Syntagon has successfully renewed its GMP certification for the manufacture of clinical APIs following an audit by the Swedish Medical Products Agency. The two-day audit scrutinized Syntagon’s facilities, documentation, QA and QC departments.
The Swedish agency, known as Läkemedelsverket, carries out GMP audits every three years. Syntagon first gained accreditation from the Agency in 2003. The certification allows Syntagon to continue to make clinical APIs for clinical trials throughout Europe and North America.
“We are delighted to be successfully re-audited by the [Swedish Medical Products] Agency. It demonstrates our continued commitment to quality and our full compliance with GMP,” said Paul Alhadeff, Syntagon's QA officer.
With operations in Sweden, Latvia, and China, Syntagon specializes in synthetic preparation of small molecules under GMP manufacture.
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