ISSAR ’s USFDA compliant R&D, with a state - of - the - art production facility of 62,000 Sft was established at Genome Valley, MN Park, Hyderabad, Telangana, India in 2012.
ISSAR is using the most modern and advanced automatic equipment for the development, synthesis, purification and manufacture of peptide-based drugs. We reached to the level of manufacturing 50 amino acids length of peptides with high quality and purity standards. ISSAR has scaled up the synthetic peptide purity and yield by continued process optimisation. Today we have the capabilities to manufacture 10 Kgs peptide per batch maintaining up to 99.5% purity. ISSAR is able to manufacture and formulate the liquid and lyophilised injectables and topical products.
ISSAR is dedicated towards maintaining the highest standards in the industry. Our Quality Control (QC) group is involved throughout the entire development process, from drug substance and raw material control, through intermediate drug product testing, to finished drug product release testing and stability studies. All Quality Control activities and equipment are fully supported by approved GMP documentation. Our Quality Assurance (QA) group ensures quality management, documentation and records, materials management, laboratory controls, and cGMP. Our QA team also supports any range of validation effort, including process validation, methods validation, and cleaning validations. We ensure our facility operates to full cGMP, and our SOP systems are comprehensive, reaching every aspect of material flow.