Novugen has established itself as a leader in the development of complex generics and difficult-to-manufacture pharmaceutical products. These advanced products, while promising, come with significant challenges.
“One major challenge is the high risk of failure in clinical trials or bioequivalence studies due to the inherent complexity of these products. Navigating the diverse requirements and regulations set by various regulatory bodies and authorities adds another layer of complexity,” said Novugen Chief Executive Officer Rahil Mahmood.
The financial burden is also considerable. Developing these complex generics demands substantial capital investment, covering research, development, advanced manufacturing technologies, and regulatory compliance. Beyond financial challenges, the demand for highly skilled professionals and the need to maintain scientific competency significantly impact the feasibility and success of these endeavours.
Despite these obstacles, Novugen has made significant strides.
“Over the years, we have taken calculated risks to ensure early market access for complex products, providing patients with treatments when there are no robust alternatives available,” Rahil noted.
The company’s strategy has paid off, with several first-to-market products introduced in Malaysia and the US, reflecting their commitment to overcoming challenges and delivering innovative solutions.
GLOBAL COMPETITIVENESS IN R&D
In a rapidly evolving pharmaceutical landscape, innovation is vital to maintaining a competitive edge. Novugen’s approach to research and development (R&D) is both strategic and forward-thinking.
“We make significant investments in developing advanced and challenging products, particularly in high-value areas like oncology,” Rahil shared.
The company’s focus on complex therapeutic areas with substantial entry barriers positions it as a leader in pharmaceutical innovation.
“By leveraging cutting-edge technologies and investing in state-of-the-art platforms, Novugen aligns its R&D efforts with the future of healthcare.”
MALAYSIA’S STRATEGIC ROLE
Malaysia holds a central role in Novugen’s business strategy, serving as both its global R&D hub and a significant manufacturing base.
“We have strategically established Malaysia as our global R&D hub, equipped with a 40,000-square-foot R&D centre that employs over a hundred local scientists along with hundreds of other local professionals,” Rahil highlighted.
In addition to its R&D capabilities, Novugen operates two USFDA-approved manufacturing facilities in the country.
Looking ahead, Malaysia will continue to be pivotal to Novugen’s long-term strategy. The country is poised to be the company’s R&D and manufacturing hub for export markets, including the US, the largest pharmaceutical market in the world.
Novugen is committed to developing a comprehensive ecosystem in Malaysia by nurturing local talent, collaborating with third-party vendors, and expanding its manufacturing capacities.
“Our goal is to elevate Malaysia’s position on the global stage and ensure its integral role in our business strategy.”
IMPACT OF HALAL CERTIFICATION
For Novugen, halal certification is not just a compliance matter; it is a cornerstone of its market strategy.
“Halal certification significantly influences consumer trust by ensuring that our products comply with Islamic ethical standards,” Rahil asserted.
This certification builds strong loyalty among Muslim consumers and enhances market penetration in regions with substantial Muslim populations.
Novugen stands out as the first to have a USFDA-approved and halal-compliant manufacturing facility, a dual achievement that amplifies its commitment to quality and adherence to Islamic standards.
Rahil believes that this strategic positioning enables Novugen to tap into diverse consumer bases and strengthen our presence in international markets.
PIONEERING ONCOLOGY AND INNOVATIONS
Novugen has placed significant emphasis on oncology, a field that Rahil describes as one of the most dynamic and rapidly evolving fields in medical research.
“Cancer continues to be a leading cause of disease burden worldwide, partly due to changing lifestyles, increased stress levels, and global pollution. As the prevalence of cancer rises, there is a significant opportunity for pharmaceutical companies to develop and bring innovative treatments to the market.”
The company has focused its efforts on developing high-potent oncology drugs that address unmet needs in cancer treatment, contributing to the global fight against this devastating disease.
Looking forward, Novugen has ambitious plans.
“Over the next two to three years, we will be filing dossiers in various markets across Southeast Asia, the Middle East, Central Asia, Africa, Europe, Canada, and Australia.
“We are also forging strategic partnerships to leverage our R&D expertise in developing biosimilars and biologics,” Rahil shared.
The company is also advancing its capabilities in injectables and soft gels, and exploring new technologies. With a focus on staying at the forefront of pharmaceutical innovation, Novugen is poised to continue its growth and impact on a global scale. – 
@Halal
