Aurisco Pharmaceutical has good reasons to celebrate. On its 25th anniversary, the high-tech pharmaceutical company dedicated to innovation has received its first Marketing Authorization Approval in China for AUXITON(R), the oral finished dosage form of Dydrogesterone, from China's Health Authority, the NMPA. Aurisco is the only company holding both an active USDMF and a valid CEP -- the Certificate of compliance with the European Pharmacopoeia, issued by the EDQM for the drug substance.

As explained by Vivian Shan, MD, Aurisco Pharmaceutical's Medical Manager for this program, "AUXITON(R) provides doctors a safe and convenient, orally bioavailable dydrogesterone - a highly selective progestogen receptor agonist. With an equivalence dose 10--20 times lower than progesterone due to its better bioavailability and the progestogenic nature of the metabolites, dydrogesterone has multiple advantages over natural progesterone, ensuring efficacy and safety to establish the adequate levels for luteal support during natural pregnancy and in-vitro fertilization (IVF). Integrating the production of API, formulation and finished dosage, Aurisco ensures product quality, productivity, and cost advantages throughout the entire industrial chain, to guarantee adequate productivity and stable supply to meet new clinical programs. Following international cGMP and EHS standards, product quality is in line with China, Europe, and United States standards.

The company have been working with the best generic pharmaceutical companies in the world, supplying them safe, sustainable, affordable and high-quality products. Leveraging on technologically advanced and differentiated capabilities, also work with innovators, offering contract research, development and manufacturing services (CRDMO).