The U.S. Food and Drug Administration has issued an establishment inspection report (EIR) with a voluntary action indicated (VAI) classification to an injectable facility of Zydus Lifesciences in Vadodara. The company received the EIR for a GMP follow-up inspection the U.S. FDA conducted at the facility in Jarod, Vadodara, from August 25 to September 5, […]
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Zydus Lifesciences subsidiary Zydus Worldwide DMCC has received final approval from the U.S. Food and Drug Administration to market Selexipag Tablets in different strengths. Indicated in adults for treatment of pulmonary arterial hypertension (PAH), the reference listed drug of the approved product is Uptravi tablets. Since it was one of the first applicants to submit […]
Continue ReadingEligible for 180 days shared exclusivity for Brivaracetam tablets. Eligible for 180 days shared exclusivity for Brivaracetam tablets. Drugmaker Zydus Lifesciences has received the United States Food and Drug Administration (USFDA) approval to market Brivaracetam tablets. An antiepileptic drug, the approved product is a generic of multinational pharma firm UCB’s Briviact. “U.S. subsidiary Zydus Pharmaceuticals […]
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