Latest news with #AlembicPharmaceuticalsLimited
Business Upturn
23-05-2025
- Business
- Business Upturn
Alembic Pharmaceuticals gets USFDA final approval for Amlodipine and Atorvastatin Tablets
By Aman Shukla Published on May 23, 2025, 12:01 IST Alembic Pharmaceuticals Limited has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amlodipine and Atorvastatin Tablets USP. The approved product includes a range of dosage combinations: 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg. These formulations are therapeutically equivalent to Caduet Tablets, the reference listed drug (RLD) marketed by Pharmacia and Upjohn Co. LLC. Amlodipine and Atorvastatin Tablets are prescribed for patients who require treatment with both medications. The drug combines a calcium channel blocker and a statin to manage conditions such as high blood pressure and high cholesterol. The approval by the USFDA allows Alembic to market these tablets in the United States. With this approval, Alembic now has a total of 223 ANDA approvals from the USFDA, including 199 final approvals and 24 tentative approvals. About Alembic Pharmaceuticals Limited Alembic Pharmaceuticals Limited is an India-based pharmaceutical company involved in the development, manufacture, and marketing of generic pharmaceutical products. Established in 1907, the company is headquartered in Vadodara, Gujarat. Alembic operates research and manufacturing facilities that are approved by regulatory agencies including the USFDA and markets its products globally. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
Business Upturn
15-05-2025
- Business
- Business Upturn
Alembic Pharma gets USFDA nod for Rivaroxaban tablets across four strengths; to launch 2.5 mg in Q1 FY26
By Aditya Bhagchandani Published on May 15, 2025, 13:42 IST Alembic Pharmaceuticals Limited announced on May 15 that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets USP in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths. These tablets are therapeutically equivalent to Xarelto, a product marketed by Janssen Pharmaceuticals, Inc., and are used to reduce the risk of major cardiovascular and thrombotic vascular events in patients with coronary artery disease (CAD) and peripheral artery disease (PAD). The company plans to launch the 2.5 mg strength in the first quarter of FY26. According to IQVIA, the estimated market size for the 2.5 mg dosage in the U.S. is $445 million for the 12 months ending March 2025, while the market size for the 10 mg, 15 mg, and 20 mg strengths collectively stands at $8,052 million. With this approval, Alembic now holds a cumulative total of 222 ANDA approvals, which includes 198 final approvals and 24 tentative approvals from the USFDA. Alembic Pharmaceuticals, headquartered in Vadodara, India, is a vertically integrated pharmaceutical company engaged in manufacturing and marketing of generic drugs globally. The company has over 5,200 field personnel and a well-established brand presence in the Indian generics market. 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. 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.
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
