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Viwit Pharmaceuticals' Vildagliptin API Receives Official Approval by China NMPA
- Categories:In 2023
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- Time of issue:2023-12-07 08:31
(Summary description)On November 30, 2023, Viwit Pharmaceuticals received the "Notice of Approval of Application for Listing of Chemical APIs" issued by National Medical Products Administration (NMPA) for its independently developed active pharmaceutical ingredient (API), Vildagliptin. The registration number is Y20210000619, and the notice number is 2023YS00803.
Viwit Pharmaceuticals' Vildagliptin API Receives Official Approval by China NMPA
(Summary description)On November 30, 2023, Viwit Pharmaceuticals received the "Notice of Approval of Application for Listing of Chemical APIs" issued by National Medical Products Administration (NMPA) for its independently developed active pharmaceutical ingredient (API), Vildagliptin. The registration number is Y20210000619, and the notice number is 2023YS00803.
- Categories:In 2023
- Author:
- Origin:
- Time of issue:2023-12-07 08:31
- Views:
On November 30, 2023, Viwit Pharmaceuticals received the "Notice of Approval of Application for Listing of Chemical APIs" issued by National Medical Products Administration (NMPA) for its independently developed active pharmaceutical ingredient (API), Vildagliptin. The registration number is Y20210000619, and the notice number is 2023YS00803.
The receipt of the approval notice signifies that Viwit Pharmaceutical’s Vildagliptin complies with the relevant regulations for domestic pharmaceutical drug registration. This marks the official approval for the listing of the API in the Chinese market.
In addition to obtaining approval for manufacturing and listing in China, Viwit Pharmaceutical’s Vildagliptin has already been submitted for approval in several other countries, including Russia and Ukraine. This fully demonstrates the strong implementation of our company's strategy for integrating drug substance - and - drug product, as well as the internationalization of raw material drugs and formulations development and manufacturing.
Vildagliptin, the global second DPP-4 inhibitor authorized for commercialization. Is distinguished for its therapeutic efficacy in reducing blood glucose concentrations among patients with the Type II Diabetes, without inducing hypoglycemic events or influencing body weight. Vildagliptin was originally developed by Novartis and approved by the European Medicines Agency in 2007. Subsequently, it gained approval from the National Medical Products Administration (NMPA) to enter the domestic market in China in August 2011.
In 2017, Vildagliptin, along with four other gliptin class DPP-4 inhibitors, achieved inclusions in the China National Medical Insurance Catalog. Leveraging the distinctive advantages of DPP-4 inhibitors in the field of oral hypoglycemic pharmaceutical drugs, and coupled with the expiration of the original drug patent as well as the intense market competition, Vildagliptin tablets secured a position in the batch of China National Centralized Procurement Variety Catalog in 2020. This makes Vidagliptin the pioneering incorporation of a DPP-4 inhibitor in the centralized procurement initiative.
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