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
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
EBITDA grew by 31% YoY with EBITDA margin of 11%, a YoY improvement of over 170bps vs. Q1FY24
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
This existing GMP compliant facility, located at Bharuch (Unit-1) with ongoing expansion part of the company's strategic capex initiative
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
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
This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently
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