IMA: Angina drug API firm JP Laboratories cannot keep Daund plant up to code
The IMA inspectors who visited the plant – Block A-76 known as Unit I - in March identified 28 deficiencies from good manufacturing practices (GMP), including nine major problems in areas like data integrity, materials management and equipment validation.
The agency said: “The extent and severity of the findings, in combination with the repeated negative inspection outcome, demonstrates the inability of the company to sustain an acceptable GMP compliance level, and constitutes a critical risk for public health.”
The IMA recommended that JP should not be allowed to supply APIs and urged national authorities across Europe to conduct assessments products for which the firm supplied the active ingredient should be recalled.
It also said that European Directorate for the Quality of Medicines and Healthcare (EDQM) is in the process of CEPs issued to JP.
JP produces a range of isosorbide APIs at the facility, which are used in treatments for angina and high blood pressure.
JP has been criticised by European regulators before. In 2011, the EDQM withdrew its CEP for Isosorbide mononitrate as a result of breaches of GMP standards. The CEP was reissued in March 2013.
The firm did not respond to a request for comment ahead of publication.
