R&D Facility (India)
ScieGen Pharmaceuticals India Research and Development facility is located in Hyderabad, India. This facility was established to support the filing of Abbreviated New Drug Applications (ANDA’s). The facility consists of over 13,000Sq.ft, and has dedicated labs for formulation and analytical development. The facility was designed to meet local and US FDA requirements and has also obtained all necessary local accreditations. Learn more about ScieGen R&D
Research
R&D: Formulation Research & Development is the core competency of ScieGen Pharmaceuticals. We develop generic formulations with new drug delivery systems, new dosage formulations, and apply new and advanced technology for better processes.
Our R&D facility in Hauppauge, NY covers over 5,000 Sq.ft, and our R&D facility in Hyderabad, India covers over 13,000 Sq.ft, with a multi-disciplinary team of over 50 scientists striving for excellence.
The facilities meet cGMP requirements, and are focused on the areas of analytical research, dosage form development, bio-equivalence studies and technology transfer activities.
We routinely carry out the development of Generic solid oral formulations, novel formulations, and Over-The-Counter (OTC) formulations.
Product development at ScieGen begins with our Product Development strategy. Desired product attributes are identified and prototype formulations are developed to meet those desired attributes. Critical process parameters (CPP) are also identified and process optimization studies are carried out based on Quality by Design (QbD) principles. Based on the formula and process optimization studies, the final composition and manufacturing process is recommended for ANDA batches and Bio – studies.
We routinely carry out the development of Generic solid oral formulations, novel formulations, and Over-The-Counter (OTC) formulations.
