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RPI-Core Pharma joint venture gets US FDA approval for acetaminophen extended-release tablets
Our Bureau, New Delhi | Monday, April 1, 2002, 08:00 Hrs  [IST]

Ranbaxy Pharmaceuticals Inc. (RPI) and Ohm Laboratories Inc., both wholly owned subsidiaries of Ranbaxy Laboratories Limited, India, in a collaborative and exclusive venture with Core Pharma LLC, announced today receiving the FDA approval for acetaminophen extended-release tablets, 650mg. In this co-development and participative arrangement, Core Pharma LLC of Middlesex, New Jersey, retains ownership for the ANDA and will manufacture the product, while Ohm Laboratories will have exclusive commercial rights to market this OTC product.

RPI/Ohm's acetaminophen arthritis tablets has an AB rating with proven bio-equivalence to Tylenol arthritis pain extended relief caplets. It is indicated for the temporary relief of minor aches and pains caused by arthritis, common cold, headaches, toothaches, muscular aches, backaches and menstrual cramps.

Tylenol arthritis pain extended relief caplets is a registered trademark of McNeil Consumer Healthcare

The annual sales for acetaminophen arthritis tablets is around $ 50 million (IRI, 52nd week end 9-09-01). RPI/Ohm is the second generic manufacturer to be approved to market this product but the generic demand is largely unfulfilled because of manufacturing difficulties.

Ohm Laboratories Inc. plans to launch this product in May 2002. This addition to Ohm's broad product portfolio enhances the company's new product momentum in the growing OTC market which has a broad therapeutic representation in the analgesic, gastrointestinal and cough and cold categories.

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