Novugen collaborates with physicians and health experts around the world to develop products that address the greatest patient needs. Targeting all major therapeutic categories, we focus our efforts on non-infringing product development processes, off-patent products and difficult-to-develop niche molecules, making them more accessible than ever to patients across the globe.

Integrated R&D Center

In 2018, Novugen became the first and only Malaysian company to have filed ANDA with USFDA, launching a new phase in the region’s pharmaceutical industry. With international and local multi-disciplinary in-house scientists and expertise in pharmaceutical R&D development, our teams specialize in creating alternate and patentable processes for generic formulations which are acceptable to regulatory agencies globally.

We are equipped for these formulation development processes:
  • Product and process optimization
  • Reverse engineering
  • Analytical method development
  • Analytical method validation
  • Evaluation and techno-marketing studies
  • Technology transfer

Novugen has the capability to develop unique modified-release products like pellets, MUPS and targeted-release formulations.

Regulatory Affairs

Novugen’s R&D is supported by an in-house Intellectual Property (IP) management team with in-depth knowledge and expertise in non-infringement analysis, invalidation strategies, patent filing as well as early market entry and First-to-File (FTF) generic opportunities. Our network of local attorneys in key regions provide further assurances in addition to our comprehensive database of patent landscape for challenging markets.

Our in-house regulatory affairs group maintains relationships with Ministries of Health and regulatory bodies around the world ensuring that Novugen’s products and procedures satisfy all country-by-country regulatory practices and mandatory compliances to enable efficient product registrations.

Academic Partnership

We believe our partnerships with academic institutions and knowledge networks not only improve innovation at Novugen but also strengthen our relationship with the community, where the students gain valuable real-world experience and our staff have the opportunity to develop their coaching and mentoring skills with potential new hires.

In addition, Novugen extends invitations to graduate and post-graduate science students to participate in our internship program, which promotes industry-institute interaction and harnesses the fresh perspectives of some of the field’s newest entrants.

R&D Facilities

Novugen’s investment in advanced technologies and equipment demonstrate our dedication to becoming a technology leader in our product portfolio. From the beginning, our leading-edge R&D center has the capacity to develop multiple pharmaceutical products each year, continuously improving the breadth and depth of our offerings.

We are dedicated to implementing and innovating best practices in all we do. Our Analytical and Formulation Labs are staffed by a team of experts committed to ensuring excellence through precise testing procedures and maintaining stringent standards. We insist on Good Documentation Practices using the ALCOA framework to ensure data integrity. These initiatives are woven into our procedures and processes because we believe our reputation and integrity hinge on meeting and exceeding all expectations.