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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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How second-generation entrepreneur Priyanka Chigurupati is taking her family's pharma business forward


How second-generation entrepreneur Priyanka Chigurupati is taking her family’s pharma business forward
A second-generation entrepreneur, Priyanka Chigurupati started her career with pharma company Granules India as a marketing manager for a region-specific division and soon moved to head a new API facility and establish the US team for Granules Inc.
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Priyanka Chigurupati says she didn’t have the slightest inkling of what she would be doing before she joined Granules, the family business.
After graduating in bachelor’s of science in business management from Case Western Reserve University in Cleveland, Ohio, she took her interest in fashion forward by pursuing an associate degree in applied science (fashion marketing) at Parsons, the New School of Design. ....

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Granules India gets USFDA nod for generic potassium chloride oral solution


The US drug regulator has approved the ANDA filed by Granules Pharmaceuticals, Inc, a wholly owned foreign arm of Granules India, for potassium chloride oral solution USP, 20 mEq/15 mL (10%) and 40 mEq/15 mL (20%).
The product is bio-equivalent to the reference listed drug product (RLD), potassium chloride oral solution, 20 mEq/15 mL (10%) and 40 mEq/15 mL (20%), of Genus Lifesciences, Inc. The product would be available in bottle of 473 ml and is expected to be launched shortly.
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient. Granules now has a total of 36 ANDA approvals from USFDA (35 final approvals and 1 tentative approvals). ....

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