License for e-liquid manufacturer
The e-liquid manufacturer Nerudia said today that it had been licensed by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture pharmaceuticals at its facility at Liverpool, UK, for both clinical trials and commercial drug products.
In making the announcement, the company, which ‘offers the development, manufacture, testing and regulatory compliance of nicotine products for the e-cigarette and pharmaceutical markets’, said it had always regarded quality and consistency as paramount, and that the awarding of the license ‘gave further assurance to customers in an increasingly regulated environment’.
‘To qualify for the licence, Nerudia has shown the MHRA that their infrastructure, processes and policies comply with EU Good Manufacturing Practice (GMP), and passed an inspection of their facility which houses 15 Grade D cleanrooms,’ the company said in a press note. ‘The rigorous 3-day inspection covered the manufacture, source and supply of both IMPs (Investigational Medicinal Products) for clinical trials, and a manufacturer’s licence for pharmaceuticals which are already licensed.’
Mark Dignum, Nerudia’s COO said the company was delighted to have received the license from the MHRA, which represented the culmination of a significant amount of hard work. “This enables us to work with clients and other partners to develop, license, and commercialise pharmaceutical products from concept to the pharmacy shelf,” he was quoted as saying. “This also provides an excellent foundation for FDA approval.”
Meanwhile, Andy Gaunt, chief commercial officer, said the MHRA endorsement gave assurance to customers buying non-pharmaceutical products, such as e-liquids, that Nerudia provided high-quality products that were produced consistently, which was essential for compliance in a regulated environment. For a company dealing with global customers, the license underpinned its 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,” he said.
