Senores Pharmaceuticals Receives USFDA Approval for Key Hypertension Drug

Senores Pharmaceuticals Limited, headquartered in Ahmedabad, India, has achieved a significant milestone with the United States Food and Drug Administration (USFDA) granting final approval for the marketing of its Metoprolol Tartrate and Hydrochlorothiazide Tablet USP. This drug will be available in two combinations: 50 mg/25 mg and 100 mg/25 mg.

This product combines Metoprolol Tartrate, a beta-blocker, and Hydrochlorothiazide (HCTZ), a thiazide diuretic. It is primarily used for the treatment of hypertension, which helps lower blood pressure and reduces the risk of cardiovascular events, including strokes and heart attacks.

The share price of Senores Pharma is down by 1.72% as of 10:56 AM on 10 January 2025.

The Market Opportunity

According to data from IQVIATM and Symphony, the market for Metoprolol Tartrate and Hydrochlorothiazide Tablets in the US saw annual sales of approximately $6 million and $10 million for the two dosage variants, respectively, during the 12 months ending November 2024. With limited competition in this category, Senores is well-positioned to capture a substantial share of this market.

Building a Diverse Portfolio

This approval adds to Senores Pharmaceuticals’ growing portfolio of 24 Abbreviated New Drug Applications (ANDAs) permitted for distribution in the United States. The company is actively pursuing external collaborations to accelerate the growth of its product pipeline, focusing on specialty and complex pharmaceutical formulations across various therapeutic areas.

A Commitment to Regulated Markets

“We are continuously enhancing our product portfolio with specialty and niche pharmaceutical products for regulated markets, especially the US,” said Swapnil Shah, Managing Director of Senores Pharmaceuticals Limited. He highlighted the company’s focus on developing products with limited competition, providing opportunities to strengthen its presence in the US market.

About Senores Pharmaceuticals

Senores Pharmaceuticals Limited is a global pharmaceutical company focused on developing and manufacturing specialty and complex products for regulated and emerging markets. Its subsidiary, Senores Pharmaceuticals, Inc., based in Georgia, USA, is among the fastest-growing pharmaceutical companies in the US.

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