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

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Bandar Enstek, Malaysia, November 22, 2022 –(PR.com)– 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…

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