Novugen – Southeast Asia’s First Vertically Integrated Pharma Company Gets USFDA Approval For Its Manufacturing Facility

On 22 November 2022, Novugen Pharma Sdn. Bhd. received the U.S. Food and Drug Administration (USFDA) approval for its general pharmaceutical manufacturing facility in Bandar Enstek, Negeri Sembilan. In addition to being Southeast Asia’s first vertically integrated pharmaceutical company, from active pharmaceutical ingredient (API) to finished dosage products, this makes Novugen Malaysia’s first pharmaceutical company to receive an approval from the federal agency and the only in the region. This approval will allow Novugen to export solid oral formulations to the US market from its state-of-the-art manufacturing facility.

From UAE to Malaysia and the world

Novugen was established in 2015 as a wholly owned subsidiary company of a United Arab Emirates (UAE) – based group SciTech International. Driven by the mission to challenge the status quo, Novugen develops high barrier medicines to enhance the quality of life worldwide. Novugen carries a unique portfolio specialising in all therapeutic areas of general medicine and leading potent molecules for the treatment of various conditions in the niche field of oncology and immunomodulatory products.

Novugen established its footprint in Southeast Asia with its first API research and development (R&D) centre which was completed in 2015, spreading across 40,000 square feet. In 2017, the company’s first containment R&D centre for oncology drugs was built as part of its ambition to be the first vertically integrated pharmaceutical company in Malaysia. This has contributed to promoting the worldwide export of prescription medicine, which in turn places Malaysia on the global map of pharmaceuticals.

Rahil Mahmood, CEO of Novugen

Strategically located in the heart of Southeast Asia, Malaysia offers robust business connectivity as a getaway to regional markets of over 670 million people. SciTech International also considered Thailand and Indonesia. However, Malaysia was selected upon considering the factors that outweigh the other two countries namely ease of operation, quality of infrastructure and availability of a diverse and skilled workforce.

Being an active trading nation with multiple international trade agreements, Malaysian Government authorities — including the Malaysian Investment Development Authority (MIDA) —have been a strong support base for Novugen to build the company’s foundation and manufacturing plants – bringing innovative and advanced technology to the nation’s pharmaceutical industry.

Competitive advantage drives global ambitions

As construction on the Bandar Enstek manufacturing facility began in 2017, the facility was audited by Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) in 2020, after which the company received the manufacturing license approval from NPRA in the same year. Novugen’s product filing for the U.S. started in April 2022 from its facility in Malaysia and received the approval for its finished product oral solid dosage facility in November 2022 from USFDA.

Rahil Mahmood, CEO of Novugen said, “Novugen has a competitive advantage compared to other pharmaceutical companies in Malaysia, as we possess three decades of global experience from our parent company, SciTech International. With knowledge and experience transfer as well as high capital resources, we were able to invest in constructing our state-of-the-art manufacturing facility to meet USFDA stringent requirements, right from the beginning.”

“It is a moment of great pride to become the first pharmaceutical company in Malaysia and the only in Southeast Asia to achieve this accreditation. This signifies our long-term vision to be a major player in the U.S. market and enables us to launch our boutique portfolio of complex products into the U.S., to cater to unmet patient needs,” he said.

In addition to Novugen’s highly skilled talents, the company benefits from a global standard infrastructure, strong R&D, as well as regulatory affairs capabilities. This latest USFDA accreditation will also amplify the company’s potential to penetrate other highly regulated markets, including Canada, Europe and Australia, Mahmood explained.

More products in the pipeline

In the coming months, Novugen aims to accelerate the launch of four products in the pipeline for the U.S., in phases until the last quarter of 2023. Novugen has a pipeline of over 25 Abbreviated New Drug Applications (ANDA) and growing, which are in the filing and late-stage development phase.

Leveraging on the USFDA approved manufacturing facility in Bandar Enstek, Novugen is capable of expediting its product reviews, resulting in serving patients in the U.S. faster with high quality affordable medicine.

With a vision to be the largest and fastest growing pharmaceutical company in Southeast Asia by 2025, competing in global markets, Novugen is committed to the long-term support of economic growth for Malaysia by creating local job opportunities.

Novugen employs more than 500 professionals today, including international scientists and medical experts, collaborating with Malaysia’s local talent to conduct complex R&D operations. By 2030, Novugen is projected to grow its workforce to more than 5,000 employees worldwide.