Alembic Pharmaceuticals Limited (Alembic) has announced a significant milestone in its product portfolio expansion. The company has received final approval from the US Food & Drug Administration (USFDA) for its Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL, in both single-dose and multiple-dose vial formats.

Key Highlights

• Product Approval: Triamcinolone Acetonide Injectable Suspension USP, 40 mg/mL
• Formats:
  • Single-Dose Vials: 200 mg/5 mL and 400 mg/10 mL
  • Multiple-Dose Vials: 40 mg/mL
• Reference Drug: Therapeutically equivalent to Bristol-Myers Squibb Company's Kenalog-40 Injectable Suspension
• Market Size: Estimated US$ 96.00 million for twelve months ending June 2025 (according to IQVIA)
• ANDA Approvals: Alembic now has a cumulative total of 227 ANDA approvals from USFDA

Product Details

The newly approved injectable suspension is indicated for various autoimmune, inflammatory, and other conditions where oral therapy is not feasible. This approval marks an important addition to Alembic's growing portfolio of pharmaceutical products in the US market.

Company's ANDA Portfolio

About Alembic Pharmaceuticals

Alembic Pharmaceuticals Limited, founded in 1907, is a vertically integrated research and development pharmaceutical company. The company's state-of-the-art research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. Alembic is recognized as one of the leaders in branded generics in India, with a field force of over 5,500 representatives.

This latest USFDA approval reinforces Alembic's commitment to expanding its presence in the US pharmaceutical market and enhancing its product offerings in the injectable segment. The approval of Triamcinolone Acetonide Injectable Suspension USP may contribute to the company's growth in the coming years, given the substantial market size for this product.

Alembic Pharmaceuticals Limited , a leading Indian pharmaceutical company, has achieved a significant milestone in its U.S. market expansion. The company announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Paroxetine Extended-Release Tablets in 25 mg and 37.5 mg strengths.

Key Highlights

• The approved Abbreviated New Drug Application (ANDA) is for Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg.
• These tablets are therapeutically equivalent to Apotex Inc.'s Paxil CR Extended-Release Tablets.
• The approval marks Alembic's 226th ANDA approval from the USFDA, including 205 final approvals and 21 tentative approvals.

Therapeutic Applications

The newly approved Paroxetine Extended-Release Tablets are indicated for the treatment of several mental health conditions:

• Major depressive disorder (MDD)
• Panic disorder (PD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD)

Company Profile

Alembic Pharmaceuticals Limited, established in 1907, is a vertically integrated research and development pharmaceutical company. The company has a strong presence in the Indian market and is expanding its global footprint, particularly in the United States.

Market Impact

This approval strengthens Alembic's position in the U.S. generic pharmaceuticals market. The company's growing portfolio of USFDA-approved products demonstrates its commitment to expanding its presence in key international markets.

Alembic Pharmaceuticals' shares are listed on the National Stock Exchange of India (NSE: APLLTD) and the Bombay Stock Exchange (BSE: 533573).

The approval of Paroxetine Extended-Release Tablets adds to Alembic's diverse product portfolio and may contribute to the company's revenue growth in the coming quarters. As always, patients should consult with their healthcare providers regarding the use of any new medication.