Alembic Pharmaceuticals Limited (Alembic) has achieved a significant milestone in its US market expansion strategy. The company announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ticagrelor Tablets, 60 mg.

Key Highlights

• Alembic Pharma received USFDA final approval for Ticagrelor Tablets, 60 mg
• The approved ANDA is therapeutically equivalent to AstraZeneca's Brilinta Tablets, 60 mg
• Ticagrelor Tablets have an estimated market size of US$ 236 million for twelve months ending June 2025
• Alembic's US sales have reached $236 million

Product Details

Ticagrelor tablets are indicated for several cardiovascular conditions:

1. Reducing the risk of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction
2. Reducing the risk of stent thrombosis in ACS patients who have been stented
3. Reducing the risk of a first myocardial infarction or stroke in patients with coronary artery disease at high risk
4. Reducing the risk of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack

Market Impact

The approval of Ticagrelor Tablets, 60 mg, opens up a significant market opportunity for Alembic. According to IQVIA data, the estimated market size for this drug is US$ 236 million for the twelve months ending June 2025. This approval complements Alembic's previous final approval for Ticagrelor Tablets, 90 mg, further strengthening its cardiovascular product portfolio.

Alembic's ANDA Approvals

With this latest approval, Alembic has achieved a cumulative total of 227 ANDA approvals from the USFDA, including:

Company Overview

Alembic Pharmaceuticals Limited, founded in 1907, is a vertically integrated research and development pharmaceutical company. The company specializes in manufacturing and marketing generic pharmaceutical products globally. Alembic's state-of-the-art research and manufacturing facilities have received approvals from regulatory authorities of many developed countries, including the USFDA.

In India, Alembic is recognized as one of the leaders in branded generics, with a field force of over 5,500 representatives marketing its well-recognized brands to doctors and patients.

This latest USFDA approval for Ticagrelor Tablets reinforces Alembic's commitment to expanding its presence in the US generic pharmaceutical market and demonstrates its capabilities in developing complex generic formulations.

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.