Zydus Receives US Approval for Schizophrenia Generic Medicine

Zydus Lifesciences Ltd announced that it has been granted final approval by the FDA to produce paliperidone extended-release tablets in doses of 1.5 mg, 3 mg, 6 mg, and 9 mg. Paliperidone extended-release tablets are prescribed for treating schizophrenia in both the acute and maintenance stages, as well as for treating schizoaffective disorder either alone or in combination with mood stabilizers and/or antidepressants.

Paliperidone extended-release tablets are going to be manufactured at the company's production facility in SEZ, Ahmedabad. Based on IQVIA MAT July 2024 data, the United States saw annual sales of paliperidone extended-release tablets totaling $47.1.

The leading pharmaceutical firm announced that it had received an Establishment Inspection Report (EIR) from the US FDA after an inspection in July 2024.

Zydus Lifesciences’ transdermal patch manufacturing facility in Pharmez, Ahmedabad was inspected by the US health regulator from July 15-19, according to the company's exchange filing. The USFDA has issued an EIR for the facility, categorizing it as 'voluntary action indicated' (VAI) status.

In August, Zydus Lifesciences' drug manufacturing facility in Jarod, Gujarat received a warning letter from the FDA after an inspection in April 2024. The examination brought attention to insufficient Current Good Manufacturing Practices (CGMP), specifically concerning cross-contamination, particulate contamination, and inadequate aseptic procedures.