The product manufactured by Granules is a bioequivalent to the reference listed drug, Tylenol extended release 650 tablets.
Priyanka Chigurupati, executive director of Granules USA, Inc. & Granules Pharmaceuticals, Inc. said, “We received the approval within eight months of filing. This is a step towards global expansion of our core molecules.
The approval of acetaminophen extended-release tablets OTC, 650mg, a complex Bi-layer extended released based formulations, is a good addition to our portfolio. We will be launching the product in the Canada market soon.”
The drug will be manufactured at the Granules manufacturing facility located in Gagillapur, Hyderabad. Granules now have a total of 2 ANDS approvals from Health Canada.