Granules India Arm Gets USFDA Nod for ADHD Drug; Shares Trade Flat

Shares of Granules India Ltd are trading flat after touching a day’s high of Rs 589.20 on 22nd December. This comes after the company said its wholly-owned subsidiary, Granules Pharmaceuticals Inc, received tentative approval from the US drug regulator for tablets used to treat attention deficit hyperactivity disorder (ADHD).

The US Food and Drug Administration (USFDA) has granted tentative approval to Granules India’s abbreviated new drug application (ANDA). This approval is for Amphetamine Extended-Release Orally Disintegrating Tablets, which are used to treat ADHD. The approval covers six strengths ranging from 3.1 mg to 18.8 mg. It is the generic version of ADZENYS XR-ODT.

The tablets will be manufactured at Granules’ facility in Chantilly, Virginia, in the United States. According to IQVIA data, the drug has an estimated market size of about $172 million for the 12 months ended November. Currently, the market has only one approved generic and one authorised generic.

Commenting on the development, Chairman and Managing Director Krishna Prasad Chigurupati said the approval highlights Granules’ focus on expanding its complex and differentiated generics portfolio. Additionally, it strengthens its presence in central nervous system therapies. He added that ADHD is among the most commonly diagnosed neurodevelopmental disorders in the US.

Separately, the company said one of its units in Hyderabad received a USFDA Form 483 with five observations.

At 11:14 AM, shares of Granules India were trading 0.73% higher at Rs 587.65 on NSE.

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