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.
Service Offerings:
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 Injectable Formulations 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
Hyderabad R and D Center
Bangalore R and D Center
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
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