Comm Issue No.PEM01-CEM01-2025 – Bioequivalence studies performed by Contract Research Organisation (Synapse Labs Pvt. Ltd)

This document is intended to communicate the South African Health Products Regulatory Authority’s (SAHPRA’s) position to all applicants/Holders of Certificates of Registration (HCRs) who intend to submit/have submitted applications supported by bioequivalence studies conducted by Synapse Labs Pvt. Ltd, a Contract Research Organisation (CRO) located in Pune, India, and SAHPRA’s intention to request information in terms of Section 19(2) of the Medicines and Related Substances Act, Act 101 of 1965, as amended (The Medicines Act).