Neuland Labs Gets Fda Approval For Glaucoma Drug

The Hyderabad-based Neuland Laboratories has successfully undergone inspections carried out by the United States Food and Drug Administration (US FDA) for latanoprost bulk drug.

While Neuland Labs is the contract manufacturer for latanoprost, an anti-glaucoma drug, Drug Master File (DMF) for the bulk drug is filed and owned by an European company. This will enable Neuland Labs to supply latanoprost to the European company, which in turn may launch the generic version of the drug, with the required abbreviated new drug application (ANDA) approval after the expiry of the patent.

Patented by Pharmacia in 1996, latanoprost is marketed under Xalatan brand with an estimated annual sales of $400 million in US. The patent for the drug will expire in 2005.

 

"Though we can supply latanoprost to the European company only after the expiry of the patent, as far as the regulated markets are concerned, we feel that the approval is an achievement in view of the complexity of the drug," said D R Rao, managing director of Neuland Labs.

Earlier, Neuland Labs had also been successfully inspected by the US FDA for salbutamal sulphate as well as rantidine Form-I bulk drug. In addition, one of the Neuland's customers for ciprofloxacin in the US received tentative ANDA approval from the US FDA.

Neuland Labs recorded a net profit of Rs 3.19 crore on a turnover of Rs 76 crore for the nine-month period ended December 2001. It has an equity base of Rs 5.38 crore.