Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements

Apitoria Pharma receives 3 observations from USFDA for Unit-V

The company will respond to the US FDA within the stipulated timelines

Bengaluru healthtech firm Biomoneta secures USFDA nod for air purifier

Captured microbes are then neutralized on engineered microbicidal surfaces

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

Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla

The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia

Lupin receives 7 observations from USFDA for Goa manufacturing facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe

NATCO Pharma receives 7 observations from USFDA for API unit at Manali

Zydus receives final approval from USFDA for Leuprolide Acetate injection

Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer

Aurobindo Pharma gets 9 observations from USFDA for Unit 2 of Eugia Pharma Specialities

The observations are procedural in nature and will be responded to within the stipulated time