Infrastructure & Equipment of Formulation Development
We develop a robust and cost-effective manufacturing process for smooth scale-up or commercialisation. Our selection of ingredients and process ensures production of cost effective quality products.
Our Process Development (PD) strategy provides a promising process for converting a drug from discovery laboratories into an efficient drug delivery system. We develop manufacturing processes for very low percentage of APIs in tablets and capsules. In addition, our experience involves improvement of flow properties of low bulk density material that yields trouble free product on the shop floor. Our scientists are well-versed in developing processes for complex formulations and innovative technologies such as enteric-coated capsules, nano-suspensions, multi-layered pellets and micro-tablets.
Our scientific team is experienced in scaling up from R&D batches to commercial batches. In addition, our expertise includes scaling batch sizes up to 1,000 kilograms in state-of-the-art facilities. Our team is experienced in execution of process validation batches as per world-wide regulatory requirements.
GVK BIO is flexible in accommodating its valuable scientific resources and facilities to serve its customers through short term projects that are highly specific but critical for new product registrations or upgradations of existing products. We call this segment of our services as Customised Formulation Research Projects as we arrive at project scope only after thorough discussions with the customers.
Also, we present our approach to the customer and classify into any of the following but not restricted to:
We reformulate with better understanding of retrospective data by application of scientific excellence and past knowledge. Our scientists are capable of proposing competent strategies and effectively implement them to resolve the challenges in formulations development for different business partners. We consider the evolving regulatory guidelines including SUPAC/similar ones while reformulating the product.