Midatech secures manufacturing certification from Spanish regulatory authority

The company received formal notification from AEMPS for an extension to its licence 6458E: Manufacturer of Investigational Medicinal Products, to include the manufacture of monodispersed controlled release microcapsules, marking the completion of the rigorous upscaling process conducted between November 2016 and September 2017.

This licence amendment is required for the use of Midatech's Sustained Release products manufactured at its Bilbao facility, including octreotide (MTD201) which is shortly due to commence clinical trials.

This license adds to the current Bilbao approvals including ES/0241/11: Certification of GMP Compliance of a Manufacturer; 11441/2011/FAB: Authorisation for the Manufacture of Gold Nanoparticles; and Authorisation 6458E: Manufacturer of Investigational Medicinal Products – Specifically Nanoparticles for Use as Carriers for Active Pharmaceutical Ingredients.

Commenting on the manufacturing update, Dr Jim Phillips, Chief Executive Officer of Midatech Pharma, said: "The manufacturing facility in Bilbao continues to develop as a centre of excellence, currently producing all our human clinical stage products. This latest certification allowing GMP for our Q-Sphera products such as Q-Octreotide, allows us to continue our key programmes and to start preparing for commercial scale manufacture as our products get closer to filings with the FDA and other agencies."