MicroPharm’s Cilgerran Manufacturing Site licensed by the MHRA
MicroPharm Limited is pleased to announce that its new manufacturing site at Cilgerran, North Pembrokeshire, UK has now been granted a Manufacturing / Importers Authorisation (MIA) licence, MIA Investigational Medicinal Products (IMP) licence and a “Specials” licence by the Medicines & Healthcare products Regulatory Agency (MHRA), UK. The site is in production and is initially being used for the manufacture of Viperfav™ and Bothrofav™.
The manufacturing site comprises 473 m2 of Class C and Class D cleanrooms, walk in fridges, Quality Control and development laboratories, a warehouse and offices. From initial design, the project has taken 5 years and included the transfer of the manufacturing technology and products from Sanofi Pasteur.
CEO, Ian Cameron, commented: “The successful conclusion to this project is the result of the expertise, professionalism and hard work of the staff. MicroPharm now has the infrastructure in place to facilitate further growth. We will retain our existing manufacturing site at Newcastle Emlyn where we will manufacture EchiTAbG, Fav-Afrique and Favirept and where all products are filled. The Cilgerran project has been made possible by the significant investment by MicroPharm’s majority shareholder, Flynn Pharma (Holdings) Limited.” David Fakes (CEO & Chairman) added: “We are delighted to reach this milestone and thank all our colleagues who made this possible. MicroPharm is now uniquely positioned to make an important contribution to the treatment of snakebite envenomation in Sub-Saharan Africa, the Middle East and North Africa”.
MicroPharm is a major employer in West Wales and is the leading manufacturer of antivenom for the European market.
Posted on: Monday, 11th March 2024