Ranbaxy Laboratories gets US FDA approval to manufacture and market hydrocodone bitartrate, acetaminophen tabs

Ranbaxy Laboratories Limited (RLL) has received approval from the US Food and Drug Administration (FDA) to manufacture and market hydrocodone bitartrate and acetaminophen tablets USP, 7.5 mg/750 mg, 10 mg/500 mg, 5 mg/500 mg, and 10 mg/325 mg strengths and will be launched by November 2007 to all classes of trade.

US FDA has determined the Ranbaxy formulations to be bio-equivalent and have the same therapeutic effect as that norco tablets (10 mg/325 mg) of Watson Pharmaceuticals Inc., vicodin tablets(5 mg/500 mg) and vicodin ES tablets (7.5 mg/750 mg) both of Abbott Laboratories, and lortab tablets (10 mg/500 mg) of UCB Inc.

Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. As per IMS study the total annual market sales for hydrocodone bitartrate and acetaminophen tablets was $390.6 million in June 2007

Recently the company had  has received final approval to manufacture and market Amlodipine Besylate Tablets, 2.5 mg (base), 5 mg (base) and 10 mg (base). US FDA had determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Norvasc Tablets® of Pfizer Pharmaceuticals Inc. Total annual market sales for Norvasc®, Amlodipine Besylate Tablets were $2.79 billion.

The company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.