Zydus receives final approval from the USFDA for 7 products

Zydus receives final approval from the USFDA for 7 products

Zydus Cadila has received the final approval from the USFDA to market Valsartan and Hydrochlorothiazide Tablets USP (US RLD – Diovan HCT Tablets) in the strengths of 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg. The drug is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. The group now has 256 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04.

Sitagliptin and Metformin Hydrochloride Tablets

Zydus Cadila has received the tentative approval from the USFDA to market Sitagliptin and Metformin Hydrochloride Extended-Release Tablets, (US RLD – JANUMET® XR), 50 mg/500 mg, 50 mg/1,000 mg and 100 mg/1,000 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. It contains two oral antidiabetic medications used in the management of type 2 diabetes – sitagliptin and metformin hydrochloride extended-release. The group now has 255 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04.

Potassium Chloride Extended-Release Capsules USP

Zydus Cadila has received the final approval from the USFDA to market Potassium Chloride Extended-Release Capsules USP (US RLD – Micro-K® Extended-Release Capsules), 8 mEq (600 mg) and 10 mEq (750 mg). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Some conditions that can lower the body’s potassium level include severe prolonged diarrhoea and vomiting, hormone problems such as hyperaldosteronism, or treatment with ‘water pills’/diuretics. The group now has 254 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04.

Atenolol and Chlorthalidone Tablets USP

Zydus Cadila has received the final approval from the USFDA to market Atenolol and Chlorthalidone Tablets USP (US RLD – Tenoretic®), 50 mg/25 mg and 100 mg/25 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. Atenolol belongs to a class of drugs known as beta blockers. It works by blocking the action of certain natural chemicals in your body, such as epinephrine on the heart and blood vessels. This effect lowers the heart rate, blood pressure and strain on the heart. Chlorthalidone is a ‘water pill’ (diuretic) and causes the body to get rid of extra salt and water. It also helps to relax the blood vessels so that blood can flow easily. The group now has 253 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.