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On March 2, Puli Pharmaceuticals announced that the company obtained the FDA's provisional approval for bivalerudin for injection in December 2020, and in January 2021, it will issue a marketing license and patent holder for the original formulation of the product.
It is understood that Bivarudine is a synthetic anticoagulant drug.
At the same time, Puli Pharmaceuticals has notified the FDA of the above-mentioned progress and has submitted an application for final approval of the generic bivalrudine for injection.