Granules receives Health Canada nod for arthritis tablets

The drug will be manufactured at the Granules manufacturing facility located at Gagillapur, Hyderabad.

Hyderabad: Hyderabad-based Granules India said it received marketing approval from Health Canada for Acetaminophen Extended-Release Tablets OTC, 650mg for the treatment of arthritis pain.

The drug will be manufactured at the Granules manufacturing facility located at Gagillapur, Hyderabad. The product is a bioequivalent to the reference listed drug, Tylenol Extended Release 650 Tablets.

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Priyanka Chigurupati, ED, Granules USA & Granules Pharmaceuticals, 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 formulation, is a good addition to our portfolio. We will be launching the product in the Canada market soon.”

Granules now have a total of two ANDS (abbreviated new drug submissions) approvals from Health Canada.

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