Granules India Ltd. on Tuesday announced that it received approval for its Metoprolol Succinate Extended-Release Tablets from the United States Food and Drug Administration (USFDA).
The US health regulator has provided approval to the pharmaceutical company’s Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended-Release Tablets in the dosages 25 mg, 50 mg, 100 mg, and 200 mg.
The approved ANDA is bioequivalent of the reference-listed drug product (RLD) of Toprol Acquisition LLC’s Toprol-XL Tablets having the same dosages.
Metoprolol Succinate ER Tablets are used in the treatment of hypertension in order to lower blood pressure.
As per IQVIA or IMS Health MAT data for March 2023, the present annual market for the Metoprolol Succinate ER Tablets in the US is around $321 million.
Granules India now has a cumulative total of 57 ANDA approvals from the USFDA, of which 55 are final approvals and 2 are tentative ones.
Last month, Granules India received USFDA approval for Venlafaxine Hydrochloride extended-release capsules, which are used in the treatment of major depression and anxiety-related conditions.
For the March quarter, Granules India reported a better-than-expected growth of consolidated revenue at Rs 1,196 crore, up 16 percent from Rs 1,030 crore in the year-ago period. Its operating profit margins too increased by 40 bps to 19.1 percent versus 18.7 percent in the year-ago quarter.
Shares of Granules India ended 2.11 percent higher at Rs 285.35 on Tuesday.
(Edited by : Rukmani Krishna)
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