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Equateq Facility Certified for GMP Pharma Production in Scotland
26-08-2008: The fatty acid concentration plant run by Equateq in the Western Isles of Scotland has been certified as GMP compliant by Britain’s healthcare authority, giving it the necessary credentials to produce high-end lipid compounds as active pharmaceutical ingredients for the omega oils sector, the company announced.
The facility has been producing pharmaceutical-grade fatty acids since the 1980’s but the formal GMP certification lapsed under previous owners. Equateq officially reopened the facility in September 2007 with the intention of developing it as a global leader in the production and research of high-end fatty acids, and the GMP certification proves that all key manufacturing procedures are now validated and ready for business.
The Medicines and Healthcare products Regulatory Agency (MHRA) found Equateq compliant with Directive 2001/83 EC following an inspection in late July. Inspectors of the facility on the Isle of Lewis ruled that Equateq’s procedures to manufacture active pharmaceutical ingredients for clinical trials were in accordance with the EU legislation governing Good Manufacturing Practice.
‘We have historically operated under GMP procedures, which are part of the DNA of the way we run the plant,’ said Equateq CEO Adam Kelliher. ‘But this latest MHRA certification is crucial for us going forward in our strategy to develop active pharmaceutical ingredients derived from novel means of lipid synthesis.’
According to the company, Equateq uses a combination of fractionation and chromatography to concentrate any fatty acid up to 99% purity. These super-pure compounds can be then used as feedstock for other more advanced methods of lipid synthesis in its dedicated API plant, which has previously undergone an FDA pre-approval inspection. Equateq is already developing novel lipid compounds with the potential to be safe, effective, and side-effect free for various diseases that currently have limited effective treatment.
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