Research and Development
Kusum’s Research & Development Facility is equipped with world-class infrastructure and industry leading manpower, developing various solid dosage forms along with the capability to handle semi-solid and liquid dosage forms.
We have a specialized team which spearheads research in the development of market-specific products. Our development team possess substantial experience and expertise in the area of formulation & development and transfer of technology of developed products. Our key focus areas are Immediate Release, Modified Release & Sustained Release Formulations.
Our formulation development team undertakes work on new active substances, generics and further improving effectiveness of existing products.
All formulations are developed in-house at the state-of-art formulation R&D centre, recognized by the Ministry of Science and Technology, Government of India. The company currently has over 100 dossiers available with a strong regulatory team to provide dossiers in CTD and ACTD formats to commercialize new formulations.
Our team of R&D experts have designed analytical methods which are best suitable for the intended use based on the desired application. The team has expertise in developing stability indicating analytical methods using Quality by Design approach strictly adhering to the current regulatory requirements.
Formulation Development Services
Forced Degradation Study
Forced degradation study is integral part of analytical method, in order to establish stability indicating behaviour of methods and product characteristics.
Method validations are carried out as per ICH and latest regulatory norms and in accordance to GLP requirements. Good documentation practices are followed throughout the processes.
Analytical methods are transferred to receiving unit through a protocol bound study in accordance with regulatory requirements.
To enhance the quality of product at R&D, scale stability studies are conducted as per ICH norms.
Analytical Development facility is well-equipped with state-of-the-art modern sophisticated instruments, equipment and software (UPLC, HPLC, GC, UV, different types of Dissolution apparatus, Osmometer, Diffusion cell apparatus etc.) with an expert team of highly qualified professionals.