Zenara Pharma Private Limited, a leading Biophore company, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Capsules (150 mg and 200 mg). This marks the first-ever FDA-approved generic equivalent of the reference drug listed by Almatica Pharma, LLC.
The product has also been granted Competitive Generic Therapy (CGT) designation by the FDA. As the first approved applicant through this designation, Zenara has secured 180 days of exclusive marketing rights in the United States, effective from the product’s commercial launch.
Addressing Mental Health with Affordable Solutions
Sertraline Hydrochloride, a selective serotonin reuptake inhibitor (SSRI), is primarily prescribed for the treatment of major depressive disorder (MDD) and obsessive-compulsive disorder (OCD) in adults and pediatric patients aged six and above. The medication plays a critical role in improving mood, promoting relaxation, and enhancing quality of life especially in today’s fast-paced world where mental well-being is often neglected.
According to IQVIA™ sales data, U.S. sales of the branded reference product reached approximately $35.5 million for the 12-month period ending June 2025, highlighting strong market potential for Zenara’s newly approved generic.
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A Milestone in Innovation and Access
This FDA approval not only reinforces Zenara’s strength in research and development but also represents a significant advancement in providing cost-effective mental health treatments. The company views this milestone as a major step in its mission to deliver safe, high-quality, and affordable pharmaceuticals to global markets.
Leadership Insight
Dr. Srinivas Arutla, CEO of Zenara Pharma, expressed pride in the achievement, stating:
“The first generic approval for sertraline hydrochloride capsules spotlights Zenara’s robust R&D potential and operational excellence. We are committed to our mission of serving patients with high-quality, early, and affordable pharmaceuticals.”
Looking Ahead
Zenara continues to expand its global footprint and aims to play a leading role in advancing healthcare through innovation. The successful approval and market exclusivity of Sertraline Hydrochloride Capsules positions the company as a key player in the treatment of major depressive disorders and supports its ongoing commitment to mental health solutions.
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