Princeton, NJ June 10, 2026 –(PR.com)– Novugen Pharma (USA) LLC has launched Everolimus Tablets 2.5 mg, 5 mg, 7.5 mg, and 10 mg in the U.S. market, following the approval of its Abbreviated New Drug Application (ANDA) by the U.S. Food and Drug Administration (USFDA) in October 2025, further strengthening Novugen’s presence in a key global market.
Everolimus is indicated for hormone receptor-positive, HER2-negative breast cancer, neuroendocrine tumors (NET) associated with non-functional gastrointestinal or lung NET, and tuberous sclerosis complex (TSC)-related conditions. By offering a high-quality and more affordable alternative, Novugen aims to improve patient access to essential therapies while supporting continuity of care.
“This milestone is a true testament to the strength of our scientific and technical capabilities. Everolimus presents significant formulation and manufacturing challenges due to its low solubility, sensitivity to environmental conditions, and highly potent nature. Through advanced formulation expertise and optimized manufacturing strategies, our teams successfully developed a stable, bioequivalent, and affordable product that meets stringent global regulatory standards,” said Victor Borelli, Senior Vice President and Head of Commercial Operations, Novugen Pharma (USA) LLC.
“This launch reinforces our commitment to expanding access to high-quality, affordable oncology therapies and improving patient outcomes. We remain committed to challenging the status quo to broaden patient access to affordable treatments that help patients live better and longer lives,” he added.
Novugen’s Everolimus will be manufactured in Malaysia by Novugen Pharma Sdn. Bhd., home to the country’s first USFDA-approved and Southeast Asia’s only pharmaceutical and oncology manufacturing facilities specializing in oral solid dosage forms for both general medicines and highly potent oncology products.
About Novugen
Novugen is a wholly owned subsidiary of SciTech International, a UAE-based healthcare group with over 30 years of experience in building and scaling strategic healthcare businesses and world-class facilities globally. Backed by deep international expertise and a bold global strategy, Novugen is equipped to address the challenges of developing and commercializing innovative, hard-to-source, technology-intensive pharmaceutical products.
We specialize in innovative and complex generics across pharmaceutical and oncology therapies, consistently meeting stringent global quality standards. Our vertically integrated model—from active pharmaceutical ingredients (API), R&D, to finished dosage manufacturing in Malaysia—ensures strong supply chain control and operational excellence.
Contact Information:
Novugen Pharma Sdn. Bhd.
Li Anne Teo
+60 3 5870 2243
Contact via Email
https://novugen.com/
Find us on LinkedIn & Facebook at @novugen
Read the full story here: https://www.pr.com/press-release/970799
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