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Viwit’s Levetiracetam Tablets Approved by FDA 2024-04-09 11:28:41
On April 5, 2024, Viwit Pharmaceuticals' Levetiracetam Tablets received an Approval Letter (#078869) from the U.S. Food and Drug Administration (FDA), marking Viwit's first approved oral solid dosage in the United States.
Viwit Pharmaceuticals' Mirabegron API Receives Official Approval by China NMPA 2024-01-26 11:09:29
On January 23, 2024, Viwit Pharmaceuticals received the "Notice of Approval of Application for Listing of Chemical APIs" issued by China National Medical Products Administration (NMPA) for its own proprietary active pharmaceutical ingredient (API) Mirabegron, developed independently. The issued registration number is Y20220000096, and the corresponding notice number is 2024YS00039.
Viwit Pharmaceuticals' Vildagliptin Tablets Receive Official Approval by China NMPA 2023-12-22 13:19:44
Viwit Pharmaceuticals is pleased to announce the acquisition of the Drug Registration Certificate (Certificate No: 2023S01974) from the National Medical Products Administration (NMPA) for a proprietary finished dosage form, Vildagliptin tablet. This signifies the official approval of this product in the Chinese market.
Viwit Pharmaceuticals' Lidocaine Injection Receives Official Approval by China NMPA 2023-12-19 11:25:05
On December 18, 2023, Viwit Pharmaceuticals received the "Drug Supplementary Application Approval Notice" (Notice No: 2023B06224) issued by the China National Medical Products Administration for a proprietary finished dosage form, Lidocaine Hydrochloride for Injection (5ml: 0.1g).
Viwit Pharmaceuticals' Vildagliptin API Receives Official Approval by China NMPA 2023-12-07 08:31:28
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' Aprepitant API Receives Official Approval by China NMPA 2023-10-31 15:33:57
On October 26, 2023, Viwit Pharmaceuticals received the "Notice of Approval of Application for Listing of Chemical APIs" issued by China National Medical Products Administration (NMPA) for the independently developed active pharmaceutical ingredient (API) Aprepitant. The registration number is Y20210000473, and the notice number is 2023YS00727.

      Development History

In December 2019

威智医药

API production base has passed the US FDA GMP certification for the first time

In October 2018

威智医药

The API production base has passed the GMP certification of health Canada for the first time

In December 2015

威智医药

For the first time, the API production base has been certified by the Mexican ministry of health Cofepris

In August 2015

威智医药

The production base of bacteria-free preparation has obtained Chinese GMP certificate

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