Marksans Pharma Inc. receives USFDA approval for Loperamide Hydrochloride Tablets
Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhoea
Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhoea
The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer
The observations are procedural in nature and will be responded to within the stipulated time
Dexlansoprazole delayed-release capsules are a proton pump inhibitor
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
The Cranbury facility represents a strategic advancement of the company's operations in the Unted States
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