Granules India Shares in Focus; Receives USFDA Approval for ADHD Treatment

Granules India gets USFDA approval for Lisdexamfetamine Dimesylate Chewable Tablets, a crucial drug for ADHD and Binge Eating Disorder treatment. The approval aims to tackle ongoing drug shortages in the U.S.

Details of the Regulatory Approval

The approval pertains to the company’s Abbreviated New Drug Application (ANDA) for the drug, which is commonly used for treating Attention Deficit Hyperactivity Disorder (ADHD) and Moderate to Severe Binge Eating Disorder (BED).

The chewable tablets are available in multiple strengths including 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, and 60 mg, the company said in a press release on the stock exchanges today.

Addressing U.S. Drug Shortages

Granules India’s subsidiary, Granules Pharmaceuticals, Inc. (GPI), received approval for the product, which has been confirmed as bioequivalent (AB Rating) to Takeda Pharmaceuticals USA Inc.’s Vyvanse Chewable Tablets.

The drug’s approval comes at a crucial time, as it is listed on the FDA’s Drug Shortages List, underscoring its importance in patient care.

This approval, received in the first review cycle, highlights Granules’ commitment to providing high-quality, affordable medications and addressing critical shortages in the U.S. healthcare market.

Granules India now holds 68 ANDA approvals, including 30 from GPI, strengthening its position in the global pharmaceutical market.

Share Price Performance

On December 17, 2024, Granules India’s share price traded 0.45% higher, at ₹586.70 at noon on the NSE. The stock opened at ₹582.20, lower than the previous close of ₹584.10. Granules India’s current PE ratio stands at 37.92, while its PB ratio is 4.43, indicating the company’s valuation relative to its earnings and book value.

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