Caplin Point Labs gets USFDA nod for anticholinergic drug

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Pharmaceutical manufacturer Caplin Point Laboratories Ltd said it received approval from the US Food and Drug Administration for sales of a generic equivalent of West-Ward Pharmaceuticals’ Robinul drug.

Glycopyrrolate is a synthetic anticholinergic medication which works by blocking acetylcholine activity on smooth muscles and other tissues. Acetylcholine is a neurotransmitter, or a chemical that nerves use for transmitting.

Blocking of acetylcholine leads to a reduction in the volume and acidity of stomach secretions and a decline in pharyngeal, tracheal and bronchial secretions. Glycopyrrolate also reverses symptoms of excessive bronchial secretions, bronchospasm, low heart rate and hypermobility.

Glycopyrrolate injection had an annual sales of around $110 million in the US market in doses ranging from 1 ml to 20 ml.

With this, Caplin has so far received 4 approvals – three in partnerships and one under its own name and filed 11 applications for sales of generic drugs.

Headquartered in Chennai, Caplin Point Laboratories caters predominantly to the Latin American and African markets. The company has received over 2,800 product approvals.

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