Ipratropium Bromide Nasal Solution is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis
The inspection was carried out from January 28 to February 1, 2025
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
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
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats
Biocon Biologics remains committed to global standards of quality and compliance
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