Granules India shares in focus today on tentative USFDA nod for ADHD drug

Shares of Granules India Limited are in focus today after Granules Pharmaceuticals Inc., the wholly-owned American subsidiary of Granules India, received tentative approval from the US Food and Drug Administration for its abbreviated new drug application for Amphetamine Extended-Release Orally Disintegrating Tablets, designed to treat attention deficit hyperactivity disorder (ADHD).

The company stated the product will be manufactured at its facility in Chantilly, Virginia. The estimated US market size is approximately $172 million for the 12 months ending November, according to IQVIA data.

Granules India observed that there is currently only one approved generic and one authorised generic in this market. Krishna Prasad Chigurupati, chairman and managing director, said, “The tentative approval of this ANDA reaffirms Granules’ strategic focus on expanding its portfolio of complex and differentiated generics while strengthening its presence in the central nervous system therapeutic area. ADHD is one of the most commonly diagnosed neurodevelopmental disorders in the United States and impacts hundreds of millions of people worldwide.”

In a separate regulatory disclosure, Granules India announced its Hyderabad unit received a USFDA form 483 with five observations.The inspection conducted from 15th to 19th December 2025 has concluded with five observations related to procedural requirements. None of these observations are associated with data integrity or product safety.

The stock closed the previous trading session up by 0.3% at ₹583.3 per share. Over the last six months, the stock has advanced 17.3%, while it has recorded a decrease of 2.4% for the year so far.

Granules India operates in a sector with multiple generic and speciality pharmaceutical competitors, and the latest tentative approval may strengthen its position in the central nervous system drug market segment. The development signals ongoing efforts to diversify Granules India's generic drug portfolio and its emphasis on US regulatory compliance. The regulatory observations at the Hyderabad facility will likely be addressed in future filings as the company works to uphold quality standards.