Caplin Steriles, a subsidiary of Caplin Point Laboratories has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ketorolac Tromethamine Injection
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On Thursday, the U.S. Food and Drug Administration announced the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease
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The FDA panel voted 11-1 with one abstention, in favor of Lynparza, in combination with other medications – abiraterone and prednisone or prednisolone – as a first-line treatment for a type of treatment-resistant prostate cancer in adult patients
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On Friday, Biocon Biologics stated in an exchange filing that its integrated, multi-product, monoclonal antibodies (mAbs) Drug Substance manufacturing facility (B3) at Biocon Park, Bengaluru, has received a Certificate of GMP Compliance for an additional product, biosimilar Bevacizumab
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On Thursday, Mumbai-based IPCA Laboratories informed in an exchange filing that the USFDA conducted the inspection of the company's formulations manufacturing unit situated at Piparia (Silvassa) from 18th April 2023 to 26th April 2023
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Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Icosapent Ethyl Capsules, 0.5 g and 1 g equivalent to the US Reference Listed Drug, Vascepa Capsules
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It has been directed by the United States Food and Drugs Administration to take corrective actions at its Mohali facility before releasing any more final product batches into the US
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The Dholka manufacturing facility passed the USFDA audit with nil 483 observations, which signifies compliance and conformance to applicable Current Good Manufacturing Practice (cGMP) regulations enforced by the USFDA
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