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Granules India’s arm receives USFDA’s approval for Amphetamine Sulfate Tablets

Granules India’s wholly owned foreign subsidiary — Granules Pharmaceuticals, Inc. has received approval for the Abbreviated New Drug Application (ANDA) from US Food & Drug Administration (USFDA) for Amphetamine Sulfate Tablets USP 5 mg and 10 mg. It is bioequivalent to the reference listed drug product (RLD), Evekeo Tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals, LLC.

Amphetamine Sulfate tablets is a central nervous system stimulant used to treat sleep disorder, increase attention, decrease impulsiveness and hyperactivity in patients with Attention Deficit Hyperactivity Disorder (ADHD).

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

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