These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products
Sun Pharma's Halol plant gets OAI classification from US FDA inspection
The inspection conducted from December 16, 2024 to December 20, 2024 by the Brazil Health Regulatory Agency (ANVISA)
The Subsidiary has received one inspectional observation in Form 483
The inspection has concluded with four observations
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’
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Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
The company is committed to address this observation comprehensively within stipulated time
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