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Glossary

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Current Good Manufacturing Practice (cGMP)

What is cGMP in Pharmaceutical Manufacturing? cGMP, or current Good Manufacturing Practice, refers to regulations enforced by the U.S. FDA to ensure drug products are consistently produced and controlled to meet quality standards. These regulations are codified in 21 CFR Part 210 (manufacturing, processing, packing, holding of drugs) and Part 211 (finished pharmaceuticals). These rules establish the methods, facilities, and controls essential for […]

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Custom Synthesis

What is Custom Synthesis? Custom synthesis is the bespoke creation of specific chemical compounds—like APIs, intermediates, reference standards, or fine chemicals—tailored to a client’s exact requirements in terms of structure, purity, quantity, and documentation. It’s typically performed under confidentiality agreements. Why is Custom Synthesis Vital in Pharma? Custom synthesis supports drug discovery and development by enabling rapid

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