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Results For "USFDA"

1211 News Found

Dr. Reddy's issues nationwide recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL in US
News | March 18, 2025

Dr. Reddy's issues nationwide recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL in US

The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 m


Briefs: Alembic Pharma and IOL Chemicals and Pharmaceuticals
Drug Approval | March 07, 2025

Briefs: Alembic Pharma and IOL Chemicals and Pharmaceuticals

USFDA inspection at Alembic Pharma's Bioequivalence facility


Lupin Launches Rivaroxaban Tablets USP, 2.5mg in US
Drug Approval | March 07, 2025

Lupin Launches Rivaroxaban Tablets USP, 2.5mg in US

Rivaroxaban Tablets USP, 2.5 mg, is bioequivalent to Xarelto® Tablets, 2.5 mg of Janssen Pharmaceuticals


Senores Pharmaceuticals acquires 14 ANDAs from Dr. Reddy’s Laboratories
News | March 04, 2025

Senores Pharmaceuticals acquires 14 ANDAs from Dr. Reddy’s Laboratories

The basket acquired, comprises of 13 ANDAs, which are approved by the USFDA and 1 ANDA, which is pending approval from the USFDA


Briefs: Emcure and Relonchem
Drug Approval | February 27, 2025

Briefs: Emcure and Relonchem

USFDA inspection at Emcure Pharmaceuticals API facility


Briefs: Syngene International and Cipla
Drug Approval | February 23, 2025

Briefs: Syngene International and Cipla

Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’


India remains a very important part of our ecosystem: Vaios Barlas, Global Director Healthcare, Clariant and Bhushan Thekedar, Head of Global Business Development Healthcare, Clariant
interviews | February 21, 2025

India remains a very important part of our ecosystem: Vaios Barlas, Global Director Healthcare, Clariant and Bhushan Thekedar, Head of Global Business Development Healthcare, Clariant

We will continue to expand our range of purified excipients, offering pharmaceutical companies a dependable partner


Briefs: Caplin Point Laboratories, Hikal and Cipla
Drug Approval | February 10, 2025

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru


FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections
News | February 08, 2025

FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections

EMBLAVEOTM is the first and only monobactam/?-lactamase inhibitor combination antibiotic therapy approved by the USFDA