Archive · 22 Dec 2025
Granules India Gets USFDA Nod for ADHD Drug
Granules India, a pharmaceutical company, got a tentative approval from the US FDA for a new drug that helps people with ADHD.
This drug will be made in Virginia, USA.
The company is happy because this approval shows they are doing well in making special medicines.
They also got some notes from the FDA about their factory in Hyderabad, but these notes are not very serious.
The company's stock price went up a little bit.
This news is important because it shows Granules India is trying to make more kinds of medicines and follow the rules in the USA.
Granules Pharmaceuticals Inc. received tentative USFDA approval for an ADHD drug.
The drug will be manufactured at the Chantilly, Virginia facility.
The US market size for this drug is approximately $172 million.
Granules India's Hyderabad unit received a USFDA form 483 with five observations.
The company's stock closed up by 0.3% at ₹583.3 per share.
- Who
- Granules India Limited and its subsidiary Granules Pharmaceuticals Inc.
- What
- Received tentative USFDA approval for an ADHD drug and a form 483 with five observations at its Hyderabad unit.
- When
- The inspection was conducted from 15th to 19th December 2025.
- Where
- The drug will be manufactured in Chantilly, Virginia, and the observations were at the Hyderabad unit.
- Why
- To expand its portfolio of complex and differentiated generics and strengthen its presence in the central nervous system therapeutic area.
- Company
- Granules India Limited
- Subsidiary
- Granules Pharmaceuticals Inc.
- Approval
- Tentative USFDA approval for ADHD drug
- Market Size
- $172 million (US market)
- Manufacturing Location
- Chantilly, Virginia
- Stock Performance
- Up 0.3% at ₹583.3 per share (previous trading session)
- Regulatory Observation
- USFDA form 483 with five observations at Hyderabad unit
