JB Chemicals receives USFDA approval for market generic medication

JB Chemicals receives USFDA approval for market generic medication

In a significant development, JB Chemicals & Pharmaceuticals has achieved a noteworthy milestone by obtaining approval from the prestigious US health regulatory authority. This green signal allows the company to introduce a generic pharmaceutical product aimed at managing mood disorders within the expansive American pharmaceutical market.

The esteemed US Food and Drug Administration (USFDA) has officially granted JB Chemicals & Pharmaceuticals the authorization to market Doxepin Hydrochloride capsules. These capsules will be available in a range of strengths, specifically 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg, as detailed in the regulatory disclosure by the company.

This groundbreaking product from JB Chemicals & Pharmaceuticals serves as the generic counterpart to Pfizer’s renowned Sinequan capsules. Notably, these capsules are indicated for addressing a spectrum of mental health concerns, including anxiety, depression, and other pivotal symptoms associated with psychoneurosis.

Manufacturing of this pivotal drug is slated to take place at JB Chemicals & Pharmaceuticals’ advanced formulation manufacturing facility located in Panoli, Gujarat.

An insightful overview of IQVIA MAT data reveals that the estimated annual sales of Doxepin Hydrochloride capsules in the US market amounted to a substantial USD 23.90 million.

Market sentiment mirrors this accomplishment as JB Chemicals’ shares experienced an encouraging surge of 3.86 percent, reaching Rs 2,754.90 per share in trading on the BSE.

About JB Chemicals:

J B Chemicals and Pharmaceuticals Ltd (JBCPL) is one of India’s fastest growing pharmaceutical companies. An integrated, research-oriented, public listed organisation with a focus on supplying affordable, quality products both in India and International markets, JBCPL is trusted by healthcare professionals globally.

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