Alembic Pharma gains as USFDA approves Macitentan tablets for pulmonary arterial hypertension
Shares of Alembic Pharmaceuticals Ltd were in focus on Tuesday, August 19, after the company announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Macitentan Tablets, 10 mg.
The product is a generic version of Actelion Pharmaceuticals' Opsumit tablets and is indicated for the treatment of pulmonary arterial hypertension (PAH) in adults to reduce the risk of disease progression and hospitalization. According to IQVIA data, the drug has an estimated market size of $1.18 billion for the 12 months ending June 2025.
With this nod, Alembic's cumulative USFDA approvals now stand at 224 Abbreviated New Drug Applications (ANDAs), including 203 final approvals and 21 tentative approvals. The approval adds to the company's growing US generics portfolio, which has been a key driver of international business.
Founded in 1907, Alembic is a vertically integrated pharmaceutical company with a strong presence in branded generics in India and a well-established footprint in the global generics market. The company manufactures and markets products across multiple therapeutic segments through its R&D-driven operations.
Disclaimer: This article is for informational purposes only and should not be construed as investment advice.
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.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
2 hours ago
- Business Wire
VASTHERA Receives U.S. FDA Clearance to initiate Phase 1 Clinical Trial of Pulmonary Arterial Hypertension Drug Candidate, VTB-10
SEOUL, South Korea--(BUSINESS WIRE)--On August 6, 2025, VASTHERA Co., Ltd. announced that it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for VTB-10, its drug candidate for pulmonary arterial hypertension (PAH), a rare, life-threatening disease marked by elevated blood pressure in the lung arteries. VTB-10 is a first-in-class drug candidate developed using VASTHERA's proprietary Redoxizyme™ platform. VASTHERA identified a deficiency of the enzyme peroxiredoxin (PRX) in PAH lesions and developed VTB-10, a small molecule enzyme (Chemzyme) that precisely replicates PRX function. In preclinical studies, VTB-10 reversed abnormal vascular remodeling and restored functional endothelium. These dual effects clearly differentiate it from existing therapies. This milestone follows the FDA's designation of VTB-10 as an Orphan Drug (ODD) in November 2024, enabling VASTHERA to formally begin global clinical development. The program has been supported by national funding from the Korea Drug Development Fund (KDDF). Dr. Sang Wong Kang, Ph.D., CEO of VASTHERA, stated, 'The U.S. clinical entry of VTB-10 marks a major milestone, demonstrating VASTHERA's technological competitiveness in PAH treatment and reinforcing the global credibility of Korean biotech ventures. Through upcoming clinical trials, we aim to deliver an innovative treatment that can significantly improve quality of life for PAH patients.' Dr. Sang Wong Kang is an expert in redox regulation of cellular signaling since his early research at the NIH/NHLBI, has dedicated more than two decades to building the scientific foundation of the Redoxizyme™ platform. Since PRX deficiency is implicated in multiple diseases, this platform holds broad potential for developing novel therapeutics across various indications, supporting sustainable growth and long-term value creation in the global market. VASTHERA is building up its Redoxizyme™-based pipeline with VTB-10 as the cornerstone, and the initiation of the Phase 1 clinical study will mark a significant step in the evolution of its VASTHERA's pipeline portfolio with global potential.
Business Upturn
5 hours ago
- Business Upturn
INDIA bloc names ex-Supreme Court judge B. Sudarshan Reddy as Vice-Presidential candidate
By Aditya Bhagchandani Published on August 19, 2025, 13:06 IST Leaders of the INDIA bloc on Tuesday announced former Supreme Court judge B. Sudarshan Reddy as their candidate for the Vice-Presidential election scheduled for September 9. The announcement came after a huddle at Congress chief Mallikarjun Kharge's residence, where opposition leaders deliberated on fielding a common nominee. The move pits the Opposition against the BJP-led NDA, which on Sunday named Maharashtra Governor C.P. Radhakrishnan as its candidate. Radhakrishnan, a veteran of the Rashtriya Swayamsevak Sangh (RSS) and former president of the BJP's Tamil Nadu unit, is expected to be backed unanimously by the ruling alliance. Defence Minister Rajnath Singh had earlier reached out to opposition leaders, including Kharge, in an attempt to build support for a consensus choice, though the INDIA bloc ultimately decided to field its own nominee. The election was necessitated after Vice President Jagdeep Dhankhar resigned last month citing health reasons. The last date for filing nominations is August 21. The contest is expected to be closely watched, though the NDA holds a numerical advantage in the electoral college. In the last Vice-Presidential election, the Opposition fielded Margaret Alva, who lost to Dhankhar. The majority mark stands at 394 in the combined strength of both Houses of Parliament, which totals 786 members. Justice Reddy, who also served as the first Lokayukta of Goa, is being projected as a consensus and non-political choice, reflecting the Opposition's strategy to nominate a respected figure from outside active politics. 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
7 hours ago
- Business Upturn
Alembic Pharma gains as USFDA approves Macitentan tablets for pulmonary arterial hypertension
By Aditya Bhagchandani Published on August 19, 2025, 11:18 IST Shares of Alembic Pharmaceuticals Ltd were in focus on Tuesday, August 19, after the company announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Macitentan Tablets, 10 mg. The product is a generic version of Actelion Pharmaceuticals' Opsumit tablets and is indicated for the treatment of pulmonary arterial hypertension (PAH) in adults to reduce the risk of disease progression and hospitalization. According to IQVIA data, the drug has an estimated market size of $1.18 billion for the 12 months ending June 2025. With this nod, Alembic's cumulative USFDA approvals now stand at 224 Abbreviated New Drug Applications (ANDAs), including 203 final approvals and 21 tentative approvals. The approval adds to the company's growing US generics portfolio, which has been a key driver of international business. Founded in 1907, Alembic is a vertically integrated pharmaceutical company with a strong presence in branded generics in India and a well-established footprint in the global generics market. The company manufactures and markets products across multiple therapeutic segments through its R&D-driven operations. Disclaimer: This article is for informational purposes only and should not be construed as investment advice. 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.
