Briefs: Indoco Remedies and Alembic Pharmaceuticals
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
The inspections concluded with no Form 483 observations or significant critical findings
The company will work closely with the USFDA and is committed to address these comprehensively within stipulated time
Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility
The company is committed to address this observation comprehensively within stipulated time
The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
The company will provide comprehensive response to USFDA for the observations
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