Centaur launches chronic heart failure generic drug In the US
Introduces generic Ivabradine hydrochloride, expanding its US market presence
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Browsing Tag
USFDA
Glenmark Pharmaceuticals receives ANDA approval for Topiramate Capsules USP, 15 mg and 25 mg
The drug as been determined by the FDA to be bioequivalent and therapeutically equivalent to Topamax Capsules
FDA denies approval for Orexo AB’s high-dose Opioid rescue nasal spray, OX124
Setback for Orexo as FDA requests further studies before potential launch
Lupin receives tentative approval from U.S. FDA for Sodium Sulfate, Magnesium Sulfate, and Potassium…
The drug will be manufactured at Lupin’s Nagpur facility, India
Lupin receives EIR from U.S. FDA for its Dabhasa facility
The facility receives U.S. FDA 'No Action Indicated' status
Lupin gains tentative FDA approval for Empagliflozin, Linagliptin, Metformin Hydrochloride ER…
This product will be manufactured at Lupin’s Pithampur facility in India
FDA updates guidance to address spread of misinformation
The revised draft supports the efforts of medical product companies that share this interest in helping the public get factual,…
FDA approves Eli Lilly’s alzheimer’s drug
The drug is targeted at adults in the mild cognitive impairment or mild dementia stage
Alembic Pharma announces USFDA Tentative Approval for Bosutinib Tablets, 100 mg and 500 mg
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD)
IPA hosts Global Pharmaceutical Quality Summit 2024
Global quality experts call for strengthening quality culture and leveraging technological advancements