Drug Approval | February 03, 2025
Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations
The inspection was carried out from January 28 to February 1, 2025
The inspection was carried out from January 28 to February 1, 2025
The PATHWAY HER2 (4B5) test, the first and only FDA approved companion diagnostic for assessing HER2-low status since 2022, is now also approved to aid in the assessment of HER2-ultralow status for metastatic breast cancer patients.
EBITDA grew 46.9% YoY to Rs. 210.3 crore with EBITDA margin at 18.2%, grew 401 bps YoY and the reported PAT at Rs. 90 crore
The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS
The Acetaminophen and Ibuprofen tablets will be manufactured at the company’s flagship facility in KRSG, Bengaluru
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Mesalazine is used to treat inflammatory bowel disease
This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
The brand Magtein by Threotech has a sales value of approximately US $438 million
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
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