Novugen Oncology Earns USFDA Approval for High-Potency Drug Manufacturing in Malaysia

January 2024

Malaysian pharmaceutical company, Novugen Oncology Sdn Bhd has secured approval from the US Food and Drug Administration (USFDA) for its specialized manufacturing facility focusing on high-potency oncology drugs. Novugen as the first and only entity in Malaysia and Southeast Asia to be recognized by the USFDA for pharmaceutical and oncology manufacturing facilities.

The USFDA approval comes within a year of Novugen Pharma Sdn Bhd’s initial accreditation. Novugen has successfully commercialized two products in the US, namely Abiraterone 250mg and 500mg tablets and Midodrine 2.5mg, 5mg, and 10mg, with Abbreviated New Drug Application (ANDA) approval from the USFDA.

This approval aligns with Novugen’s aim to positioning Malaysia as a manufacturing hub for technologically advanced pharmaceutical and oncology products. In terms of future prospect, the company emphasizes employee training in advanced containment principles and technologies, as it evolves into a multi-product facility with increasing complexity.

(Sources: Novugen; New Straits Times)

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