Novugen Pharma Became the First Pharmaceutical Company in Malaysia to Receive USFDA Approval for Its Manufacturing Facility

The Company was audited in September 2022 and USFDA issued an Establishment Inspection Report (EIR) in November 2022. Novugen Pharma is the first USFDA approved pharmaceutical manufacturing in Malaysia and the only in Southeast Asia.

Novugen Pharma Became the First Pharmaceutical Company in Malaysia to Receive USFDA Approval for Its Manufacturing Facility
Bandar Enstek, Malaysia, November 22, 2022 --( Southeast Asia’s first vertically integrated pharmaceutical company, Novugen Pharma Sdn. Bhd., received U.S. Food and Drug Administration (USFDA) approval for its general pharmaceutical manufacturing facility in Bandar Enstek, Negeri Sembilan, Malaysia. This accreditation marks the country's first pharmaceutical company to receive an approval from the federal agency and the only in Southeast Asia.

This approval will allow Novugen Pharma to export solid oral formulations to the US market from its state-of-the-art manufacturing facility. Novugen Pharma’s manufacturing facility started its site construction in 2017 and was audited by Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) in 2020 after which received the manufacturing license approval from NPRA in the same year. The Company’s product filing for the US 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.

“Novugen Pharma 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,” said Rahil Mahmood, CEO of Novugen.

“It is a moment of great pride to become the first 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 US market and enables us to launch our boutique portfolio of complex products into the US, to cater to unmet patient needs. The employees of Novugen Pharma are key in achieving this accreditation as well as sustaining the USFDA approval, which will be a key success factor for Novugen Pharma in the long run. People across all functions play a significant role of developing and adhering to the stringent procedures and practices to meet the high-quality standards we have set for our products,” said Rahil Mahmood.

“Complementary to our highly skilled talents, are the global standard infrastructure, strong R&D as well as Regulatory Affairs capabilities,” he added. This accreditation will also amplify the Company’s potential to penetrate other highly regulated markets, including Canada, Europe and Australia.

In the coming months, Novugen Pharma aims to accelerate the launch of four products in pipeline for the US, 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 approval for Novugen Pharma manufacturing facility, the Company is capable of expediting their product reviews, resulting in serving patients in the US faster with high quality affordable medicine.
Novugen Pharma Sdn. Bhd.
Syazwan Saufi
+60 3 5870 2243
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