Your Partner in Pharmaceutical Excellence
Learn more about our gmp chemical development & manufacturing services and capabilities.
We at Shilpa Medicare Limited have 30years of cumulative experience process development, scale up, and cGMP (Current Good Manufacturing Practice standards, as defined by the FDA). Now as a CDM Organization we are ready to develop/synthesis/manufacture wide range of products with all cGMP compliance.
Shilpa Medicare Limited process comply all GMP regulation as required by FDA. We assure the quality and purity of our products. Our Quality control departments continuously monitor production.
Laboratory to kilo lab to pilot to commercial, with process safety assessment and thermal hazard evaluation at each stage.
Process validation protocols and execution, and continued process verification.
Drug Master File authoring and filing, CEP and ASMF submissions, agency query response, and change control support.
Long-term supply agreements, capacity reservation, second-source qualification, and supply security planning.
GMP chemical development and manufacturing is carried out at Shilpa Medicare's Raichur, Karnataka facilities, part of a small-molecule CDMO platform spanning approximately 1,160 KL of reactor capacity across 21 blocks, including nine dedicated high-containment blocks engineered to OEL-4.
