Drug Approval | March 05, 2025
Unichem Laboratories receives 4 observations from USFDA for Pithampur API facility
The company will provide the necessary response on these observations to USFDA within stipulated 15 days
The company will provide the necessary response on these observations to USFDA within stipulated 15 days
The observations issued are neither repeated observations nor related to data integrity
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure
Ibuprofen and famotidine combination is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis
The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated
the inspection conducted from January 27 to January 31, 2025
Observations are largely around improvement of procedures and practices
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
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