Alembic Pharma Gets USFDA Nod for Paroxetine ER Tablets

The approval pertains to the company’s supplemental Abbreviated New Drug Application (sANDA) for the antidepressant formulation, which is therapeutically equivalent to the reference listed drug Paxil CR Tablets, 12.5 mg, marketed by Apotex Inc.

Paroxetine extended-release tablets are indicated for the treatment of multiple psychiatric conditions, including Major Depressive Disorder (MDD), Panic Disorder (PD), Social Anxiety Disorder (SAD), and Premenstrual Dysphoric Disorder (PMDD), as per the approved labeling.

With this latest approval, Alembic Pharmaceuticals has further expanded its regulatory footprint in the United States. The company now holds a cumulative total of 235 ANDA approvals from the USFDA, comprising 216 final approvals and 19 tentative approvals.

Headquartered in Vadodara, Alembic Pharmaceuticals is a vertically integrated research and development-driven pharmaceutical company with a legacy dating back to 1907. The company is publicly listed and manufactures as well as markets generic pharmaceutical products across global markets.

Alembic’s manufacturing and research facilities are approved by several global regulatory authorities, including the USFDA. In India, the company is among the leading players in the branded generics segment, supported by a strong field force of over 5,500 personnel and a wide portfolio of recognized brands among healthcare professionals and patients.

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