14.10.2020 - Notice within the graduated plan procedure (“Stufenplanverfahren”)

The German Federal Institute for Drugs and Medical Devices (BfArM) has provisionally ordered the suspension of the above-mentioned generic drug approvals in its decision of October 7, 2020.

24.07.2020 - Suspension of approval

EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of generic medicines tested by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai, India.

The recommendation comes after Austrian and German inspectors found irregularities in how the company carried out bioequivalence studies. These are studies used to show that a generic medicine produces the same amount of active substance in the body as the reference medicine.

28.02.2020 - Procedure started

The European Medicines Agency (EMA) has started a review of medicines for which studies have been conducted by Panexcell Clinical Laboratories Priv. Ltd. at its site in Mumbai, India. This follows a good clinical practice (GCP) inspection which raised concerns about the study data used to support marketing authorisation applications of some medicines in the EU. The inspection was carried out jointly by Austrian and German authorities in October 2019 in the context of the evaluation of an application for marketing authorisation of a medicine.

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Panexcell