Hyderabad: Granules said the US FDA has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen 650 mg tablets, extended release, bioequivalent to the reference listed drug product (RLD), Tylenol 650mg tablets extended release.
Acetaminophen 650 mg extended release tablets are used primarily for temporary pain management including arthritis relief
“The addition of Acetaminophen 650mg, extended release tablets to our OTC portfolio leverages several components of our value proposition. Granules’ is the only supplier that is backward integrated up to the API on this product. Our vertically integrated approach will enable us to provide a high-quality, cost-efficient product that benefit consumers. With a capacity of over 24,000 mt/year of 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,” said Krishna Prasad Chigurupati, chairman & managing director of Granules India.