KUALA LUMPUR, December 27 – Novugen Oncology Sdn. Bhd. has marked a historic achievement in Malaysia’s pharmaceutical landscape by securing approval from the U.S. Food and Drug Administration (USFDA) for its manufacturing facility specializing in high-potency oncology drugs. The milestone positions Novugen as Malaysia’s first and Southeast Asia’s only company with USFDA-approved facilities for pharmaceutical and oncology manufacturing, emphasizing the nation’s capability to produce advanced pharmaceuticals locally. The approval aligns with Novugen’s commitment to positioning Malaysia as a manufacturing hub for technology-intensive pharmaceutical and oncology products.
The USFDA approval, obtained just a year after Novugen’s initial accreditation for oral solid dosage forms, signifies a significant leap forward for the Malaysian pharmaceutical industry. Datuk Wira Arham Abdul Rahman, CEO of the Malaysian Investment Development Authority (MIDA), lauded Novugen’s achievement, emphasizing its contribution to strengthening Malaysia’s position in the global value chain and supporting long-term resilience and sustainability. Novugen’s entry into the U.S. market with two approved products, Abiraterone and Midodrine tablets, demonstrates the company’s commitment to providing high-quality medicines that meet stringent USFDA requirements.
Dr. Madan Mulukuri, Senior Vice President, Quality Operations of Novugen, highlighted the company’s focus on creating a sustainable ecosystem of highly skilled talents in the local pharmaceutical industry. As Novugen advances towards becoming a multi-product facility, it emphasizes training and collaboration with local universities to foster world-class manufacturing expertise. Novugen’s USFDA-approved facilities not only reduce import dependency but also position Malaysia as a key player in pharmaceutical exports, especially to the U.S., showcasing the nation’s capacity for innovation and excellence in pharmaceutical and oncology sectors.
