Senores Pharma gets final approval for Metoprolol Tartrate and Hydrochlorothiazide tablets

Senores Pharmaceuticals announced that it has received final approval from the United States Food and Drug Administration (USFDA) to market Metoprolol Tartrate and Hydrochlorothiazide Tablet USP, 50 mg/25 mg and 100 mg/25 mg.

Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker, and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

According to IQVIA and Symphony sales data for the 12-month period ending November 2024, the Metoprolol Tartrate and Hydrochlorothiazide Tablet USP 50 mg/25 mg and 100 mg/25 mg markets achieved annual sales of approximately $ 6 million and $ 10 million, respectively, it added.

 

Senores' current portfolio includes 24 ANDA products that are permitted for distribution in the USA. In addition to these internal filings, Senores is actively seeking external development collaborations to augment and accelerate the growth of its existing pipeline and portfolio.

Swapnil Shah, MD, Senores Pharmaceuticals, said, We have been relentlessly working in enhancing our product portfolio, which includes a wide range of specialty and complex pharmaceutical products across various therapeutic areas in regulated markets, particularly in the US. Metoprolol Tartrate and Hydrochlorothiazide are specialized formulations with limited competition in the US, providing us an opportunity to capture a higher market share in this region.

Senores Pharmaceuticals is engaged in developing and manufacturing a wide range of pharmaceutical products predominantly for the regulated markets of the US, Canada, and the United Kingdom across various therapeutic areas and dosage forms, with a presence in emerging markets.

The company identifies and develops a diverse range of specialty, underpenetrated, and complex pharmaceutical products and manufactures critical care injectables and APIs. As of September 30, 2024, the company has launched 55 products in key therapeutic areas, including antibiotics and anti-fungal treatments.

The firm reported a consolidated net profit of Rs 23.94 crore and sales of Rs 181.02 crore for the six months ended on 30 September 2024.

Shares of Senores Pharmaceuticals declined 2.03% to currently trade at Rs 520 on the BSE.

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