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
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
The drugmaker's net profit slipped 26 per cent on-year to Rs 143.8 crore
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
The inspection was concluded with two 483 observations
Glenmark Life Sciences has reported total income of Rs. 594.109 crores during the period ended June 30, 2024
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