Latest news with #Ticagrelor
Business Upturn
5 days ago
- Business
- Business Upturn
Indoco Remedies launches Ticagrelor tablets in UK through subsidiary
By Aditya Bhagchandani Published on June 3, 2025, 13:06 IST Indoco Remedies Limited has officially launched its Ticagrelor film-coated tablets (90mg) in the United Kingdom through its subsidiary, Indoco Remedies UK Limited, on June 2, 2025. This marks a significant development for the company as it expands its international portfolio in the antiplatelet medication segment. The newly launched product is aimed at reducing the risk of heart attacks, strokes, and other cardiovascular complications. It will be marketed and distributed across the UK by Clarity Pharma. Commenting on the development, Aditi Kare Panandikar, Managing Director of Indoco Remedies, said, 'This development underscores our commitment to bringing high quality, life-saving treatments to patients in the UK.' Indoco Remedies is a fully integrated pharmaceutical company with a global presence and a turnover of USD 180 million. The company has 11 manufacturing facilities and over 6,000 employees. It operates in various therapeutic segments, including gastrointestinal, respiratory, anti-infectives, and cardiovascular care, among others. The UK launch of Ticagrelor further strengthens Indoco's footprint in the international market and reinforces its commitment to expanding its presence in regulated markets. Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information. Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
The Hindu
02-05-2025
- Health
- The Hindu
Alembic Pharma's generic Ticagrelor tablets gets U.S. FDA nod
Alembic Pharmaceuticals has received U.S. Food and Drug Administration final approval for an abbreviated new drug application for Ticagrelor Tablets 90 mg and tentative approval for Ticagrelor Tablets 60 mg. The approved ANDA is therapeutically equivalent to the reference listed drug Brilinta Tablets, 60 mg and 90 mg, of AstraZeneca. Ticagrelor tablets are indicated to reduce the risk of cardiovascular death, myocardial infarction (MI) and stroke in patients with acute coronary syndrome or a history of MI. For Ticagrelor Tablets 90 mg, Alembic was one of the first to submit a substantially complete ANDA with a paragraph IV certification. The estimated market size of Ticagrelor Tablets 90 mg was $1,062 million for twelve months ending March 2025. Ticagrelor Tablets 60 mg had an estimated market size of $242 million during the same period, the company said citing IQVIA numbers. The tablet is also indicated to reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS; to reduce risk of a first MI or stroke in patients with coronary artery disease; and to reduce the risk of stroke in patients with acute ischemic stroke.
Business Standard
02-05-2025
- Health
- Business Standard
Alembic Pharmaceuticals receives USFDA final approval for Ticagrelor Tablets
Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Brilinta Tablets, 60 mg and 90 mg, of AstraZeneca Pharmaceuticals LP (AstraZeneca). Ticagrelor tablets are indicated for: i) to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. ii) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events, and iii) to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score <5) or high-risk transient ischemic attack (TIA). For Ticagrelor Tablets, 90 mg, Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification. Ticagrelor Tablets, 90 mg have an estimated market size of US$ 1,062 million for twelve months ending March 2025 according to IQVIA. Ticagrelor Tablets, 60 mg have an estimated market size of US$ 242 million for twelve months ending March 2025 according to IQVIA.
Business Upturn
02-05-2025
- Business
- Business Upturn
Alembic Pharma gets USFDA final nod for Ticagrelor 90 mg, tentative approval for 60 mg
Alembic Pharmaceuticals Limited announced on May 2, 2025, that it has received final approval from the US Food and Drug Administration (USFDA) for its Ticagrelor Tablets, 90 mg, and tentative approval for Ticagrelor Tablets, 60 mg. The 90 mg dosage has been approved as a therapeutically equivalent generic to AstraZeneca's Brilinta, and is indicated to reduce the risk of cardiovascular death, myocardial infarction (MI), stroke, and stent thrombosis in certain high-risk patients. The 60 mg variant has also received tentative approval pending patent expiry or exclusivity clearance. Alembic was among the first ANDA applicants to file for the 90 mg dosage with a Paragraph IV certification, indicating it is contesting the innovator's patent. According to IQVIA data, the estimated market size in the U.S. for the 90 mg Ticagrelor tablets is approximately US$ 1,062 million, and for the 60 mg tablets is around US$ 242 million, for the twelve months ending March 2025. With this development, Alembic's cumulative USFDA approvals now stand at 222 ANDAs, comprising 197 final approvals and 25 tentative approvals. The company reaffirmed its long-standing focus on regulated markets, with robust R&D and vertically integrated manufacturing capabilities. Alembic continues to expand its presence in global generics with a strong pipeline and established regulatory track record. News desk at
