Formulation Research

Omgene’s endeavor to create generic formulations is inspired by the philosophy of bringing good health to many by offering high quality affordable generic versions of expensive innovator medicines. Omgene’s commitment is dominant for bringing quality and innovation in its pharmaceutical products.

Omgene’s formulation and research is an amalgam of proficient and experienced scientists, technicians and chemists works relentlessly to solve tough challenges and provide innovative solutions for patients. To benefit patients and deliver intellectual property to the organization, Omgene continually strives to discover engineering solution of drug therapies to improve safety and efficacy.

Currently, Omgene is working on novel formulation strategies  which may lead to more patient compliance and increase the efficacy and safety profile of drug.

Activities

  • Design of Product Strategy
  • Patent Landscaping including Proof of Concept and Patent filing
  • Drug Substance Characterization as part of Pre-formulation and Identification of Critical Material Attributes
  • Excipient selection with identified and justified Critical Material Attributes
  • Formulation Development by DoE (Design of Experiments)
  • Formulation and process optimization;
  • Process development and scale-up from lab to manufacturing scale.
  • Packaging Development and Stability Studies
  • Risk assessment, Risk Mitigation and Control strategy are our strengths in Technology Transfer.
  • Product Dossier Compilation for regulatory submission.