Ranbaxy gets FDA approval

NEW DELHI, MAR 21: Ranbaxy Pharmaceuticals Inc has obtained approval from US authorities to market its new analgesic formulation Pentazoc...

NEW DELHI, MAR 21: Ranbaxy Pharmaceuticals Inc has obtained approval from US authorities to market its new analgesic formulation Pentazocine 50mg, Naloxone 0.5mg8217;.

Ranbaxy has obtained Abbreviated New Drug Application ANDA approval from the US Food and Drug Administration FDA to market the drugs, the company said in a statement here today.

Company sources said that Ranbaxy targets a business of 5 million in the US market in the first year itself. The formulation, developed by Ranbaxy8217;s wholly-owned subsidiary Ohm Laboratories, would be marketed in the US by Ranbaxy Pharmaceuticals Inc, the sources said.

Sanofi Cynthelabo, the only other company that markets a similar kind of drug under the name Talwin NX8217; in the US market, has a turnover of 50 million, they said.

Ranbaxy, the first Indian company to receive an approval in the quot;potent analgesicquot; segment, has filed 26 ANDAs in the US and has received a total 16 approval for eight molecules, the statement said.

The new formulation, which would be used for post-surgeries and acute pains associated with ailments like cancer, is presently the only generic approved in the US for this kind of product, the company said.

Ranbaxy which has an expanding international portfolio of affliates, joint ventures and alliances, has operations in over 24 countries and manufacturing operations in six countries.

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The company which spent Rs 53.8 crore last calender year for Ramp;D has so far received FDA approvals for 16 drugs including Cefaclor, Ranitidine, Acyclovir, Amoxicillin and Cephalexin in the US.

Ranbaxy earned Rs 43.5 crore through technology licencing income for the calender year 1999. The company8217;s total sales were at Rs 1,558.20 crore in the calender year 1999, with domestic sales at Rs 823.7 crore while exports at around Rs 734.5 crore. Rambaxy posted a net profit of Rs 201.2 crore during the same period.