Purna provides end-to-end development support for liquid, semi-solid and solid pharmaceutical formulations
From analytical and formulation development through process development, scale-up and clinical manufacturing to commercial production.
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Liquids
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Semi-solids
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Solids
End-to-End Development Process
A structured 6-phase journey from therapeutic concept to compliant batch manufacturing.
Our integrated expertise helps partners efficiently bring products from concept to commercial supply with one experienced partner
Drug Substances & Characterization
Comprehensive analytical support for pharmaceutical development, from compendial testing to specialized characterization of active ingredients.
Type of drug substances: general, corticosteriods, highly potent, controlled drugs
All compendial tests (Ph. Eur, USP, BP…)
Particle size distribution, Residual solvents, Polymorphism, Chirality, Thermal characterization (mDSC)
Analytical Development
Comprehensive analytical support for pharmaceutical development, from method development and validation through stability, microbiology and dissolution testing.
Analytical method development or optimization
Analytical method validation
Finished product specifications
Forced degradation and stability studies
Microbiological evaluation
Dissolution testing
Formulation & Process Development
Comprehensive formulation and process development capabilities for pharmaceutical products, from initial concept through scale-up and commercial readiness.
De novo formulation
Reverse engineering
Re-formulation or creation of new line extensions
Equivalence to reference drug products
Formulating Drug substances with complex chemical or physical characteristics (e.g. low solubility)
Cleaning method development
Upscaling & Technology Transfer
Purna’s extensive experience in pharmaceutical development and manufacturing enables a smooth transition from lab-scale to commercial-scale production. Through robust process development, scale-up and technology transfer, we ensure that formulations and processes are efficiently translated to larger manufacturing scales while maintaining quality, consistency and performance.
Clinical Trial Manufacturing (IMP)
Purna holds a IMP license for production, packing, labelling, analysis and release of clinical trial material providing small scale productions for pre-clinical studies and supply of cGMP clinical material (Phases I-III)
Stability Studies
Purna offers stability storage for all ICH climatic zones supporting long term, intermediate, accelerated, photo-stability, transportation, in-use and ongoing (FUST) stability trials.