China Has 831 CEP Products at 2021
Jan 07, 2022
The European Committee for the Quality of Medicines (EDQM) website closed the registration and publication of the "European Pharmacopoeia Certificate of Indications (CEP)" for 2021 on December 23, 2021. The total number of valid certificates for active pharmaceutical ingredients and excipients (APIs) obtained by pharmaceutical manufacturers worldwide is 5,680, excluding revocations, cancellations and expired item numbers. Among them, 831 are held by Chinese manufacturers, involving 290 enterprises and 390 kinds of compounds and derivatives of active ingredients, which is the second in the world.
The distribution of CEP certificate holders by country over the years shows that India (1950 pieces), China (831 pieces) and Italy (450 pieces) occupy the top three positions. In particular, the certificate holders from China showed a rapid expansion trend in the past four years, with 98 certificates in 2018, 133 in 2019, 171 in 2020 and 281 in 2001.
The CEP certificate of the European Pharmacopoeia is a window for global high-quality APIs and suppliers, indicating that the quality system level of APIs has been recognized by international pharmacovigilance agencies, and its products can be legally used by EU end users as a way of issuing registrations, which will play a positive role in promoting and publicizing the status of products in the international arena. Anhui Keynovo Biotech provides many main products with CEP, such as Hyaluronic Acid, PVP, Chondroitin Sulfate, etc.
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