Granules India Receives USFDA Nod for Antidepressant Tablets

Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of Granules India, has recently achieved a significant milestone in the pharmaceutical industry by receiving approval from the U.S. Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Bupropion hydrochloride extended-release tablets. This approval is crucial for the company's expansion in the regulated markets of the United States.

Overview of Bupropion Hydrochloride Extended-Release Tablets

Bupropion hydrochloride extended-release tablets are primarily prescribed for the treatment of major depressive disorder and the prevention of seasonal affective disorder. This medication is recognized for its effectiveness and is often chosen for patients who require long-term management of these conditions.

The approved formulation is bioequivalent and therapeutically equivalent to GlaxoSmithKline LLC's Wellbutrin SR sustained-release tablets, which are available in three dosages: 100 mg, 150 mg, and 200 mg. This approval underscores the product's alignment with established standards for efficacy and safety, as it meets the requirements set forth by the U.S. Food and Drug Administration (USFDA).

Granules India's Milestone Achievement

With the recent approval of Bupropion hydrochloride extended-release tablets, Granules India has now achieved a total of 67 ANDA approvals from the US FDA. This accomplishment highlights the company's ongoing commitment to expanding its footprint in regulated markets. The successful approval process showcases Granules India's dedication to maintaining the highest standards in pharmaceutical manufacturing and ensuring the availability of quality medications to patients in need.

Insights from Company Leadership

Dr. Krishna Prasad Chigurupati, the Chairman and Managing Director of Granules India, expressed his satisfaction with the ANDA approval. He stated, "This ANDA approval marks a significant milestone in our journey to expand Granules' presence in the U.S. market. Our continued focus on expanding our product portfolio in regulated markets like the U.S. ensures that we are meeting the growing healthcare needs of patients globally while maintaining the highest standards of safety and efficacy." Dr. Chigurupati's comments reflect the company’s strategic vision for growth and its commitment to addressing healthcare challenges on a global scale.

Granules India's Business Focus

Granules India is primarily engaged in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs). The company’s diverse product portfolio enables it to cater to various market needs and positions it favorably within the competitive pharmaceutical landscape.

Financial Performance Highlights

Granules India has reported strong financial performance in recent quarters. For the first quarter of FY25, the company recorded a consolidated net profit of ₹134.65 crore, marking a substantial increase from ₹47.89 crore in the corresponding quarter of the previous year (Q1 FY24). Additionally, revenue from operations for the same quarter reached ₹1,179.87 crore, reflecting a remarkable 19.72% growth compared to ₹985.52 crore a year earlier. These financial results underscore the effectiveness of Granules India's business strategies and its ability to capitalize on growth opportunities in the pharmaceutical sector.

Market Reaction to the Approval

Following the announcement of the USFDA approval, Granules India's shares experienced a slight increase, closing 0.11% higher at ₹595.10 apiece on the Bombay Stock Exchange. This positive market response indicates investor confidence in the company's future prospects, particularly in light of the recent regulatory milestone.

Conclusion

The USFDA approval of Bupropion hydrochloride extended-release tablets is a significant achievement for Granules India, reinforcing its commitment to delivering high-quality pharmaceuticals to meet the healthcare needs of patients. With a strong product portfolio and a focus on regulated markets, Granules India is well-positioned for continued growth and success in the competitive pharmaceutical industry. The leadership's dedication to expanding the company’s presence in the U.S. market reflects its proactive approach to addressing global healthcare challenges and ensuring patient access to effective medications.