Granules India announced on Wednesday, December 13, that it has received approval for the Pantoprazole Sodium delayed-release tablets from the United States Food and Drug Administration (USFDA). The drug is used for treating damage from Gastroesophageal Reflux diseases.
The US drug regulator has approved the company’s Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium Delayed-Release Tablets in the dosages of 20mg and 40mg, Granules India said in a filing to the stock exchanges.
The approved ANDA is bioequivalent as well as therapeutically equivalent to the reference-listed drug product (RLD) of Wyeth Pharmaceuticals LLC’s Protonix Delayed-Release Tablets having the same dosages of 20 mg and 40 mg.
The drug, Pantoprazole Sodium Delayed-Release Tablets are indicated in the short-term treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD), Maintenance of Healing of Erosive Esophagitis and Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome, according to the pharma company.
As per IQVIA or IMS Health MAT data for October 2023, the present annual market for the aforementioned Pantoprazole Tablets in the US is estimated to be $233 million.
The Hyderabad-based pharmaceutical company now has a cumulative total of 64 ANDA approvals from the USFDA, of which 62 are final approvals and two are tentative ones.
For the quarter ended September, Granules India reported a 6.64% growth in net profit at ₹116.16 crore compared to ₹108.93 crore in the same period last year, while its net sales increased 4.76% to ₹1,009.4 crore in the quarter, from ₹963.6 crore in the year-ago period.
Granules India shares traded 0.84% lower at ₹385.6 per piece on BSE at 12:05 PM.
(Edited by : Asmita Pant)
Check out our in-depth Market Coverage, Business News & get real-time Stock Market Updates on CNBC-TV18. Also, Watch our channels CNBC-TV18, CNBC Awaaz and CNBC Bajar Live on-the-go!
Telangana Lok Sabha elections 2024: Asaduddin Owaisi to Bandi Sanjay Kumar, a look at key candidates
May 11, 2024 3:32 PM
Lok Sabha elections 2024: Hyderabad to Kadapa, key seats in fourth phase
May 11, 2024 2:54 PM
Telangana Lok Sabha elections 2024: List of BRS candidates
May 11, 2024 1:55 PM