Granules India shares surged mid-session on Tuesday, jumping 0.8% to hit ₹589.50 at the time of writing, following its announced of a key FDA approval secured by its US unit.
The Hyderabad-based pharmaceutical giant saw its stock rise after its wholly-owned US subsidiary, Granules Pharmaceuticals, Inc. (GPI), received US Food and Drug Administration approval for its Lisdexamfetamine Dimesylate Chewable Tablets — a generic version of Takeda Pharmaceuticals’ Vyvanse.
This critical approval positions Granules India to enter the ADHD and Binge Eating Disorder (BED) treatment markets in the US.
The drug, available in multiple strengths ranging from 10 mg to 60 mg, caters to both adult and pediatric patients aged six and older.
The FDA has Lisdexamfetamine listed on its Drug Shortages List — a fact highlighted by the company’s Chairman & Managing Director Dr. Krishna Prasad Chigurupati as reinforcing Granules India’s dedication to ” alleviating critical drug shortages in the U.S. healthcare market.”
Granules now boasts of 68 abbreviated new drug approvals (ANDAs), including 30 ANDAs filed through the U.S. subsidiary.
Market Reaction: Granules India’s share price opened at ₹582.20 and climbed to a session high of ₹590.
The pharmaceutical major, which has a 52-week high of ₹721.00 and a low of ₹365.45, has delivered significant returns this year at nearly 43%, with a current market cap of ₹14,280 Crore.
The stock is currently trading at a price-to-earnings ratio of 29.3 and at over 4.2 times the book value.
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