News | April 25, 2025
Briefs: Ami Organics and Panacea Biotec
Ami Organics’ Ankleshwar Unit II gets GMP compliant by PMDA Japan
Ami Organics’ Ankleshwar Unit II gets GMP compliant by PMDA Japan
This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance
The inspection has concluded with four observations
USFDA inspection at Emcure Pharmaceuticals API facility
Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’
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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
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