The Indian pharmaceutical industry is a global leader, ranking third in volume and 14th in value, with a market size of over $50 billion. Known as the “pharmacy of the world,” it supplies 20% of global generic medicines and is a key player in vaccines, exporting to over 200 countries. The industry is driven by strong R&D, cost-effective manufacturing, and a skilled workforce.
Companies like Sun Pharma, Dr. Reddy’s, Cipla, and Granules India lead the sector. With increasing healthcare spending, rising chronic diseases, and export demand, India’s pharma industry has immense growth potential, especially in biotechnology, biosimilars, and innovative drug development.
Share Price
The shares of Granules India Limited are currently trading at Rs. 559.5 up by 4.62% from its previous close of Rs. 534.8 as of January 30, 2025. The stock also touched an intraday high of Rs. 565.15.
What is USFDA?
The U.S. Food and Drug Administration (USFDA) is a government agency responsible for regulating food, drugs, medical devices, and other health-related products in the United States. Its approval ensures that a drug is safe, effective, and meets high standards of quality.
USFDA approval is crucial for market entry, as it provides patients with confidence in a medication’s safety and efficacy while also allowing pharmaceutical companies to legally sell their products in the U.S. market.
Recent Updates
Granules India Receives FDA Approval for Lisdexamfetamine Dimesylate Capsules On January 30, 2025, Granules India Limited announced the U.S. Food & Drug Administration (FDA) approval for its generic Lisdexamfetamine Dimesylate Capsules. Available in various strengths (10 mg to 70 mg), this drug is bioequivalent to Vyvanse Capsules and is indicated for treating Attention Deficit Hyperactivity Disorder (ADHD) in both adults and children six years and older, as well as for Moderate to Severe Binge Eating Disorder (BED) in adults.
Binge Eating as a Type of ADHD
Binge Eating Disorder (BED) shares symptoms with ADHD, as both conditions involve difficulties in impulse control and emotional regulation. In BED, individuals often struggle to stop eating, even when not hungry, much like how those with ADHD struggle to focus or manage impulses. The approval of this drug strengthens Granules’ ADHD and BED treatment options, providing new choices for patients managing both conditions.
Management Commentary
Dr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India Limited said, “With this latest approval, we are reinforcing our presence in the ADHD treatment space and strengthening our portfolio of complex generics.”
About the Company
Granules India Limited, founded in 1991, is a fast-growing pharmaceutical company headquartered in Hyderabad. According to the company, it is a vertically integrated organization with best-in-class facilities, committed to operational excellence, quality, and customer service.
They are among the few pharmaceutical companies globally involved in the entire value chain, which includes the manufacturing of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs).
Granules India stated that its products are distributed to over 300 customers across regulated and semi-regulated markets, with a global presence in more than 80 countries. The company mentioned it operates 10 manufacturing facilities, 8 of which are located in India and 2 in the USA.
Written By: Dipangshu Kundu
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