Rejection letter of BE studies conducted at the BE centre Synapse Labs Pvt. Ltd. can be downloaded via the links below:
1) Original version: Penolakan Kajian Bioekuivalens (BE) yang Dijalankan oleh Pusat Kajian BE Synapse Labs Pvt. Ltd. Susulan Penemuan Pemeriksaan European Medicines Agency (EMA)
2) Translated version: Rejection of BE Studies Conducted at the BE Centre Synapse Labs Pvt. Ltd., India following Inspection Findings by The European Medicines Agency (EMA)
Thank you.