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On September 22, Puli Pharmaceuticals issued an announcement stating that it had recently received a marketing authorization for bivalrudine for injection issued by the British Medicines and Health Products Administration (MHRA), which indicated that the company has the qualification to sell the product in the UK
Table 1: Basic situation of drugs
Source: Company announcement
Bivarudine is a synthetic anticoagulant drug.
The announcement mentioned that after the successful research and development of Puli Pharmaceutical's bivalrudine for injection, it has submitted generic drug registration applications in Europe, China, the United States, and the United Kingdom and other countries and regions, which belong to the common-line production varieties
Figure 1: The situation of bid-winning enterprises in the national centralized procurement of Bivarudin for injection
Source: Minet.
In China, Puli Pharmaceutical's bivalrudine for injection was approved for production in 2020 and deemed to have been evaluated.
Source: Company announcement, Minet database