Drug Approval | February 20, 2025
Orchid Pharma's Alathur API facility successfully completes USFDA inspection
The Alathur facility specializes in the production of Cephalosporin antibiotics
The Alathur facility specializes in the production of Cephalosporin antibiotics
Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved
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
Subscribe To Our Newsletter & Stay Updated
