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Results For "observations"

251 News Found

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


USFDA inspection update on Jubilant HollisterStier’s Montreal facility
Drug Approval | September 30, 2024

USFDA inspection update on Jubilant HollisterStier’s Montreal facility

HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures


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


Ami Organics reports Q1FY25 PAT lower 34% at Rs. 14.7 Cr
News | August 12, 2024

Ami Organics reports Q1FY25 PAT lower 34% at Rs. 14.7 Cr

Q1FY25 Revenue from Operations grew by 15% to Rs. 177 crore


Caplin Point announces completion of unannounced USFDA inspection
Drug Approval | August 11, 2024

Caplin Point announces completion of unannounced USFDA inspection

The inspection was concluded with zero observations


Atul Bioscience received EIR from USFDA for Ambernath facility
Drug Approval | August 09, 2024

Atul Bioscience received EIR from USFDA for Ambernath facility

The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations


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