Drug Approval | February 21, 2025
Lupin receives EIR from USFDA for its Somerset manufacturing facility
the inspection conducted from January 27 to January 31, 2025
the inspection conducted from January 27 to January 31, 2025
Ipratropium Bromide Nasal Solution is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis
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Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru
The inspection was carried out from January 28 to February 1, 2025
This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations
Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
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