Research and Development
R & D facility located at Chinchwad near Pune is best in class and approved by DSIR, R & D has developed over 325 formulations in-house of which more than 120 products ranging from Dry Powder Inhalers to Nasal Sprays and Bi-layered tablets to Ointments and Creams are manufactured at Sava’s own manufacturing facility at Surendranagar & commercialized for markets like Canada, Ukraine and the CIS, Asia, Africa & FWA.
Formulation Development
- Specialized formulations Dry Powdered Inhalers and Nasal Sprays
- Formulation troubleshooting and Process Development of existing dosage forms
- Development and Optimization of existing formulations
- Tablets [Uncoated/Film Coated/Enteric coated/Sugar coated/Effervescent]
- Capsules [Starting from Size 0 to Size 4 Caps
- Ointments [Ointment/Cream/Gel]
- Excipient compatibility
- Quantitative and Qualitative evaluation of proprietary dosage forms
- Infrastructure Support
- Separate Dedicated Area for Raw Material under Lock and key
- Separate AHU system in each area of Formulation and Development
- Under development plan for new Dedicated Facility of Aerosol/MDI products
Analytical Development
Analytical development is a vital component of our R&D agenda with special focus given to:
- Analytical Method Development for Assay, Dissolution and Related Substances
- Testing of API and Excipients as per Pharmacopeia and by In House Method
- Method Validation – for Assay, Dissolution and Related Substances
- Stability Studies as per ICH Guidelines
- Process Validation and Packing Validation
- Comparative Study with Innovator for various parameters as per Pharmacopeia and by In House Method
- Dissolution Testing
- Documentation for audit trail
DUSA Apparatus (Copley Scientific, UK)
Next Generation Impactor (Copley Scientific,UK)
It is used for the determination of Aerodynamic particle size distribution (APSD) and fine particle fraction (FPF) of Dry powder inhaler formulation (DPI) and Metered dose Inhalation (MDI) products. This test gives us the idea about the amount of dose reaching to the lungs.
Spraytec (Malvern, UK)
It is used for the determination of droplet size distribution (DSD) by laser diffraction technique i.e. D10, D50 and D90 of Nasal spray and Metered dose inhaler (MDI) products. For nasal sprays, droplets with size less than 120 µm will reach to the site of action (nasal cavity).
Spray View (Proveris Scientific, USA)
It is used for the determination of Spray pattern (Spray area and Ovality ratio) and Plume geometry (Plume angle and Plume width) of Nasal spray products and MDI products. The Spray pattern and Plume geometry gives us the idea about size, shape and angle of the spray which determines the efficacy of the products.
Regulatory Affairs
In today’s competitive environment the reduction of time taken to reach the market is critical for product and company’s success.
Our Regulatory Affairs team keeps track of the ever-changing legislation in all the regions in which the company intends to market its products.
Our Regulatory Affairs is capable of all types of regulatory submissions (Dossiers / ANDA / ANDS / CTD / e CTD) for any of the semi-regulated to highly regulated markets ensuring fast turnaround in business.
Registration Letter
