products, including:
Contrast media（Gadoteric Acid Meglumine Salt, Gadoteridol, Gadobutrol, Iomeprol, Iopromide, Ioversol, Iopamidol, Iodixanol, etc）.;Synthetic biology products: （Semaglutide, Ursodeoxycholic Acid, Ectoine, Salidroside, etc.）;
Oncology APIs（ BPA, Cyclophosphamide, etc）.;Other API（: Dobutamine Hydrochloride, Sodium Nitroprusside, Magnesium Hydroxide, Apremilast, Crisaborole, Voriconazole, Glycopyrronium Bromide, Memantine Hydrochloride, Tecovirimat, Acyclovir Sodium, Ganciclovir Sodium, Bumetanide, Fluconazole, Selenium Disulfide, Allopurinol, etc,）;
Other pharmaceutical excipients( DOTA, SNAC, Sulfobutyl-β-Cyclodextrin Sodium, Cartolyd Calcium, Cobuprocal Calcium Sodium, etc.)
Welcome for enquiry, cooperation！
