Novugen Oncology Sdn. Bhd. has become the company in Malaysia and Southeast Asia to be granted approval by the U.S. Food and Drug Administration (USFDA) for its manufacturing facility specialising in high potent oncology drugs.
The sought-after approval by the U.S. federal agency came just a year after the company’s first USFDA approval for Novugen Pharma Sdn. Bhd., focusing on oral solid dosage forms for general medicines. With these approvals, the pharmaceutical company becomes the first in the country and the only in the Southeast Asia region to be accredited by the USFDA for pharmaceutical and oncology manufacturing facilities to produce affordable and high-quality medicines for the U.S. market, from Malaysia.
Novugen has shown promising signs for their future as the company commercialised two products in the U.S. with Abbreviated New Drug Application (ANDA) approval from USFDA for Abiraterone 250mg and 500mg tablets and Midodrine 2.5mg, 5mg and 10mg. The successful launch of the two products in the U.S. marks the commencement of Novugen’s journey towards unveiling future phases of a comprehensive range of life-changing medicines, designed to benefit millions of patients while meeting the stringent USFDA requirements.
The approved manufacturing facilities play a major role in advancing the nation’s pharmaceutical industry and healthcare sector by reducing the dependency on imports and ensuring self-sufficiency in manufacturing and supplying high-quality products, especially those with elaborate formulations that lack robust generic alternatives. It also fortifies Malaysia’s capacity to export and enter the world’s largest economy and market – the U.S. – for pharmaceutical and oncology product sectors.
