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Granules India gains after USFDA nod for migraine drug


Granules India rose 1.57% to Rs 326.90 after the company said that US drug regulator has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC).The product is bioequivalent to the reference listed drug product (RLD), Excedrin migraine tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare.
The drug is indicated for treating migraine. The product will be manufactured at the company s Hyderabad facility and is expected to be launched shortly.
Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc., commenting on the approval, said: We are pleased to announce approval of acetaminophen, aspirin and caffeine tablets, emphasizing our focus on building sustainable OTC product portfolio in the US market. We received approval for this triple combination product within 14 months from filing. With this, we have received three ANDA approvals over the past month. ....

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Granules India Limited announces approval of Acetaminophen, Aspirin and Caffeine Tablets (OTC)


Granules India Limited announces approval of Acetaminophen, Aspirin and Caffeine Tablets (OTC)
Posted On:
2021-02-24 00:20:48
(Time Zone: Arizona, USA)
Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg/250 mg/65 mg (OTC). It is bioequivalent to the reference listed drug product (RLD), Excedrin Migraine Tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare. The product would be manufactured at our Hyderabad facility and is expected to be launched shortly.
We are pleased to announce approval of Acetaminophen, Aspirin and Caffeine Tablets, emphasizing our focus on building sustainable OTC product portfolio in the US market. We received approval for this triple combination product within 14 months from filing. With this, we have received three ANDA approvals over the past month. said Priyanka ....

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