Drug Approval | February 27, 2025
USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit
The observations issued are neither repeated observations nor related to data integrity
The observations issued are neither repeated observations nor related to data integrity
Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’
The acquisition aligns with Granules' vision to enter the rapidly expanding peptide-based anti-diabetic and anti-obesity market
The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated
the inspection conducted from January 27 to January 31, 2025
Observations are largely around improvement of procedures and practices
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Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
Our Q3 FY25 revenue was at Rs. 1,384.1 crore with an EBITDA of Rs. 360 crore resulting in a 26% EBITDA margin
OneSource operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies
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Mesalazine is used to treat inflammatory bowel disease
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