Recently, Hainan Poly Pharm Co., Ltd. (hereinafter referred to as "Poly Pharm") and its controlled subsidiary Anhui Poly Pharm Co., Ltd. (hereinafter referred to as "Anhui Poly") received the Notice of Approval for the Marketing Application of Crisaborole Active Pharmaceutical Ingredient (API) issued by the National Medical Products Administration (NMPA). With the approval of this domestic marketing application (Status: A; Approved for use in marketed formulations), it marks that Anhui Poly's Crisaborole API has obtained market access in China. Previously, Anhui Poly's Crisaborole API had already been registered with the US FDA DMF and converted to "A" status, with DMF No. 039148.
Crisaborole is a novel small-molecule, non-hormonal, non-steroidal anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor, developed by Pfizer Inc. in the United States. It was approved by the U.S. FDA in December 2016 as the first prescription drug for the treatment of atopic dermatitis (AD) to be approved in a decade. Subsequently, Crisaborole received marketing authorization in multiple countries and regions, and was approved by the NMPA in China in July 2020.
According to statistics published by IMS, the total global consumption of Crisaborole API reached 1,118 kilograms in 2024, demonstrating a sustained growth trend.
In the global Crisaborole API market, China and the United States hold a dominant position, accounting for 54% and 26% of the market share respectively, making them the two largest consuming countries worldwide. To date, Anhui Poly's Crisaborole API has obtained market access and sales eligibility covering approximately 80% of global demand.
For inquiries and cooperation opportunities, please feel free to contact us.
Business Contact: apisale@hnpoly.com
1)Product quality is consistent with the reference listed drug (RLD);
2)The manufacturing process is managed in accordance with cGMP standards, ensuring stable and reliable product quality;
3)Comprehensive N‑nitrosamine impurity studies and elemental impurity studies have been conducted in compliance with the latest regulatory guidelines and requirements;
4)Product quality meets the pharmacopoeial standards of multiple authorities, including the Chinese Pharmacopoeia and the U.S. Pharmacopoeia (USP).
Dedicated production lines with a high degree of automation are in place, providing greater assurance of product quality.
The annual production capacity is at the metric ton level, ensuring a stable and reliable supply.
The API has been filed/registered in both the Chinese and U.S. markets:
US DMF No.: 039148 (Status: A)
CN Registration No.: Y20240000303 (Status: A)
Anhui Poly will leverage its product advantages, international registration capabilities, as well as its globally oriented manufacturing and quality control systems, and its proven expertise in international market development. We are committed to providing comprehensive and in-depth cooperation with both domestic and international formulation customers who are interested in developing this product, working together to create a shared future.
For inquiries and cooperation opportunities, please feel free to contact us.
Business Contact: apisale@hnpoly.com
Anhui Poly Pharm Co., Ltd., established in 2018 and located in the Anqing National High-tech Industrial Development Zone, is a professional supplier of active pharmaceutical ingredients (APIs), providing high-quality specialty raw materials through chemical synthesis and biosynthesis to the global pharmaceutical, healthcare, and skincare industries.
Anhui Poly Pharm boasts a strong and efficient R&D and production team, equipped with modern production facilities, and has established a rigorous cGMP quality system aligned with high-end European and U.S. API standards, as well as a high-standard EHS (Environment, Health, and Safety) system. In addition to providing high-quality APIs and intermediates, the company also offers CDMO (Contract Development and Manufacturing Organization) services and process technology improvements. The company currently operates 3 API production workshops that comply with EU, U.S., and China GMP standards, 10 production lines, and 357 multi-functional equipment units.
Leveraging its strong R&D capabilities and technology transfer expertise, Anhui Poly Pharm has successfully commercialized the R&D and production of a comprehensive portfolio of products, including:
Contrast media: Gadoteric Acid Meglumine Salt, Gadoteridol, Gadobutrol, Iomeprol, Iopromide, Ioversol, Iopamidol, Iodixanol, etc.;Synthetic biology products: Semaglutide, Ectoine, Salidroside;
Oncology API: Cyclophosphamide;Other APIs: Magnesium Hydroxide, Apremilast, Crisaborole, Voriconazole, Memantine Hydrochloride;Other pharmaceutical excipients: DOTA, SNAC, Sulfobutylbetadex Sodium, Calteridol Calcium, Combretastatin Calcium.
For inquiries and cooperation opportunities, please feel free to contact us.
Business Contact: apisale@hnpoly.com
