Granules India has received marketing approval from Health Canada for Acetaminophen Extended Release tablets OTC, 650mg for the treatment of Arthritis pain.
The product is a bioequivalent to the reference listed drug Tylenol Extended Release 650 tablets, the drugmaker said in a release on Monday.
Executive Director of Granules USA and Granules Pharmaceuticals, Priyanka Chigurupati said that the approval was received within eight months of the filing. “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,” she said.
The drug will be manufactured at the company’s manufacturing facility located in Gagillapur, Hyderabad. Granules now have a total of two ANDS (abbreviated new drug submissions) approvals from Health Canada.
