Novugen develops, manufactures and distributes pharmaceutical generics that have a proven efficacy and are the latest in the line of treatment. We specialize in complex, niche and technology-intensive products that meet strict global quality standards.

We are proud to be the first Malaysian company to have filed API DMF and the first to file an ANDA for US product registration, setting a new standard for the Malaysian pharmaceutical industry. Novugen is also the only company in the ASEAN region involved in Para IV and NCE-1 filings in the US.

Capabilities to develop and manufacture wide dosage forms.
  • Tablets, capsules and powders
  • Liquids, solutions, suspensions and emulsions
  • Lyophilized powders for injection
  • Granules for reconstitution
  • Drug in capsule/vial
  • Drug in capsule/vial
  • Other novel dosage forms, including MUPS, OCAS and DDR
Quality & Efficacy

At Novugen, quality and efficacy are the foundations of our product strategy and we are committed to ensuring strict adherence to the highest of standards.

Quality

We are regularly inspected to ensure that our quality management system is complete throughout; and our own internal audit processes mean that we maintain and develop our systems in line with the latest global legislation and guidelines. By meeting the strict requirements of the USFDA, PIC/S and WHO, we are positioned to export products world-over.

Our regulations and compliance systems assure pre-qualification of material vendors. We operate with stringent in-process system that provide controls over any changes and documentation.

All equipment, installations, products, processes and cleaning operations are completely validated and documented.

At every phase of the production, our teams work with the most advanced analytical and quality control instruments.

Efficacy

Our research and development teams specialize in creating alternate and patentable processes for bioequivalent generic formulations. Our analytical lab carries out analytical method validation (AMV) to ensure we meet efficacy, consistency and stability standards that are acceptable to all global regulatory agencies.