Bristol Laboratories is back in business in the U.K.
The U.K. generic drug maker, whose partial suspension by European regulators in 2017 led to shortages of some drugs, has passed its latest Medicines and Healthcare products Regulatory Agency (MHRA) inspection.
Bristol Director of Quality and Regulatory Affairs Priti Ramachandran said the company “welcomes the full reinstatement of GMP status for our UK manufacturing facilities, following successful MHRA inspections," Manufacturing Chemist reports.
The suspension over quality and data issues was imposed two years ago following an inspection of the company’s facility in Luton. It resulted in the company producing only products considered medically critical to EU members. It was extended in 2018 when follow-up inspections found ongoing issues.
Ramachandran said the status change would allow Bristol to focus on maintaining supplies when Brexit is complete. Drugmakers have been required to build up their supplies in the U.K. of critical drugs to try to avoid shortages if Brexit results in delays delivering medicines from manufacturing facilities outside the country.