Formulation Development
Progenerics Pharma is focused on developing high quality affordable generic products for global markets. Our teams are equipped with full fledged laboratories and aim to develop new forms with high added value and niche generic products.
We work to perform R&D activities in compliance with all ethical and legal principles in a manner to meet the expectations of the concerned authorities; prove that the safety, efficacy and quality of the products do not change throughout the shelf life, increase product accessibility, develop sustainable methods to increase efficiency.
The operating principle requires product quality meeting current standards, and finding new formulations, new dosage forms, and different routes of synthesis and/or new polymorph methods that do not infringe patents for raw materials.
Our long-term goal is to become a pioneer in developing generic drugs, create a difference by developing products with added value, to continue to develop products for regulated markets, invest in our future by adapting new technologies to our company, develop products with high value by means of cooperation between universities and the industry, and ensure protection of our rights by patent registration.
Progenerics Pharma contains Pre-Formulation Area and Pilot Manufacturing plant, Scale-up Laboratories, Stability Area, Analytical Development Laboratories, Pilot Manufacture Area, Raw Materials, Packaging Materials and Finished Products Storage Areas, and Documentation archives, covering a total area of 21000 sq.ft.
Our Teams and Facilities are capable of developing all dosage forms like General Solids and injectables, Oncology Solids and Injectables including Lyophilized products, Creams & Ointments, Hormones and Ophthalmics. Also first to file opportunities and Complex generics.
- Initial formulation design and screening leading to lead prototype (composition and processes) identification
- Choosing suitable manufacturing process
- Scale-up of prototype
- Process parameters optimization for manufacturing process using QbD approaches
- Manufacturing of batches for stress stability (ICH conditions)
- Scale-up of batches and technology transfer