Drug Approval | February 23, 2025
Briefs: Syngene International and Cipla
Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’
Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’
The Alathur facility specializes in the production of Cephalosporin antibiotics
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Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
The certification marks a new chapter in Windlas Biotech’s growth trajectory,
The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
Expects to unlock further opportunities in the Moldovan market, contributing anticipated sales of $300,000 in 2025 and approximately $700,000–$800,000 in 2026
Cenexi is committed to working closely with the ANSM to address the observations
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
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