GRANULES INDIA

Granules India received FDA approval for Lisdexamfetamine Dimesylate chewable tablets, a generic version of Takeda's Vyvanse for ADHD and BED. The drug is bioequivalent, available in multiple strengths, and aims to address drug shortages in the U.S.

Granules India receives USFDA approval for Bupropion Hydrochloride ER Tablets, expanding their ANDA approvals to 67. The tablets treat major depressive disorder and prevent seasonal affective disorder.

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Granules India's Gagillapur facility completes US FDA inspection with six observations, focusing on cGMP and PAI processes. The company is committed to addressing these and will submit a response within the stipulated timeframe.

Granules India Ltd's Gagillapur facility in Hyderabad completed a USFDA inspection with six observations, focusing on cGMP and PAI processes. The facility manufactures FDs and PFIs, supporting global operations. The company's net profit rose to ₹135 crore in Q1 FY25, with a 19.7% YoY revenue growth and 90% YoY EBITDA rise.

FDA inspection at Granules India's Hyderabad plant resulted in six observations. The Gagillapur facility, producing finished dosages and intermediates, was inspected from Aug. 26 to Sept. 6. Granules India aims to address these promptly.