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Our Bureau

The studies involve tests on 50-100 human volunteers to evaluate the safety profile and safe dosage range of the drug.

Mumbai , Feb. 8

GLENMARK Pharmaceuticals Ltd has got regulatory approval from the Brazilian authorities to conduct bioavailability and bioequivalence studies in human volunteers.

The company has got clearance from ANVISA (Agência Nacional de Vigilância Sanitária) for its clinical research unit for studies to be done on human volunteers, a company statement said.

The clinical research unit is located at Turbhe, Navi Mumbai and can accommodate about 72 volunteers. It also has developed a phase I unit equipped with eight beds to conduct phase I human volunteer studies. These studies involve tests on 50-100 human volunteers to evaluate the safety profile and safe dosage range of the drug. Regulatory submissions have also been made to the US and the European Union from this facility, the note added.

Mr Glenn Saldanha, Managing Director and Chief Executive Officer, of the company said the Brazilian approval

would help accelerate the filing of dossiers in Brazil and help the company strengthen its position in the Latin American market.

In March 2003, Glenmark set up a wholly-owned subsidiary, Glenmark Farmacêutica Ltda, in Brazil. Subsequently, it acquired a private Brazilian firm, Laboratorios Klinger in April 2004. GFL markets a portfolio of 24 products in Brazil, including Klinger's original product basket, three products registered recently and a leading contraceptive brand Uno-Ciclo, acquired recently from Instituto Biochimico Indústria Farmacêutica Ltda, the note said.

Glenmark shares closed on the BSE at Rs 325.1, up 0.26 per cent.

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