Glenmark's clinical research unit in India receives ANVISA approval
Glenmark Pharmaceuticals Ltd has received approval from ANVISA (Agencia Nacional de Vigilancia Sanitaria) for its clinical research unit (CRU) for conducting bioavailability and bioequivalence studies in human volunteers as a part of its regulatory submissions to Brazil.
Located at Turbhe, Navi Mumbai, the Glenmark clinical research unit is spread across 15,000 sq. ft. and provides a fully air-conditioned, comfortable and hygienic housing environment that can accommodate 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 8 beds to conduct Phase I human volunteer studies, claims the company release.
Glenn Saldanha, managing director and CEO, Glenmark, 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."