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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Telmisartan is an angiotensin II receptor blocker (ARB) and is another useful drug for treating high blood pressure.
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Emcure Pharmaceuticals Limited presented their proposal for the marketing and manufacturing of FDC of Metoprolol (ER) + Telmisartan IP (IR) modified release bilayered tablet (25/25mg + 20/40mg) before the CDSCO panel. The firm also submitted the BE study report along with their proposal.
SEC, in its s 83rd meeting, held on 07.01.2021 & 08.01.2021 at CDSCO HQ New Delhi reviewed the proposal of Emcure Pharmaceuticals minutely.
After detailed deliberation, Committee recommended for grant of permission for manufacturing and marketing of FDC of s (-) Metoprolol (ER) + Telmisartan IP (IR) modified release bilayered tablet (25/25mg + 20/40mg)
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