A trusted supplier of Active Pharmaceutical Ingredients for phase I/II clinical trials.
Seamless integration of process optimization, (non-GMP) validation, and GMP-manufacturing. A modern facility run by an experienced team with a high standard quality management system.
As part of MercachemSyncom, we offer GMP manufacturing of drug substance for clinical trials (phase I/II) up to the multi-kilogram scale. Our experienced team has a long track record in the production of small-molecule active pharmaceutical ingredients (APIs), as well as drug-linker conjugates for antibody–drug conjugate (ADC) products. All these activities are based on ICH QA7 quality management guideline.
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Material for Clinical Trials
Phase I/II clinical batch following ICH QA7 quality management guidelines.