Drug Approval | February 23, 2025
Briefs: Syngene International and Cipla
Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’
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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Mesalazine is used to treat inflammatory bowel disease
Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA
Jagsonpal Pharmaceuticals has received full consideration of Rs. 41 crore towards the sale of the facility and will now be proceeding with registration formalities
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
US Generics grew 5% to Rs. 467 Crores for the quarter
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
Mylan and Novo Nordisk reach settlement of US patent litigation related to Ozempic
The inspection concluded with the issuance of a form 483 with five observations
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
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