• search
Injectable Formulations Development Services Injectable Formulations Development Services

Injectable Formulations Development Services

Throughout the life cycle of injectable drug product development, we are alongside customers helping them navigate the process and mitigate the risk.

APSL provides end-to-end services in drug product development framework traverse all the way from pre-formulation and formulation development, technology transfer, through GMP clinical trials and commercial production for injectable dosage forms with a focus on quality, speed, and cost-efficiency.

Injectable Drug Product Services

Our services for injectable formulations include performing solubility studies, composition design and optimization, process design and optimization, conducting accelerated and prototype stability studies as per the guidelines, hold time and compatibility studies, reconstitution studies and dilution studies, product container closure system identification, selection and finalization, but not limited to. We also provide services for scale-up activities and manufacturing of clinical batches in a current good manufacturing practice (cGMP) environment. The lifecycle of the drug product is given below



Solubility enhance studies include

  • pH modification
  • Complexation
  • Surfactants or solubilizers
  • Anti-precipitating agents
  • Co-solvency

Formulation Development

  • Literature Survey
  • Qualitative and Quantitative Composition selection and optimization
  • Process selection and optimization
  • Container Closure selection
  • Analytical method development and validation

Stability Studies

  • Prototype Stability studies as per ICH conditions
  • Freeze thaw and Thermal cycling studies
  • Photo-stability studies
  • In-use stability studies
  • Reconstitution and Dilution stability studies

Technology Transfer and GMP Production

  • Method Transfer and master documents preparation
  • Phase I / Phase II / Phase III supplies
  • Commercial supplies
  • CMC regulatory Support

Why Aurigene Pharmaceutical Services?

Services across the product lifecycle

Regulatory inspected lab and manufacturing facilities

Experience in delivering various injectable dosage forms

Expertise in overcoming technical challenges

Virtual Tour


You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.

If you wish to continue to this external website, click Proceed.