Nerudia gets MHRA license

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Nerudia gets MHRA license

July 22, 2016

Nerudia has been licensed by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture pharmaceuticals at its Liverpool facility for both clinical trials and commercial drug products.

To qualify for the license, Nerudia has shown the MHRA that its infrastructure, processes and policies comply with EU Good Manufacturing Practice (GMP). The company also had to pass an inspection of its facility, which houses 15 Grade D cleanrooms.

The rigorous three-day inspection covered the manufacture, source and supply of both investigational medicinal products for clinical trials, and a manufacturer’s license for pharmaceuticals that are already licensed.

“We are delighted to have received this license from the MHRA, which represents the culmination of a significant amount of hard work,” said Mark Dignum, Nerudia chief operations officer.

“This enables us to work with clients and other partners to develop, license, and commercialize pharmaceutical products from concept to the pharmacy shelf. This also provides an excellent foundation for FDA approval”.

“This endorsement from the MHRA gives assurance to customers buying non-pharmaceutical products, such as e-liquid, that Nerudia provides high-quality products that are produced consistently; essential for compliance in a regulated environment,” said Andy Gaunt, Nerudia’s chief commercial officer.

“As a company dealing with global customers the license underpins our complete business offering, from innovation and regulatory compliance to product manufacturing. Whether our clients want to comply with TPD, FDA deeming regulations, or market a medically approved product, we have the capabilities in place to deliver this”.

Category: Breaking News

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