The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility
The inspection was a cGMP Inspection and had ended with NIL observations
The expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs
Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market
The Cephalosporin Injectables plant has a total capacity of 26.4 million vials per year while Ethiopia is having a demand for 16 million vials
VitiPure serves as essential solubilizers, emulsifiers, and bioavailability enhancers in drug formulations
RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US
The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia
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