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Granules now have a complete of two ANDS (abbreviated new drug submissions) approvals from Well being Canada.
Granules India has obtained advertising and marketing approval from Well being Canada for Acetaminophen Prolonged Launch tablets OTC, 650mg for the therapy of Arthritis ache.
The product is a bioequivalent to the reference listed drug Tylenol Prolonged Launch 650 tablets, the drugmaker stated in a launch on Monday.
Govt Director of Granules USA and Granules Prescription drugs, Priyanka Chigurupati stated that the approval was obtained inside eight months of the submitting. “The approval of Acetaminophen Prolonged-Launch Tablets OTC, 650mg, a posh Bi-layer Prolonged Launched primarily based formulations is an efficient addition to our portfolio. We will likely be launching the product within the Canada market quickly,” she stated.
The drug will likely be manufactured on the firm’s manufacturing facility positioned in Gagillapur, Hyderabad. Granules now have a complete of two ANDS (abbreviated new drug submissions) approvals from Well being Canada.
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