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Results For "Form-483"

117 News Found

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


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


Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
Drug Approval | September 29, 2024

Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations


Briefs: Biocon, Aarti Drugs and Glenmark Pharmaceuticals
Drug Approval | September 22, 2024

Briefs: Biocon, Aarti Drugs and Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations


Briefs: Dr. Reddy's Laboratories and Torrent Pharmaceuticals
Drug Approval | September 20, 2024

Briefs: Dr. Reddy's Laboratories and Torrent Pharmaceuticals

USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation


Gland Pharma posts 16% revenue growth in Q1 FY25
News | August 07, 2024

Gland Pharma posts 16% revenue growth in Q1 FY25

The drugmaker's net profit slipped 26 per cent on-year to Rs 143.8 crore