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Results For "FDA-inspection"

111 News Found

Briefs: Alembic Pharmaceuticals and Shelter Pharma
News | March 24, 2025

Briefs: Alembic Pharmaceuticals and Shelter Pharma

Alembic Pharmaceuticals successfully completes USFDA inspection for API-III facility


Briefs: Zydus, Alkem Laboratories, Alkem Medtech and Relonchem
Drug Approval | March 19, 2025

Briefs: Zydus, Alkem Laboratories, Alkem Medtech and Relonchem

Alkem Medtech to acquire 100% stake of Bombay Ortho


Briefs: Alembic Pharma and IOL Chemicals and Pharmaceuticals
Drug Approval | March 07, 2025

Briefs: Alembic Pharma and IOL Chemicals and Pharmaceuticals

USFDA inspection at Alembic Pharma's Bioequivalence facility


Briefs: Emcure and Relonchem
Drug Approval | February 27, 2025

Briefs: Emcure and Relonchem

USFDA inspection at Emcure Pharmaceuticals API facility


Gland Pharma reports Q3 FY25 revenue at Rs. 1,384 Cr
News | February 04, 2025

Gland Pharma reports Q3 FY25 revenue at Rs. 1,384 Cr

Our Q3 FY25 revenue was at Rs. 1,384.1 crore with an EBITDA of Rs. 360 crore resulting in a 26% EBITDA margin


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


Caplin Point receives EIR from FDA with Zero 483 observations
Drug Approval | January 07, 2025

Caplin Point receives EIR from FDA with Zero 483 observations

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.


ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility
Drug Approval | December 21, 2024

ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility

The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe


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


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