Emcure Secures CDSCO Committee nod for manufacturing, marketing of Metoprolol Telmisartan FDC
New Delhi: After reviewing the Bioequivalence (BE) study report of the fixed-dose combination (FDC) of Metoprolol Telmisartan, the Central Drugs Standard Control Organization (CDSCO) committee has given its nod to Emcure Pharmaceuticals Limited for the manufacturing and marketing of Metoprolol Telmisartan FDC. The nod was given by the Subject Expert Committee (SEC) Cardiovascular & Renal) in its recent meeting held on 07.01.2021 & 08.01.2021 at CDSCO HQ New Delhi.
The FDC drug contains Metoprolol (ER) + Telmisartan IP (IR) modified release bilayered tablet (25/25mg + 20/40mg)
Metoprolol is a selective β1 receptor blocker medication and used for the treatment of high BP, chest pain due to poor blood flow, and other conditions related to abonormally fast heart rate. The drug helps to block the action of certain natural chemicals in the body such as epinephrine. This, as a result, helps in lowering the heart rate.
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