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
Pre-formulation
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
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Hyderabad R and D Center
Bangalore R and D Center
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