Our Formulation &
Development Facility is well-equipped for development of various solid dosage forms
along with capability to handle semi-solid and liquid dosage forms.
We have a specialized team which spearheads our research in for the development of market-specific products. Our development scientists possess substantial experience and expertise in the area of formulation & development and transfer of technology of developed products. Our key focus areas are Modified Release Formulations as well as Immediate Release Formulations of poorly bio-available products.
We have used proprietary hydrogel matrices, as well as non-polymeric release rate controllers for Modified Release Products, and absorption enhancement processes for molecules with poor bio-availability. Our formulation development team undertakes work on new active substances, generics and reformulation of existing products. Our facility works in following areas; pre-formulation, formulation of wide variety of dosage forms, and technology transfer of developed products.
Robust analytical method is a major milestone in quality product development and for faster regulatory approval. Team of analytical experts designs analytical methods which are best suitable for intended use of application. The team has expertise in developing stability indicating analytical methods using Quality by Design approach and as per current regulatory requirements. We believe in developing methods those are'right at the first time'.
Forced degradation studyis 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 process.
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.