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Novugen is Malaysia’s first & Southeast Asia’s only USFDA-approved oncology plant to produce drugs for US market

Novugen is Malaysia’s first & Southeast Asia’s only USFDA-approved oncology plant to produce drugs for US market

04 Dec 2023

Novugen Oncology Sdn Bhd (Novugen) has received approval by the US Food and Drug Administration (USFDA) for its manufacturing facility specialising in high potent oncology drugs. 

The approval is part of Novugen’s commitment to promote Malaysia as a manufacturing hub to produce technology intensive pharmaceutical and oncology products locally. 

The approval came just a year after the company’s first approval from USFDA for Novugen Pharma Sdn Bhd. 

These approvals marked Novugen as the first in the country and the only in Southeast Asia region to be accredited by the USFDA for pharmaceutical and oncology manufacturing facilities to produce affordable and high-quality medicines for the US market, from Malaysia. 

“We congratulate Novugen for their achievement in securing USFDA approval for their high potent oncology drug manufacturing facility. 

“This accomplishment is nothing short of phenomenal, as it significantly strengthens the Malaysian pharmaceutical industry by enhancing its capabilities and technological expertise to produce complex pharmaceutical products.”

Movement added that it aligned with Mission 1 of the New Industrial Master Plan (NIMP) 2030 to establish advanced economic complexity in the high technology manufacturing of complex products and services. 

“Beyond this, it not only strengthens Malaysia’s position within the global value chain but also reaffirms our commitment to long-term resilience and sustainability,” said Malaysian Investment Development Authority chief executive officer Datuk Wira Arham Abdul Rahman. 

The company commercialised two products in the US with Abbreviated New Drug Application (ANDA) approval from USFDA for Abiraterone 250mg and 500mg tablets and Midodrine 2.5mg, 5mg and 10mg. 

Novugen quality operations senior vice president Dr Madan Mulukuri said the company is focused on training its current employees in elaborate containment principles and technologies as the company becomes a multi-product facility with growing complexity. 

“We leverage our current collaborations with local universities offering programs for undergraduates to acquire world-class manufacturing expertise and competencies. 

“Ultimately, our mission is to create access for the Malaysian workforce to get acquainted with intricate pharmaceutical operations and be exposed to stringent global regulations to create a sustainable ecosystem of highly skilled talents in the local pharmaceutical industry,” he said.

Source: NST