Windlas Biotech Gets CDSCO Panel Nod To study Bisoprolol Fumarate, Telmisartan, Chlorthalidone FDC

New Delhi: Windlas Biotech has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence study of the fixed-dose combination (FDC) cardiovascular drug Bisoprolol Fumarate plus Telmisartan plus Chlorthalidone IP(2.5mg/5mg/10mg + 20mg/40mg/80mg + 6.25mg/12.5mg/12.5mg) uncoated tablets.

This came after the firm presented the proposal along with the amended bioequivalence (BE) study protocol.

Bisoprolol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve and decrease blood pressure. Bisoprolol blocks beta-1 receptors in your heart. These receptors normally bind to hormones called catecholamines. When catecholamines bind to these receptors, it causes your heart to beat harder and faster. Blocking these receptors helps your heart beat more slowly. These effects can help lower blood pressure and may reduce your risk of heart attack and stroke.

Telmisartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.

Telmisartan is used alone or in combination with other medications to treat high blood pressure. Telmisartan is also used to decrease the chance of heart attack, stroke, or death in people 55 years of age or older who are at high risk for cardiovascular disease

Chlorthalidone is in the sulfamoylbenzamide class. As it lacks the benzothiadiazine structure of the thiazide-type diuretics, it is called a thiazide-like diuretic. Chlorthalidone is a diuretic medication that treats high blood pressure. It also treats swelling caused by heart, kidney, or liver disease. It works by helping your kidneys remove fluid and salt from your blood through your pee.

At the recent SEC meeting for Cardiovascular held on 5th March 2025, the expert panel reviewed the proposal along with the amended BE protocol.

After detailed deliberation, the committee recommended granting permission to conduct the BE study as per the presented amended BE protocol.

Accordingly, the expert panel suggested that the firm should submit a BE study report along with a Phase-III CT protocol to CDSCO for further review by the committee.

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