R & D Capabilities
- API characterization (physicochemical)- Solubility studies, particle size, polymorphism, bulk properties, hygroscopicity, photostability-study, intrinsic stability studies
- Drug-excipient compatibility studies
- Selection of appropriate packaging material
- Oral Solids
- Immediate release Tablets and capsules
- Modified release Tablets and capsules – Delayed release, Extended release, Targeted release (Colon), Gastroretentive
- Solubility and Bioavailability enhancement
- Bilayer Tablet – Two actives in two layers, One active in two layers with different release profiles
- Fixed Dose Combinations- two or three actives in tablets or capsule dosages
- Clinical Phase –I / II / III formulations
- Paediatric dosage forms - Granules for reconstitution, Dispersible tablet, taste masking
- Mulitparticulate, pellets, minitablets
- Oral Liquids
- Solutions and Suspensions
- Injectables
- Simple Injectables
- Aqueous solution
- Non-Aqueous solution
- Lyophilized injection
- Complex Injectables
- Liposomes
- Nano particles
- Microemulsions
- Suspensions (Aqueous / Non-Aqueous)
- Depot
- Difficult to stabilized lyophilised products
- Peptides / polypeptides / Protein
We follow "Quality by Design" principles in drug product development
- Routine analysis
- API and formulation testing
- Analytical method development
- Analytical method validation
- Stability studies as per ICH
- Formulation Characterization
- Sameness study of suspensions, emulsions, peptide/polypeptide formulations
- In-vitro release / Bioequivalence
- Transfer of technology from R&D scale to pilot / commercial manufacturing scale