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New Drug for Migraine Approved by Colleen Fleiss on February 25, 2021 at 8:03 AM The US Food & Drug Administration (US FDA) has approved Granules Abbreviated New Drug Application (ANDA) for acetaminophen, aspirin, and caffeine tablets, indicated for the treatment of migraine. It is bioequivalent to the Reference Listed Drug (RLD) product, Excedrin Migraine tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare. The product would be manufactured at Granules India s Hyderabad facility and is expected to be launched shortly. ‘Granules Abbreviated New Drug Application (ANDA) for acetaminophen, aspirin, and caffeine tablets, indicated for migraine treatment has been approved by USFDA. ’ We are pleased to announce approval of Acetaminophen, Aspirin and Caffeine tablets, emphasising our focus on building a sustainable OTC product portfolio in the US market. We received approval for this triple combination product ....
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. ....
USFDA approves Granules drug for migraine By IANS | Published on Wed, Feb 24 2021 20:36 IST | 0 Views Migraine Attack (Photo: Pixabay). Image Source: IANS News Hyderabad, Feb 24 : Granules India Ltd on Wednesday announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for acetaminophen, aspirin, and caffeine tablets, indicated for the treatment of migraine. It is bioequivalent to the Reference Listed Drug (RLD) product, Excedrin Migraine tablets, 250 mg/250 mg/65 mg, of GlaxoSmithKline Consumer Healthcare. The product would be manufactured at Granules India s Hyderabad facility and is expected to be launched shortly. We are pleased to announce approval of Acetaminophen, Aspirin and Caffeine tablets, emphasising our focus on building a sustainable OTC product portfolio in the US market. We received approval for this triple combination product within 14 months ....
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 ....
Granules India gets USFDA nod for its Potassium Chloride ER Capsules USP February 17, 2021 × Granules India Limited has announced that the US Food & Drug Administration has approved its Abbreviated New Drug Application (ANDA) for Potassium Chloride Extended-Release Capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg). It is bioequivalent to the reference listed drug product (RLD), Micro-K Extended-Release Capsules, 8 mEq and 10 mEq, of Nesher Pharmaceuticals (USA) LLC. The product would be manufactured at the company’s Hyderabad facility and is expected to be launched shortly. “We are pleased to announce approval of Potassium Chloride Capsule product within the first review cycle of 10 months from the filing date. This is fourth ANDA approval in our Potassium Chloride product basket,” said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc. ....