Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) for Paroxetine Extended-Release Tablets USP, 12.5 mg. The approved product is therapeutically equivalent to the reference listed drug, Paxil CR Tablets (12.5 mg), marketed by Apotex Inc Paroxetine extended-release tablets are prescribed for the treatment of multiple psychiatric conditions, including major depressive disorder (MDD), panic disorder (PD), social anxiety disorder (SAD), and premenstrual dysphoric disorder (PMDD).
This approval further strengthens Alembic’s presence in the regulated U.S. market and expands its portfolio of generic formulations. With this addition, the company now holds a cumulative total of 235 ANDA approvals from the USFDA, comprising 216 final approvals and 19 tentative approvals.
Alembic Pharmaceuticals is a vertically integrated research-driven pharmaceutical company with a legacy spanning more than a century. Headquartered in India, the company manufactures and markets a wide range of generic pharmaceutical products across global markets.
Its manufacturing and research facilities comply with stringent regulatory standards and are approved by leading global authorities, including the USFDA. Alembic has built a strong reputation in the branded generics segment in India, supported by a widespread field force of over 5,500 professionals.
The company continues to focus on expanding its product pipeline, strengthening its regulatory footprint, and enhancing its capabilities in complex generics and specialty segments. The latest approval reflects its ongoing commitment to delivering high-quality, affordable medicines to patients worldwide.
With a strong foundation in research, manufacturing excellence, and regulatory compliance, Alembic remains well-positioned to drive sustained growth in both domestic and international markets. Alembic Pharmaceuticals Limited is one of India’s oldest and most respected pharmaceutical companies, with a legacy that dates back to 1907. Headquartered in India, Alembic has built a strong global presence as a vertically integrated research-driven pharmaceutical company, focused on the development, manufacturing and marketing of high-quality generic medicines. The company operates across major therapeutic areas and supports healthcare systems worldwide through a wide portfolio of affordable formulations and active pharmaceutical ingredients.
A key strength of Alembic is its strong emphasis on research and development, backed by modern infrastructure and a consistent pipeline of new products for regulated and emerging markets. Its manufacturing facilities meet global standards and are approved by leading regulatory authorities, including the US Food & Drug Administration (USFDA). The company has secured a significant number of ANDA approvals in the United States, reflecting its capability in compliance-driven product development and execution.
In India, Alembic is also a leading player in branded generics, supported by a wide field force and a well-recognised set of brands trusted by healthcare professionals and patients. With a commitment to innovation, quality and patient-centric healthcare, Alembic continues to strengthen its role as a reliable pharmaceutical partner worldwide.
