Glenmark Pharmaceuticals Clinical Research unit in India receives ANVISA approval

08 Feb 2006

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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."

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