25,03.2024 - CHMP opinion (re-examination)

On 21 March 2024, EMA’s human medicines committee (CHMP) confirmed its recommendation to suspend or not grant the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd., a contract research organisation (CRO) located in Pune, India. This confirmation concludes the re examination requested by the applicants and marketing authorisation holders for some of the medicines concerned.

15.12.2023 - CHMP opinion

EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd, a contract research organisation (CRO) located in Pune, India.

21.07.2023 Start of procedure

The European Medicines Agency (EMA) has started a review of medicines for which studies have been conducted by Synapse Labs Pvt. Ltd., India.

Further information

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