Syntagon successfully renews GMP accreditation

16-Jul-2009

Specialist contract research organisation, Syntagon, has successfully renewed its Good Manufacturing Practices (GMP) certification for themanufacture of clinical active pharmaceutical ingredients (APIs) following an audit by the Swedish Medical Products Agency.

Specialist contract research organisation, Syntagon, has successfully renewed its Good Manufacturing Practices (GMP) certification for themanufacture of clinical active pharmaceutical ingredients (APIs) following an audit by the Swedish Medical Products Agency.

GMP compliance is an international requirement for the manufacture of medicinal

products for human and veterinary use and helps maintain the quality and safety

of medicinal products.

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,. says Paul Alhadeff, Syntagon Quality Assurance

Officer.

The two-day audit scrutinised Syntagon's facilities, documentation, Quality

Control (QC) and Quality Assurance (QA) departments.

The Agency, known as Laekemedelsverket in Sweden, 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.

With operations in Sweden, Latvia, and China, Syntagon specialises in synthetic

preparation of small molecules under GMP manufacture.

Syntagon's expertise in GMP manufacture, as well as analytical chemistry and

crystallisation is tailored for all client types: from single-product start-ups, to

global pharmaceutical groups.

Syntagon is a leading Scandinavia-based drug development partner. We develop

compounds from lead optimisation to phase II clinical trials using the latest

technology and equipment combined with a solid quality system.

For further details on this press release, please contact John Cameron, Syntagon

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Director of Sales & Marketing Europe at john.cameron@syntagon.se.

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