Friday, Mar 29 2024 | Time 15:18 Hrs(IST)
image
Business Economy


Granules gets USFDA approval for complex, Attention Deficit Hyperactivity Disorder Drug

Granules gets USFDA approval for complex, Attention Deficit Hyperactivity Disorder  Drug

Mumbai, Sep 11 (UNI) Pharma major, Granules on Friday said that its US subsidiary has received marketing approval from the U.S. Health Regulator (FDA) for Dexmethylphenidate HCl extended-release capsules

Dexmethylphenidate HCl extended-release capsules is used for the treatment of Attention-Deficit Hyperactivity disorder ((ADHD). Granules' capsule product is bioequivalent to the reference listed drug (RLD), Focalin XR.



Priyanka Chigurupati, Executive Director of Granules Pharmaceuticals Inc. said "This approval from Granules Pharmaceuticals Inc, received within 13 months of filing reiterates our strength in the development of complex generics. The approval of Dexmethylphenidate XR, a complex, extended-release C-II product, is a good addition to our portfolio. We will be launching the product in the US market soon."

The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia.

Granules now have a total of 30 ANDA approvals from the US FDA (28 Final approvals and 2 tentative approvals).

According to IQVIA Health,Dexmethylphenidate HCl ER Capsules had U.S. sales of approximately USD556 million for the most recent twelve months ending in July 2020.

Focalin XR is a trademark of Novartis AG.

UNI JS SB 1207

More News
India's core sector output rises to three-month high of 6 7 pc in February

India's core sector output rises to three-month high of 6 7 pc in February

28 Mar 2024 | 7:51 PM

New Delhi, Mar 28 (UNI) Driven primarily by coal, cement and crude oil production, India's core sector comprising of eight key infrastructure components grew 6.7% year-on-year in February 2024, as per data released by Ministry of Commerce and Industry on Thursday.

see more..

Honda Motorcycle & Scooter India achieves historic 6 cr domestic sales milestone

28 Mar 2024 | 7:19 PM

Mumbai, Mar 28 (UNI) Honda Motorcycle & Scooter India (HMSI) announced on Thursday that it has accomplished a historic achievement of 6 crore domestic sales in India. Honda ventured into the Indian market with its first two-wheeler, the Activa, in 2001.

see more..

28 Mar 2024 | 5:28 PM

UNI NK AKS.

see more..
Luminous enters solar panel mfg; 250 MW facility launched with initial investment of Rs 120 cr

Luminous enters solar panel mfg; 250 MW facility launched with initial investment of Rs 120 cr

28 Mar 2024 | 5:16 PM

Rudrapur, Mar 28 (UNI) From power Back-up solutions to Batteries and Solar applications, Luminous Power Technologies on Thursday announced the launch of its state-of-the-art solar panel manufacturing facility here.

see more..

Kottayam-Kochi Rubber Market rates

28 Mar 2024 | 5:04 PM

Kottayam, Mar 28 (UNI) Following were the Rubber Market rates announced by the Rubber Board here on Thursday per quintal.

see more..
image