Granules India Receives FDA Approval for Metoprolol Succinate ER Tablets
In a recent announcement, Granules India Limited revealed that the US Food & Drug Administration (FDA) has granted approval to its Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended-Release Tablets USP. The approved tablets come in four variants with strengths of 25 mg, 50 mg, 100 mg, and 200 mg. This news was disclosed by the company through an official exchange filing.
The newly approved tablets have been determined to be bioequivalent to the reference listed drug product (RLD) named Toprol-XL Tablets. Toprol-XL, developed by Toprol Acquisition LLC, is available in the market with strengths mirroring those of Granules’ tablets.
With this latest approval, Granules India has amassed a total of 57 ANDA approvals from the US FDA. Out of these, 55 are final approvals while 2 are tentative approvals. According to IQVIA/IMS Health’s data from March 2023 (MAT Mar 2023), the current annual US market size for Metoprolol Succinate ER Tablets is estimated to be around $321 million.
Metoprolol Succinate ER Tablets are primarily prescribed for managing hypertension and aiding in the reduction of high blood pressure.
About Granules India:
Granules India Limited is an Indian pharmaceutical manufacturing company situated in Hyderabad, India. The company specializes in the production of various off-patent drugs, such as Paracetamol, Ibuprofen, Metformin, and Guaifenesin, catering to both regulated and global markets. Granules manufactures these drugs on a large scale to meet the demands of its customers.
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