Glenmark Pharmaceuticals Clinical Research unit in India receives ANVISA approval

Glenmark Pharmaceuticals Ltd has received Agencia Nacional de Vigilancia Sanitaria (ANVISA) approval for its clinical research unit (CRU) for conducting bio availability and bio equivalence studies in human volunteers as a part of its regulatory submissions to Brazil.

Located at Navi Mumbai, the Glenmark clinical research unit is spread across 15,000sq.ft. and provides a fully air-conditioned housing for around 72 volunteers participating in the clinical studies. Regulatory submissions are also made to the US and the EU from this facility. The CRU has also developed a phase I unit equipped with eight beds to conduct phase I human volunteer studies.

Glenn Saldanha, managing director and CEO, Glenmark Pharmaceuticals, said, "The ANVISA approval helps accelerate the filing of our dossiers in Brazil and is a step towards Glenmark emerging as a strong player in Latin America."