Browsing Tag
US Food and Drug Administration
348 posts
Glenmark Pharmaceuticals set to begin clinical trial of GRC 54276 in US
Glenmark Pharmaceuticals, through its subsidiary Glenmark Specialty, is set to begin a first-in-human, phase 1/2 clinical study of…
FDA concludes inspection at Lupin Bioresearch Centre in Pune
Lupin said that the US Food and Drug Administration (FDA) has concluded an inspection of the company’s bioresearch…
Zydus Lifesciences gets FDA final approval for Erythromycin Tablets generic
Zydus Lifesciences said that it has secured final approval for Erythromycin Tablets USP, 250 mg and 500 mg…
Can Lupin’s clean FDA inspection at its Vizag API plant boost confidence in its global supply reliability?
Lupin’s Vizag API plant clears US FDA inspection with no observations, strengthening its US supply reliability and regulatory track record.
Zydus Lifesciences gets FDA final approval for Olanzapine tablets
Zydus Lifesciences said that it has secured final approval for Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10mg,…
Caplin Point Laboratories subsidiary gets FDA final approval for Thiamine Hydrochloride Injection
Caplin Point Laboratories said that its subsidiary Caplin Steriles has secured final approval for its abbreviated new drug…
Caplin Point Laboratories gets FDA final approval for Rocuronium Bromide Injection
Caplin Point Laboratories said that Caplin Steriles has been given final approval for Rocuronium Bromide Injection, 10 mg/mL…
Zydus Lifesciences gets FDA final approval for Vigabatrin for Oral Solution
Zydus Lifesciences has bagged final approval for seizures drug Vigabatrin for Oral Solution USP, 500 mg from the…
Reata Pharmaceuticals gets Skyclarys FDA approval for Friedreich’s Ataxia
Reata Pharmaceuticals has secured the approval of the US Food and Drug Administration (FDA) for Skyclarys (omaveloxolone) for…
Zydus Lifesciences gets FDA final approval for Acyclovir Cream
Zydus Lifesciences (formerly Cadila Healthcare) has secured final approval for Acyclovir Cream, 5% from the US Food and…