Process Development and Optimization based on QbD Principles
Elixir Pharma
Elixir Pharma is one of the leading research driven manufacturing facility having focus towards the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and Drug intermediates of generic APIs for Regulated and Semi regulated markets.
Our R&D team focuses on process development and optimization, using advanced analytics and modeling tools to speed up the development and scale-up of new products. We employ a data-driven approach to identify and mitigate risks, ensuring that our products meet and exceed regulatory requirements and industry standards.
At Elixir pharma, we are committing to innovate and continuously improve. Our R&D is advancing the science of pharmaceuticals and developing new and innovative products that meet the needs of our clients worldwide.
The R&D team of Elixir is having highly experienced, skilled professional scientists comprising doctorates, post graduates and graduates specializing in process & analytical development for the manufacturing APIs and drug intermediates, which enables high efficiency and excellent quality.
The state of art analytical research laboratory mirrors that of the Quality Control and is having equipment which consists of HPLCs, UHPLCs, GCs, GC-HS, GC-HSMS, XRD, FT-IR, Karl fisher, Auto-titrator etc.for regular analysis, method development, stability studies and analytical method validation.
There are Kilo & Pilot Labs which are fully equip with 10L – 200L Glass assemblies for feasibility trials. Our Kilo and Pilot plant are operating in cGMP condition and are capable to scale up process and filing processes developed in the synthetic lab.
Process Development and Optimization based on QbD Principles
Development of Analytical Methods
Impurity Synthesis, Isolation and Characterization
Process Scale-up and Technology Transfer
Evalution of Genotoxicity and Nitorosamine Impurities