USFDA nods for Granules India's generic pain reliever

Granules India Ltd Thursday announced that the US Food and Drug Administration approved its Abbreviated New Drug Application (ANDA) for Acetaminophen 650 mg Tablets, Extended Release, a generic version of Tylenol 650mg tablets, Extended Release.

Acetaminophen 650 mg extended release tablets are used primarily for temporary pain management including arthritis relief, a press release from the city-based drug maker said.

"The addition of Acetaminophen 650mg, extended release tablets to our OTC ( Over the Counter) portfolio leverages several components of our value proposition," Krishna Prasad Chigurupati, Chairman and Managing Director of Granules India said.

Granules India is the only supplier that is equipped with backward integration up to the Active Pharmaceutical Ingredient of this product, he added.

"With a capacity of over 24,000 tonnes per annum Acetaminophen API and finished dosage capacity of more than 18 billion units/year, we are confident that we will ensure supply security to our customers which will support us to capture our target market share," Chigurupati said.