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Granules India gets USFDA nod for its generic Amphetamine mixed salts

The approval granted by the US Food and Drug Administration (USFDA) to Granules Pharmaceuticals, Inc (GPI), a wholly-owned arm, is for the abbreviated new drug application (ANDA) of amphetamine mixed salts of strengths 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg immediate release tablets, the company said in a statement.

December 30, 2021 / 02:17 PM IST
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Granules India Ltd on Thursday said it has received approval from the US health regulator for its generic Amphetamine mixed salts indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy.

The approval granted by the US Food and Drug Administration (USFDA) to Granules Pharmaceuticals, Inc (GPI), a wholly-owned arm, is for the abbreviated new drug application (ANDA) of amphetamine mixed salts of strengths 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg immediate release tablets, the company said in a statement.

It is bioequivalent to the reference-listed drug product (RLD), Adderall of Teva Women’s Health Inc, it added.

"This product would be manufactured at Granules manufacturing facility in Chantilly, Virginia and is expected to be launched shortly,” the company said.

Commenting on the development, GPI Executive Director, Priyanka Chigurupati said, "It will surely be a valuable addition to our growing product portfolio in the US market."

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Citing IQVIA Health data, the company said Amphetamine mixed salts 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg immediate release tablets had US sales of approximately USD 335 million for the most recent twelve months ending in October 2021.
PTI
first published: Dec 30, 2021 02:17 pm
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