Latest news with #Alembic
Business Upturn
4 days ago
- Business
- Business Upturn
Alembic Pharma receives EIR from USFDA for Karakhadi API-III facility
By Aman Shukla Published on June 18, 2025, 12:12 IST Alembic Pharmaceuticals has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its API-III manufacturing facility located in Karakhadi, Gujarat. The inspection was conducted between March 17 and March 21, 2025. The successful completion of the USFDA inspection and receipt of the EIR marks a significant regulatory milestone for Alembic, reinforcing the company's compliance with global quality standards. The API-III facility plays a key role in the production of active pharmaceutical ingredients (APIs) for Alembic's global markets. This development is expected to strengthen Alembic's position in the US market and support its ongoing growth in international formulations and API exports. In the meantime, Alembic Pharmaceuticals shares opened at ₹969.00 on Wednesday, and, at the time of writing, reached a high of ₹974.20 and a low of ₹953.10 during intraday trading. The stock remains significantly below its 52-week high of ₹1,303.90 but well above the 52-week low of ₹725.20. Ahmedabad Plane Crash 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
South Wales Argus
5 days ago
- Business
- South Wales Argus
Alembic Mediterranean tapas restaurant at Bristol Airport
Alembic, a new tapas restaurant, will officially open at Bristol Airport on July 3 in the departure lounge and offers a menu of small plates and sharing boards influenced by Mediterranean flavours. Dishes include Padron peppers, focaccia, Gambas al Ajillo, and Spanish meatballs, with a variety of vegetarian, vegan, and gluten-free options available. Kate Gwyther, head of retail at Bristol Airport, said: "We're really pleased to be able to add this premium experience for customers to enjoy in stylish and relaxing surroundings. "It's also great to be able to offer a completely different dining option whether it's brunch, lunch, or dinner, alongside some great South West drinks brands, which will also be available for customers to purchase from the World Duty Free store if they've tried something they like." The restaurant will offer Tapas-style food (Image: Bristol Airport) The restaurant aims to support regional producers and offers a selection of locally sourced drinks, including cocktails made with South West rum, gin, and whisky, as well as coffee from a regional supplier. For those flying out early, the breakfast menu features scrambled eggs on sourdough, bacon croissant rolls, Greek yoghurt, and Mediterranean options such as avocado on focaccia and shakshuka. Beth Brewster, senior coordinating director for Avolta F&B & Essentials, said: "This is our first opening at Bristol Airport, so a very proud moment for us. "We are also delighted to be introducing Alembic, as this is our second opening of this exciting new restaurant concept this year. "It showcases what we do brilliantly – creating delicious dishes using the best produce and complementing them with some locally sourced spirits and coffee. "We're confident that travellers visiting Bristol Airport are going to love Alembic's Mediterranean vibe, delicious food, and great customer service."
Business Upturn
30-05-2025
- 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.
