Alembic Pharmaceuticals has secured the USFDA Final Approval for its Paroxetine Extended-Release Tablets USP, 12.5 mg. This product is therapeutically equivalent to the reference listed drug, Paxil CR Tablets. The drug is indicated for treating conditions including Major Depressive Disorder (MDD) and Social Anxiety Disorder (SAD). This marks another key milestone, bringing Alembic’s cumulative USFDA approvals to 235 total.
USFDA Final Approval Secured
Alembic Pharmaceuticals Limited announced on 27th March, 2026, that it has successfully received Final Approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) covering Paroxetine Extended-Release Tablets USP, 12.5 mg.
Product Equivalence and Indications
The approved sANDA product is therapeutically equivalent to the reference listed drug product (RLD), Paxil CR Tablets, 12.5 mg, originally manufactured by Apotex Inc. Paroxetine extended-release tablets are indicated for the treatment of several psychological conditions, including Major Depressive Disorder (MDD), Panic disorder (PD), Social Anxiety Disorder (SAD), and Premenstrual Dysphoric Disorder (PMDD).
Pipeline Achievement Milestone
This approval further strengthens Alembic’s presence in the US generic market. The company highlighted that, including this latest clearance, Alembic has achieved a cumulative total of 235 ANDA approvals from the USFDA. This total comprises 216 final approvals and 19 tentative approvals, showcasing the sustained productivity of its research and manufacturing capabilities.
Company Background
Alembic Pharmaceuticals Limited is a vertically integrated pharmaceutical company with a heritage dating back to 1907. Headquartered in India, the company is publicly listed and focuses on manufacturing and marketing generic pharmaceutical products globally. Alembic’s facilities are approved by major regulatory authorities, including the USFDA, and the company maintains a strong position in the Indian branded generics market, supported by a field force of over 5500 personnel.
Source: BSE
