Latest news with #Indoco
Business Upturn
3 days ago
- Business
- Business Upturn
Indoco Remedies gets USFDA nod for generic Rivaroxaban tablets; eyes growth in US Market
Mumbai-based Indoco Remedies Ltd. has secured final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) to market Rivaroxaban Tablets USP in strengths of 2.5 mg, 10 mg, 15 mg, and 20 mg. The product is the generic equivalent of Janssen Pharmaceuticals' blockbuster anticoagulant, Xarelto, and will be manufactured at Indoco's Verna, Goa facility. The approved Rivaroxaban tablets are bioequivalent and therapeutically equivalent to Xarelto and are indicated for the treatment of venous thromboembolism (VTE). This approval marks another milestone in Indoco's push into the US generics market, one of the most lucrative pharmaceutical markets globally. Commenting on the development, Indoco Remedies' Managing Director Aditi Panandikar 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.' Indoco Remedies is a fully integrated, research-driven pharmaceutical company with a global footprint, generating over 106 million prescriptions annually in India alone. The company operates 11 manufacturing facilities — seven for finished dosage forms (FDFs) and four for active pharmaceutical ingredients (APIs) — all of which are approved by top global regulatory agencies including the USFDA and UK-MHRA. With a turnover of $180 million and a workforce of more than 6,000 employees, Indoco is known for popular domestic brands such as Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, and Cital. Internationally, the company partners with large generics players to expand its market reach across multiple geographies. The latest USFDA approval strengthens Indoco's product portfolio in the regulated market and could open up significant revenue opportunities as Rivaroxaban continues to be a widely prescribed oral anticoagulant in the US. Disclaimer: This news article is for informational purposes only and does not constitute investment advice. Investors should consult a qualified financial advisor before making investment decisions. Ahmedabad Plane Crash 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
3 days ago
- Business
- Business Upturn
Why are Indoco Remedies shares up 2% today? Explained
By Aditya Bhagchandani Published on August 13, 2025, 10:05 IST Indoco Remedies Ltd shares climbed over 2% to ₹299.30 in morning trade on Tuesday after the company announced it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Rivaroxaban tablets, a generic version of Bayer's blockbuster anticoagulant Xarelto. The approval covers multiple dosage strengths — 2.5 mg, 10 mg, 15 mg, and 20 mg — positioning Indoco to tap into the lucrative US market for blood thinners, which has significant demand due to rising cardiovascular cases. Industry data shows Rivaroxaban sales in the US crossed $2 billion in recent years. Indoco said the launch will be executed through its marketing partner in the US, adding that this development strengthens its complex generics portfolio and enhances its revenue visibility in the American market. The stock's rally reflects investor optimism about the earnings potential from this launch, given that US generics typically offer higher margins than domestic formulations. Disclaimer: This article is for informational purposes only and does not constitute financial advice. Investing in equities involves risks. Please consult a certified financial advisor before making any investment decisions. Ahmedabad Plane Crash 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.
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Business Standard
24-07-2025
- Business
- Business Standard
Indoco Remedies rises 6% on EU GMP certificate, trims gains after Q1 show
Indoco Remedies share price: Shares of pharmaceutical company Indoco Remedies were in focus on Thursday, July 24, 2025, with the scrip rising as much as 5.99 per cent to an intraday high of ₹328.65 per share. By 12:41 PM, Indoco Remedies shares had pared some gains, and were trading 4.18 per cent higher at ₹323 after weak Q1 results. In comparison, the BSE Sensex was down 0.64 per cent at 82,198.32 levels. Indoco Remedies gets EU GMP Compliance certificate Earlier in the day, Indoco Remedies had announced that it has received a Certificate of EU Good Manufacturing Practices (GMP) Compliance from the European Health Authorities for its sterile drug product manufacturing facility at Goa Plant II. "The EU GMP certification issued by the European Health Authorities confirms that the site complies with the Good Manufacturing Practice requirements," the company said. Aditi Panandikar, managing director, Indoco Remedies, said, 'This GMP certification for our sterile drug product manufacturing facility, Goa Plant II is a testament to our relentless efforts to supply quality and affordable medicines across geographies. We remain fully committed to adhering to cGMP standards and consistently delivering quality products to customers and patients worldwide.' Indoco Remedies Q1 results Indoco Remedies posted a disappointing set of numbers for the June quarter of financial year 2026 (Q1FY26). Indoco Remedies reported a net loss of ₹35.6 crore in Q1FY26, compared to a profit of ₹2.6 crore in the same period last year (Q1FY25). Revenue rose marginally (1.5 per cent) year-on-year (Y-o-Y) to ₹438 crore in the June quarter of FY26, from ₹431.5 crore in the June quarter of FY25. Operational performance took a major hit. Ebitda, also known as operating performance, declined 63.3 per cent Y-o-Y to ₹17.5 crore, as against ₹47.8 crore in the same quarter a year ago, while margins contracted to 4 per cent in Q1FY26, from 11.1 per cent in Q1FY25. About Indoco Remedies Indoco Remedies is a fully integrated, research-driven pharmaceutical company with a strong global footprint. With a turnover of $180 million and a workforce of over 6,000 employees – including more than 400 skilled scientists and field staff – the company is built on a foundation of scientific excellence and operational strength. The company operates 11 manufacturing facilities, comprising seven for finished dosage forms (FDFs) and four for active pharmaceutical ingredients (APIs), supported by a state-of-the-art R&D center and a contract research organization (CRO). These facilities are approved by key global regulatory bodies such as the USFDA and UK-MHRA, enabling Indoco to cater to both domestic and international markets. The company commands a strong presence in the Indian market with over 106 million prescriptions generated annually by more than 2,40,000 doctors across various specialties. Indoco has 10 domestic marketing divisions and a robust brand portfolio spanning multiple therapeutic segments including gastrointestinal, respiratory, anti-infectives, ophthalmology, cardiovascular, pain management, and more. Leading brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, and Cital. On the global front, Indoco Remedies has forged strategic partnerships with several major generic companies, further strengthening its position in regulated and emerging markets alike.
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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.
