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.
Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older
OneSource operates five cGMP facilities and has a strong track record, with 138 successful regulatory and customer audits to date by all major regulatory bodies
The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS
This certification will open new markets for the Kwality Pharma
The Acetaminophen and Ibuprofen tablets will be manufactured at the company’s flagship facility in KRSG, Bengaluru
This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo
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
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