Drug Approval | February 27, 2025
Briefs: Emcure and Relonchem
USFDA inspection at Emcure Pharmaceuticals API facility
USFDA inspection at Emcure Pharmaceuticals API facility
Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’
Observations are largely around improvement of procedures and practices
The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated
The Alathur facility specializes in the production of Cephalosporin antibiotics
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Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
The company said it voluntarily paused production at the Gagillapur plant in September 2024 for risk assessment on account of the USFDA observations
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Mesalazine is used to treat inflammatory bowel disease
FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe
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