Zenara Pharma Gets FDA Approval for Generic Sertraline Capsules with 180-Day US Exclusivity

Zenara’s Final Approval for its New Capsules

Announcement

Zenara Pharma Private Limited, a pioneering biophore company, finally received approval from the FDA for its abbreviated new drug application (ANDA) named Sertraline Hydrochloride Capsules (SHC), 150 mg and 200 mg. It is the first-ever FDA-approved generic equivalent under consideration listed by Almatica Pharma, LLC.

This product has also received a competitive generic therapy (CGT) designation by the FDA. As the first approved applicant to this remarkable pathway, Zenara’s ANDA has secured 180 days of exclusive marketing in the US, effective from the date of its product launch.

Zenara’s Aim

The company, with its excellence in the development of drugs and commitment to provide safe and quality, and effective pharmaceuticals to patients, is leading ahead and progressing in the massive healthcare sector. With this approval of these products and allowance for marketization has paved the way for other pharmaceuticals to take a step ahead in adopting innovation and trial efforts into the health sector. The international promotion has accelerated the presence and awareness of the product and condition.

Need for SHC

The treatment for major depressive disorder is essential. Zenara's addressing this condition is a valuable contribution to adults and pediatric patients. In this highly competitive world, this drug is a next-generation solution for teens and adults. The medication for this condition and product use is available on prescription. It stabilizes mental health and improves sleep, also the relaxation for busy individuals is mostly neglected. These capsules promote relaxation. The intensified research and development on this capsule led to FDA approval and the marketing in the US. The Zenara is now a qualified leader in major depressive disorder treatment. The company will continue to update and work towards developing at a competitive level soon.

New Drug’s Specialization

The sertraline hydrochloride capsules are differentiated as selective serotonin reuptake inhibitors (SSRIs) and are referred for the major depressive disorder (MDD) treatment mainly in obsessive-compulsive disorder (OCD) and adults, including pediatric patients aged six years and older. The IQVIA™ sales data witnessed in the year ending June 2025, the US sales of the recommended product reached $35.5 million.

Views and Statements

CEO of Zenara Pharma Pvt. Ltd., Dr. Srinivas Arutla, said, “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 best to patients best with high-quality, early, and affordable pharmaceuticals.”