Parecoxib Sodium is the first parenteral selective COX-2 inhibitor available for clinical use in pain management
The approval allows it to market its products in the country
Sun Pharma gets 8 observations from USFDA for Halol facility
This approval marks a significant milestone in OneSource’s ongoing commitment to quality and regulatory compliance
Sharma brings a wealth of expertise in optimizing manufacturing processes for fermentation-based APIs and sterile injectables
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
Everolimus TFOS is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex for the treatment of subependymal giant cell astrocytoma
The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market
Esketamine hydrochloride is a vital drug to be used for treating mental illness and is likely to significantly impact the LATAM market
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