Granules India gets US FDA approval for Acetaminophen
India, April 20 -- Granules India Ltd has announced that 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 consu...
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