Latest news with #AbbreviatedNewDrugApplication
Business Standard
16 hours ago
- Business
- Business Standard
Medicamen Biotech rallies after securing USFDA approval for Bortezomib injection
Medicamen Biotech soared 5.39% to Rs 440 after the company has received its first Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (USFDA) for Bortezomib for injection 3.5 mg. The ANDA pertains to Bortezomib for Injection, 3.5 mg single-dose vial. The USFDA has determined that the product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Velcade for Injection, 3.5 mg/vial, marketed by Takeda Pharmaceuticals U.S.A. Inc. (NDA-021602). This milestone marks a significant step forward in the companys strategy to enter regulated markets. The Bortezomib API was developed in-house through the companys R&D efforts and manufactured at Shivalik Rasayan, which holds USDMF 036171. The achievement underscores Medicamens capabilities in successfully developing and commercializing products using its own R&D and API manufacturing infrastructure, built over the past few years. It also highlights the companys strong commitment to stringent quality standards, robust regulatory compliance, and adherence to Current Good Manufacturing Practices (cGMP). Medicamen reaffirmed its dedication to maintaining the integrity of its products and systems as it continues to expand its footprint in the U.S. market. Medicamen Biotech is a research-led pharmaceutical company involved in developing, manufacturing, and marketing generic finished dosage formulations, and Oncology Formulations. The companys consolidated net profit rose 13.6% to Rs 2.42 crore in Q4 FY25, despite a 37.4% decline in revenue from operations to Rs 29.61 crore compared to the year-ago period.
Business Upturn
17 hours ago
- Business
- Business Upturn
Medicamen Biotech secures USFDA nod for Bortezomib injection, marks its first ANDA approval
By Aditya Bhagchandani Published on June 3, 2025, 12:56 IST Medicamen Biotech Limited announced on June 3, 2025, that it has received its first Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (USFDA) for Bortezomib for Injection, 3.5 mg single-dose vial. This marks a critical milestone in the company's journey to expand into regulated markets, particularly the United States. The product is found to be bioequivalent and therapeutically equivalent to Velcade for Injection, a drug marketed by Takeda Pharmaceuticals U.S.A., Inc. The API (Active Pharmaceutical Ingredient) for the product was developed in-house and manufactured at Shivalik Rasayan, which holds a valid USDMF (Drug Master File No. 036171). The approval strengthens Medicamen Biotech's vertically integrated product portfolio and is a testament to its robust R&D capabilities and commitment to regulatory compliance and cGMP standards. The company emphasized that this achievement reflects its growing focus on global markets and quality-driven manufacturing. 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.
Business Upturn
2 days ago
- Business
- Business Upturn
Zydus receives tentative USFDA approval for Rifaximin Tablets, 550 mg
By Aman Shukla Published on June 2, 2025, 08:12 IST Zydus Lifesciences Limited, along with its subsidiaries and affiliates (collectively referred to as 'Zydus'), has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rifaximin Tablets, 550 mg. The approved product is a generic version of Xifaxan® Tablets, 550 mg, which is indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. The tablets will be manufactured at the company's SEZ II facility in Ahmedabad, India. According to IQVIA MAT data for March 2025, Rifaximin Tablets, 550 mg, recorded annual sales of approximately USD $2,672.9 million in the U.S. market. With this tentative approval, Zydus now has a total of 427 ANDA approvals. Since beginning its ANDA filings in the financial year 2003–04, the company has submitted 492 ANDAs to date. 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
4 days ago
- Business
- Business Standard
Alembic Pharma receives USFDA final approval for Bosutinib tablets
Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bosutinib Tablets. Bosutinib tablets are indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who have shown resistance or intolerance to prior therapy. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Bosulif Tablets, marketed by PF Prism C.V. (Pfizer). According to IQVIA, Bosutinib Tablets have an estimated market size of $ 291 million for the twelve months ending March 2025. Alembic has a cumulative total of 223 ANDA approvals (200 final approvals and 23 tentative approvals) from USFDA. Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. The companys consolidated net profit declined 12% to Rs 156.89 crore despite a 16.7% jump in net sales to Rs 1,769.64 crore in Q4 FY25 over Q4 FY24. The counter rose 0.97% to Rs 1,015.30 on the BSE.
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Business Standard
23-05-2025
- Business
- Business Standard
What drove Indoco Remedies share price 6% higher today? Top details inside
Indoco Remedies share price: Pharmaceutical company Indoco Remedies shares rose as much as 6.38 per cent to hit an intraday high of Rs 258.20 per share on Friday, May 23, 2025. At 12:10 PM, Indoco Remedies share price was trading 1.77 per cent higher at Rs 247. In comparison, BSE Sensex was trading 0.90 per cent higher at 81,678.93 level. Why did Indoco Remedies share price rise? Indoco Remedies share price rose after the company announced that it has secured final approval of Allopurinol Tablets USP, 200 mg through Company's Abbreviated New Drug Application (ANDA) for Allopurinol Tablets USP to market a generic equivalent to the reference listed drug (RLD), Zyloprim 200 mg of Casper Pharma LLC from USFDA.' Allopurinol is used to prevent or lower high uric acid levels in the blood. It is also used to prevent or lower excess uric acid levels caused by cancer medicines or in patients with kidney stones. Aditi Panandikar, managing director of Indoco Remedies, said, 'Besides reflecting the capability of Indoco Remedies to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the US.' The product will be manufactured by Indoco Remedies Limited at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India, the company revealed. About Indoco Remedies Indoco Remedies is a fully integrated, research-driven pharmaceutical company with a robust global footprint. With a turnover of approximately $180 million, the company is supported by a talented workforce of over 6,000 employees, including more than 400 scientists and an extensive field force. These professionals form the backbone of Indoco's operations, driving innovation and ensuring the delivery of high-quality pharmaceutical products. The company operates 11 state-of-the-art manufacturing facilities—seven dedicated to finished dosage forms (FDFs) and four for active pharmaceutical ingredients (APIs)—along with a cutting-edge R&D centre and a Contract Research Organization (CRO) facility. These facilities are approved by major global regulatory agencies, including the USFDA and UKMHRA. Indoco serves both domestic and international markets, generating over 106 million prescriptions annually through a network of more than 2,40,000 doctors across various specialties. Domestically, it operates through 10 marketing divisions and offers a strong brand portfolio spanning multiple therapeutic areas such as gastroenterology, respiratory care, anti-infectives, ophthalmology, nutrition, cardiology, diabetology, pain management, and gynecology. Some of Indoco's flagship brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, and Glychek. Globally, Indoco partners with leading generic pharmaceutical companies, further strengthening its presence in international markets.
