Drug Approval | March 22, 2025
SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
The change is reflective of the company’s evolving vision aimed at further strengthening its global presence and a commitment to providing innovative solutions in the API and CDMO space
The biosimilar Ustekinumab has been developed and manufactured by the company
Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
Q1FY25 Revenue from Operations grew by 15% to Rs. 177 crore
The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA
Enhanced collaboration under the Memorandum of Cooperation (MoC) between India and Japan in medical product regulations
Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care
Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility
Before joining Gland, Loomba was associated with Shalina Labs, Harman Finochem, Aurobindo Pharma, Sun Pharmaceuticals and Ranabaxy Laboratories.
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