Amino Acid GMP Manufacturing
cGMP-compliant amino acid production with full quality management, regulatory documentation, and analytical capability packages.
Service Overview
SynthAxis operates a dedicated GMP amino acid manufacturing facility meeting ICH Q7 and relevant USP/EP/JP pharmacopoeial standards. Our GMP suites are designed for the synthesis, purification, and packaging of amino acids intended for pharmaceutical, nutraceutical, and clinical nutrition applications.
Our quality management system covers process validation, cleaning validation, equipment qualification, change control, deviation management, and annual product reviews. Every GMP batch is manufactured against approved batch manufacturing records with full traceability to raw material certificates.
We support both small-scale GMP development batches for IND enabling studies and large-scale commercial manufacturing contracts. Technology transfer from our research services team is seamless and well-documented.