The inspection has concluded successfully on 1st September 2023 without any critical/major observation
Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR
Mankind Pharma's initiative aims to ensure universal access to medicines of international calibre
Juergen Eckhardt joined Bayer in 2016 to help start Leaps by Bayer
The company is committed to address the observations and will submit its response to US FDA within the stipulated time
Zinc Sulfate Injection is indicated in adult and paediatric patients as a source of zinc for parenteral nutrition
The drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat
The company has entered into a three-year Deferred Prosecution Agreement
Weinand is the former CEO and Chairman of the Board at Bayer Pharma AG, leading Bayer’s fully integrated $20 billion healthcare business
The deal represents a total transaction value of up to $36 million with an initial upfront consideration of $14 million
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