IPCA Labs' CRO in U.K. adding API space

U.K.-based Onyx Scientific intends to expand is API manufacturing services with the addition of a Class 100,000 suite at its facility in North East England, the CRO announced this week. The announcement is aimed at satisfying an upsurge in Phase I/II GMP campaigns from clients in Europe and the USA. The company said its expansion plans have been approved by the Medicines and Health Products Regulatory Agency in England. Onyx is owned by IPCA Laboratories, the Indian drugmaker which has been having issues with the FDA over manufacturing facilities in India. The FDA last month banned two IPCA formulation plants after last year banning the API facility in India that supplies them after determining employees has been manipulating testing data. Release | More


Suggested Articles

The FDA asked five drugmakers to pull their version of extended-release metformin off U.S. shelves after finding carcinogen contamination.

The FDA backtracked on its earlier testing and found NDMA contamination in the extended release formulation of certain generic versions of metformin.

GSK has formed several collaborations across the globe that will use its AS03 adjuvant to develop vaccines against the novel coronavirus.