USFDA nod for Granules’ generic pain relief drug

Drug maker Granules India on Thursday said the US Food and Drug Administration (USFDA) has approved its Abbreviated New Drug Application for Acetaminophen 650 mg tablets, extended release (ER).

A generic version of Tylenol 650 mg tablets, ER, Acetaminophen 650 mg ER tablets are used primarily for temporary pain management, including arthritis relief, the Hyderabad-based firm said. Granules India is the only supplier that is backward integrated up to the API (active pharmaceutical ingredient) on this product, the company claimed.

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