Lupin gets U.S. FDA tentative approval for Generic Oxcarbazepine ER Tablets
Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oxcarbazepine Extended-Release (ER) Tablets in 150 mg, 300 mg, and 600 mg strengths.
These tablets are the generic equivalent of Oxtellar XR® ER Tablets by Supernus Pharmaceuticals and are indicated for the treatment of partial-onset seizures in patients aged 6 years and above. Lupin's version of the drug will be manufactured at its Nagpur facility in India.
According to IQVIA MAT April 2025 data, Oxcarbazepine ER Tablets (RLD Oxtellar XR®) recorded estimated annual sales of USD 206 million in the United States, underscoring the potential market opportunity for Lupin.
Headquartered in Mumbai, Lupin is a leading global pharmaceutical company with a strong footprint in the U.S. and India. The company focuses on a broad range of therapy areas including central nervous system disorders, respiratory, cardiovascular, anti-infective, and women's health. It operates 15 manufacturing sites and 7 research centers globally, supported by over 23,000 employees.
Lupin continues to expand its U.S. portfolio of complex generics and remains committed to delivering high-quality, affordable medicines that improve health outcomes for patients around the world.
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 BusinessUpturn.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Upturn
11 hours ago
- Business Upturn
Lupin gets U.S. FDA tentative approval for Generic Oxcarbazepine ER Tablets
Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oxcarbazepine Extended-Release (ER) Tablets in 150 mg, 300 mg, and 600 mg strengths. These tablets are the generic equivalent of Oxtellar XR® ER Tablets by Supernus Pharmaceuticals and are indicated for the treatment of partial-onset seizures in patients aged 6 years and above. Lupin's version of the drug will be manufactured at its Nagpur facility in India. According to IQVIA MAT April 2025 data, Oxcarbazepine ER Tablets (RLD Oxtellar XR®) recorded estimated annual sales of USD 206 million in the United States, underscoring the potential market opportunity for Lupin. Headquartered in Mumbai, Lupin is a leading global pharmaceutical company with a strong footprint in the U.S. and India. The company focuses on a broad range of therapy areas including central nervous system disorders, respiratory, cardiovascular, anti-infective, and women's health. It operates 15 manufacturing sites and 7 research centers globally, supported by over 23,000 employees. Lupin continues to expand its U.S. portfolio of complex generics and remains committed to delivering high-quality, affordable medicines that improve health outcomes for patients around the world. 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
13 hours ago
- Business Upturn
Afcons Infrastructure secures Rs 700 crore Vinyl Project contract from Reliance Industries
Afcons Infrastructure Limited has recently informed exchanges that the company received a Letter of Award (LoA) from Reliance Industries Limited (RIL) for the execution of construction works related to its Vinyl Projects at Dahej, Gujarat. This major development reinforces Afcons' strong presence in the infrastructure and engineering sector. The estimated contract value is approximately ₹700 crore, excluding GST. This figure is indicative, with payments to be made based on the actual value of the work executed as per the terms of the contract. The project is expected to be completed by the end of June 2026. As per the scope of the LoA, Afcons Infrastructure will undertake civil, mechanical, and associated construction works. The responsibilities also include installation, testing, and commissioning services as part of the comprehensive project package. This contract win reflects Afcons Infrastructure's continued partnership with leading corporates like Reliance Industries, highlighting its execution capabilities in large-scale industrial and infrastructure projects. In the meantime, Afcons Infrastructure shares closed at ₹435.00 on Friday, gaining modestly after opening at ₹425.95. The stock hit an intraday high of ₹437.50 and a low of ₹425.90. Despite recent volatility, Afcons remains above its 52-week low of ₹398.00, though still trading well below its 52-week high of ₹570.00. 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
13 hours ago
- Business Upturn
One Point to acquire majority stake in TECHSCIENT.AI for Rs 26 crore
By Aman Shukla Published on June 7, 2025, 14:03 IST One Point One Solutions Limited has announced the acquisition of a majority stake in Private Limited. The deal was approved by the Board of Directors on June 7, 2025, and involves the execution of a Securities Subscription and Purchase Agreement (SSPA) between the two companies and the shareholders of The acquisition will be completed in one or more tranches, subject to conditions outlined in the agreement. incorporated in September 2024, is an Indian company based in Bangalore. It operates in the artificial intelligence software sector, focusing on no-code automation and intelligent workflow orchestration. The company's platform combines generative AI, machine learning, and no-code development tools to simplify the automation of business processes. Its solutions are designed for domestic and international markets. The acquisition is not classified as a related-party transaction, and none of One Point One's promoter groups have any interest in The total consideration for the deal stands at ₹26 crore, including ₹15 crore for acquiring equity shares and ₹11 crore for subscribing to compulsorily convertible preference shares. On completion, One Point One will hold a 60.05% stake in on a fully diluted basis. This strategic move is intended to support One Point One's long-term digital transformation strategy. While operates in a different domain from the company's core business process management services, the acquisition is expected to enhance its capabilities in delivering AI-powered digital solutions and improve operational efficiency. The transaction is anticipated to close by September 30, 2025. 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
