Latest news with #Alembic
Business Upturn
3 days ago
- Business
- Business Upturn
Alembic Pharmaceuticals shares in focus after USFDA nod for cancer drug Bosutinib
By Aditya Bhagchandani Published on May 30, 2025, 12:04 IST Shares of Alembic Pharmaceuticals may be in focus after the company announced that it has received final approval from the US Food & Drug Administration (USFDA) for its generic Bosutinib Tablets in 100 mg and 500 mg strengths. Bosutinib is indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant or intolerant to prior therapy. According to IQVIA data, the estimated market size for Bosutinib Tablets in the US stood at USD 291 million for the twelve months ending March 2025. Alembic stated that the approved product is therapeutically equivalent to Bosulif Tablets, originally marketed by PF Prism C.V. With this latest nod, Alembic has received a cumulative total of 223 ANDA approvals from the USFDA, comprising 200 final approvals and 23 tentative approvals. This development reinforces Alembic's commitment to expanding its oncology portfolio in the US 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
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 Standard
15-05-2025
- Business
- Business Standard
Alembic Pharmaceuticals receives USFDA approval for Rivaroxaban 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) Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xarelto Tablets, 2.5 mg, 10 mg, 15 mg, and 20 mg, of Janssen Pharmaceuticals, Inc. (Janssen). Rivaroxaban tablets, 2.5mg, are indicated: i) to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD), ii) to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD. Refer label for a detailed indication. According to IQVIA, Rivaroxaban Tablets USP, 2.5 mg, has an estimated market size of US$ 445 million for twelve months ending March 2025 and Alembic will be launching this strength in Q1FY26. The estimated market size for remaining strengths of Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg, is US$ 8,052 million for twelve months ending March 2025 according to IQVIA.
Business Standard
14-05-2025
- Business
- Business Standard
Alembic consolidated net profit declines 5.13% in the March 2025 quarter
Sales rise 22.90% to Rs 60.27 crore Net profit of Alembic declined 5.13% to Rs 68.45 crore in the quarter ended March 2025 as against Rs 72.15 crore during the previous quarter ended March 2024. Sales rose 22.90% to Rs 60.27 crore in the quarter ended March 2025 as against Rs 49.04 crore during the previous quarter ended March 2024. For the full year,net profit rose 15.66% to Rs 310.68 crore in the year ended March 2025 as against Rs 268.62 crore during the previous year ended March 2024. Sales rose 40.89% to Rs 221.89 crore in the year ended March 2025 as against Rs 157.49 crore during the previous year ended March 2024. Particulars Quarter Ended Year Ended Mar. 2025 Mar. 2024 % Var. Mar. 2025 Mar. 2024 % Var. Sales 60.2749.04 23 221.89157.49 41 OPM % 45.3549.25 - 42.2336.11 - PBDT 29.6725.71 15 166.13110.53 50 PBT 26.9224.23 11 155.50102.69 51 NP 68.4572.15 -5 310.68268.62 16
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Business Standard
06-05-2025
- Business
- Business Standard
Alembic Pharma Q4 profit dips 12%, revenue rises 17% to Rs 1,770 cr
Vadodara-based Alembic Pharmaceuticals posted a 12 per cent year-on-year drop in net profit for the fourth quarter of the 2024–25 financial year to Rs 157 crore as its net sales increased by 17 per cent to Rs 1,770 crore. The Ebitda was up 9 per cent to Rs 286 crore, with a resulting Ebitda margin of 16 per cent. Profit before tax rose 5 per cent to Rs 192 crore. The company took some write-offs on impaired assets in previous years, which had brought down the taxation, clarified R K Baheti, group CFO, Alembic. Shaunak Amin, MD, Alembic Pharmaceuticals, said that the India-branded business displayed improved performance backed by specialty therapies. 'Our Ex-US business delivered strong growth of 43 per cent across all markets, whereas the US business grew 20 per cent during the quarter,' he added. Alembic has been focusing on markets like the EU, Canada, Australia, and Latin American countries for the last two years, and this has now yielded results, Baheti said, adding that the US still contributes around 60 per cent of their Rs 1,200 crore international generics business. In the coming quarters, the company plans to grow its US business too. The India-branded business grew 8 per cent to Rs 545 crore for the quarter, during which it made four launches in Q4FY25 and 14 launches in total for the year. The animal health business grew 19 per cent for the quarter. Alembic saw a 4 per cent growth in its active pharmaceutical ingredients (API) business for the quarter, but the API business declined 9 per cent for the full year to Rs 1,133 crore. 'We lost some large customers due to pricing competition. We have started working on that, and expect that the API business will be back on the growth path in FY26,' Baheti said.
