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HomePress ReleaseEIN PresswireOncogen Pharma (Malaysia) Sdn. Bhd. Received the First ANDA Approval for Abiraterone...

Oncogen Pharma (Malaysia) Sdn. Bhd. Received the First ANDA Approval for Abiraterone 250mg and 500mg Tablets


The product will be marketed by the group’s front end, Novugen Pharma (USA) LLC, which is based in Princeton, New Jersey.

SHAH ALAM, SELANGOR, MALAYSIA, January 28, 2022 /EINPresswire.com/ — Oncogen Pharma (Malaysia) Sdn. Bhd., the sister concern of Novugen Pharma (Malaysia) Sdn. Bhd. has been granted the first abbreviated new drug application (ANDA) approval by the US Food and Drug Administration (USFDA) for Abiraterone. The approved dosages include 250mg and 500mg tablets.

Abiraterone is indicated for the treatment of prostate cancer in men and is a type of hormone therapy. According to American Cancer Society, prostate cancer is the most common cancer in American men. The country’s 2022 projection shows about 268,490 new cases and approximately 34,500 deaths caused by the malignant. The market for Abiraterone is expected to be driven by the high incidence of prostate cancer globally.

The product approval has positioned Oncogen Pharma as the first pharmaceutical company in Malaysia to obtain an approval from the federal agency. The product will be marketed by the group’s front end, Novugen Pharma (USA) LLC, which is based in Princeton, New Jersey. This will advance the company to compete in the global landscape along with major players of Abiraterone market.

“We are very proud of this huge milestone not only for the company, but also the country. This product approval from USFDA is the first of many ANDA’s to come very soon. It is also the beginning for us to enter stringent global markets through our capabilities to develop, manufacture, and distribute technology intensive products that are latest in the line of treatment. Additionally, it demonstrates our strong passion to ensure patients in every corner of the world can access cost-effective medicine with a global quality standard product” said Rahil Mahmood, CEO of Oncogen Pharma and Novugen Pharma.

About Oncogen Pharma (Malaysia) Sdn. Bhd.

Oncogen Pharma (Malaysia) Sdn. Bhd. is a fully integrated research based pharmaceutical company with a global outlook to cancer treatment. Based in Malaysia, it is one of the fastest growing pharmaceutical company in the country with the largest portfolio of Oncology products under development. Oncogen Pharma has established the most advanced R&D facilities for developing Oncology APIs and formulations for regulated markets. The diversified and qualified technical team of top professionals from different parts of the world have deep experience & exposure of the development of strategic products for global markets.

Oncogen Pharma’s API and Formulation plants are set-up close to each other on over 8 acres of land in Enstek Park, Malaysia and are designed by international experts following stringent regulatory requirements by authorities across the globe including USFDA, EMA, PIC/S and WHO.

Website: www.oncogenpharma.com

About Novugen Pharma (Malaysia) Sdn. Bhd.

Novugen Pharma (Malaysia) Sdn. Bhd. is a wholly owned subsidiary company of a UAE based group with more than 25 years of experience in strategic healthcare businesses and development of world class healthcare facilities around the globe. Novugen Pharma’s globally minded strategy, synergistic approach and wealth of experience enable us to respond to the complex challenge of bringing hard-to-source and technology-intensive products to market while maintaining affordable pricing and rigorous quality assurance. As a technology leader, we create efficiency by integrating our total value chain. At Novugen Pharma, our science and business teams work together seamlessly to innovate new concepts and fresh ideas to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity.

Website: www.novugen.com

Corporate Affairs
Novugen Pharma (Malaysia) Sdn. Bhd.
+60 3-5561 8120
corpcomm@novugen.com
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