Lupin receives EIR from U.S. FDA for its Dabhasa facility
The facility receives U.S. FDA 'No Action Indicated' status
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USFDA
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
US lawmakers question FDAs drug inspection programme in India and China
The lawmakers wrote that theinspection outcomes were the opposite of what would be expected given the poor quality control and…
Lupin receives tentative approval for Olopatadine Hydrochloride Ophthalmic Solution
The drug is a generic equivalent of Pataday Once Daily Relief, 0.7 per cent (OTC)
US FDA completes inspection at Alkem’s Baddi facility
The Inspection was classified as Voluntary Action Indicated (VAI)
Lupin gains EIR from US FDA for its Somerset manufacturing facility
The facility was inspected from May 7 to May 17, 2024