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 Notice of Approval for Listing Application of Memantine Hydrochloride API issued by National Medical Products Administration (hereinafter referred to as “NMPA”).
The approval of this listing application indicates that the Anhui Poly’s Hydrochloride Memantine API product has achieved commercial production, successful registration, and approval, and can be associated with domestic downstream preparations. The product is stable and continuously supplied to global customers.
（1）Product Name: Memantine Hydrochloride
（2）Dosage Form: API
（3）Registration No.: Y20230000102
（4） Packing Specification: 15kg/drum
（5） Holder: Anhui Poly Pharm. Co. Ltd.
Memantine Hydrochloride is a novel N-methyl-D-aspartate (NMDA) receptor antagonist with a unique mechanism of action that protects neuronal function and promotes cognitive recovery. It is suitable for moderate to severe Alzheimer's dementia and can improve cognitive impairment in patients.
Developed jointly by Merz, Lundbeck, and Forest Laboratories, it was first approved for market by the European Medicines Agency (EMA) on May 15, 2002, and then by the US Food and Drug Administration (FDA) on October 16, 2003. It was later approved for market by the Japanese Medicines and Medical Devices Agency (PMDA) on January 21, 2011. It is marketed and sold by Lundbeck in Europe under the brand name Ebixa, and by Forest Laboratories in the United States under the brand name Namenda.
At present, the international Alzheimer's disease guidelines have recommended NMDA receptor antagonists as first-line treatment drugs for Alzheimer's disease. It is the first drug approved by the FDA for the treatment of moderate to severe dementia. As the only NMDA receptor antagonist currently available for the treatment of moderate to severe AD, memantine hydrochloride plays a crucial role in combating AD.
According to the IMS database, the global market sales of memantine hydrochloride in 2023 is as high as 690 million USD, and the global consumption of the API in 2023 is 33 tons. From the perspective of the global API demand market in 2023, Spain, Japan, the United States, Brazil, Germany, Russia, Mexico, Argentina, South Korea, Italy, China are the main markets. Anhui Poly’s memantine hydrochloride API has been registered as DMF API in the US market with a status of A, and has also been approved domestically with a status of A. It has obtained access to two major markets and the registration in the European market is also progressing in an orderly manner.
According to the MeNet database, the sales revenue of memantine hydrochloride in China in 2023 is 230 million RMB, while the domestic consumption of API in 2023 is 1.2 tons according to the Yaozh database.
1）With product purity over 99.9%, the product quality is excellent with high stability.
2）All indicators in the finished product are better than the quality requirements of ChP and USP.
3）The particle size can be customized according to customer needs.
4）There is a dedicated production line that can provide stable supply.
This API has been filed/registered in China, and US markets.
① US DMF number is 037154 (status: A);
② CN DMF number is Y20230000102 (status: A), Registration work in other markets is also ongoing.
The registration in the European market is also progressing in an orderly manner.
Anhui Poly Pharm., founded in 2018, was 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. It is equipped with a strong and efficient R&D and production team, modern production facilities, and have established a strict cGMP quality system and high standard EHS system for high-end APIs in Europe and America. It can provide customers with high-quality APIs and intermediates, as well as CDMO, process technology improvement and other services.
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).
Memantine hydrochloride is one of the APIs in the high-end AD 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.
