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Results For "483"

187 News Found

Briefs: Cipla and IOL Chemicals and Pharmaceuticals
News | January 21, 2025

Briefs: Cipla and IOL Chemicals and Pharmaceuticals

Mesalazine is used to treat inflammatory bowel disease


Granules India update on USFDA inspection at Gagillapur facility
News | December 05, 2024

Granules India update on USFDA inspection at Gagillapur facility

Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA


Briefs: Jagsonpal Pharmaceuticals, Dr. Reddy’s Laboratories and Akums Drugs and Pharmaceuticals
News | November 20, 2024

Briefs: Jagsonpal Pharmaceuticals, Dr. Reddy’s Laboratories and Akums Drugs and Pharmaceuticals

Jagsonpal Pharmaceuticals has received full consideration of Rs. 41 crore towards the sale of the facility and will now be proceeding with registration formalities


Merck receives positive EU CHMP opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM
Drug Approval | November 16, 2024

Merck receives positive EU CHMP opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM

Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial


Wanbury Q2 FY25 revenue at Rs. 161.2 crore, up 11.6%
News | November 16, 2024

Wanbury Q2 FY25 revenue at Rs. 161.2 crore, up 11.6%

EBITDA for the quarter is Rs. 21.6 crore as against Rs. 18.1 crore in Q2 FY24


Granules India’s Unit V facility secures USFDA EIR with NAI status
Drug Approval | November 10, 2024

Granules India’s Unit V facility secures USFDA EIR with NAI status

The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit


Alembic Pharmaceuticals Q2 FY25 PAT up 12% to Rs. 153 Cr
News | November 07, 2024

Alembic Pharmaceuticals Q2 FY25 PAT up 12% to Rs. 153 Cr

US Generics grew 5% to Rs. 467 Crores for the quarter


USFDA inspection of Shilpa Medicare Unit VI at Bengaluru
Drug Approval | November 02, 2024

USFDA inspection of Shilpa Medicare Unit VI at Bengaluru

The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature


Briefs: NATCO Pharma, Mylan Pharmaceuticals, Novo Nordisk and Alembic Pharmaceuticals
News | October 09, 2024

Briefs: NATCO Pharma, Mylan Pharmaceuticals, Novo Nordisk and Alembic Pharmaceuticals

Mylan and Novo Nordisk reach settlement of US patent litigation related to Ozempic


USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
Drug Approval | September 30, 2024

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

The inspection concluded with the issuance of a form 483 with five observations