Alembic Pharmaceuticals Limited has secured final approval from the US Food and Drug Administration (USFDA) for its Paroxetine Extended-Release Tablets USP in 25 mg and 37.5 mg strengths. This approval is an important milestone for Alembic, expanding its portfolio in the US pharmaceutical market and reinforcing its commitment to providing high-quality generic medicines globally.
USFDA Approval Details
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Alembic Pharmaceuticals received USFDA final approval for Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg.
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These tablets are therapeutically equivalent to the reference listed drug, enabling Alembic to compete effectively in the US market.
Product Significance
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Paroxetine is a widely prescribed selective serotonin reuptake inhibitor (SSRI) used primarily for treating depression, anxiety disorders, and other mental health conditions.
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The extended-release formulation improves patient compliance by providing controlled drug release over time.
Market and Strategic Impact
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The approval enables Alembic to strengthen its presence in the lucrative US generics market.
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Alembic continues to build its portfolio of approved Abbreviated New Drug Applications (ANDAs), which currently stand above 220, reflecting its strong R&D and regulatory capabilities.
Company Outlook
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Alembic’s consistent focus on USFDA approvals underlines its growth strategy in the global pharmaceutical arena.
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The company’s modern manufacturing facilities and compliance with stringent regulatory standards support sustained expansion.
Sources: Alembic Pharmaceuticals Official Press Release, USFDA Approval Regulatory Documents, Market Reaction and Analysis