Anhui Poly Pharm. Co., Ltd. (hereinafter referred to as "Anhui Poly"), a subsidiary of Hainan Poly Pharm. Co., Ltd. (hereinafter referred to as "Poly Pharm."), has recently received the certificate of suitability for the European Pharmacopoeia (CEP) for the pharmaceutical excipient Betadex Sulfobutyl Ether Sodium issued by European Director for the Quality of Medicine&HealthCare (hereinafter referred to as "EDQM").
The acquisition of this CEP certificate indicates that the excipient meets the quality requirements of the European Pharmacopoeia, demonstrating the recognition and affirmation of the quality of the excipient by the European regulatory market. Bringing positive impact to Anhui Poly's further expansion into the international market.
Product Name: Betadex Sulfobutyl Ether Sodium
Dosage: Pharmaceutical Excipient
EU Name：Sulfobutylbetadex Sodium
USP Name：Betadex Sulfobutyl Ether Sodium
Betadex Sulfobutyl Ether Sodium is an excipient that can be used as a pharmaceutical excipient in injectable, oral, nasal, and ophthalmic medications. It has special affinity and inclusion compatibility for nitrogen-containing drugs.
The excipient is mainly used in the injection of ziprasidone mesylate, voriconazole, aripiprazole, remdesivir, posaconazole, delafloxacin, carbamazepine and other products.
This product is an anionic, highly water-soluble β - cyclodextrin derivative developed by Cydex Company in the 1990s. It is not a single compound component, instead, it is composed of various high polymer isomers with different degrees of substitution and positions/regions. It can effectively form noncovalent complexes with drug molecules, thereby improving the stability, water solubility, safety of the drug, reducing nephrotoxicity, alleviating drug hemolysis, controlling drug release rate, and masking adverse odors. Compared with β - cyclodextrin, it has better water solubility, less hemolysis, and lower nephrotoxicity, making it a new type of medicinal excipient with broad application prospects.
1) In compliance with USP and EP specification;
2) Relative low limit of impurity B and low limit of endotoxin, which is conducive to the expansion and use of different formulations;
3) We can provide finished products with different pH values and degrees of substitution according to customer needs;
4) Dedicated production line that can provide stable supply; Annual production capacity of over 100 tons.
This product has been filed/registered as an active pharmaceutical ingredient in markets such as China, the United States, and Europe,
① CN registration number F20220000553, (status: I);
② US DMF number 037814, (status: A);
③ European certification number: CEP 2022-504-Rev 00;
The registration work in other markets is also ongoing.
The acquisition of this CEP certificate indicates that the excipient meets the quality requirements of the European Pharmacopoeia, demonstrating the recognition and affirmation of the quality of the excipient by the European regulatory market. According to the EDQM CEP certificate database, Anhui Poly is the second company to obtain the CEP certificate for this product, which has a positive impact on Anhui Poly's further expansion into the international market.
Anhui Poly Pharm., founded in 2018 and 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 and services 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 for commercialization of contrast agents (including Gadoterate Meglumine, Gadoteridol, Gadobutrol, Iomeprol, Iopromide, Ioversol, Iopamidol, Iodixanol), Ectoin & Salidroside (by synthetic biology), anti-tumor substance (Cyclophosphamide), other APIs (Magnesium Hydroxide, Apremilast, Crisaborole, Voriconazole, Memantine Hydrochloride), and other pharmaceutical excipients (DOTA, Betadex Sulfobutyl Ether Sodium, Calteridol Calcium, Calcobutrol).
Anhui Poly has obtained the CEP certificate for the excipient Betadex Sulfobutyl Ether Sodium, which will fully leverage the advantages of global registration and manufacturing internationalization, utilize international high-end production capacity, and assist in the commercial production of products.
