Browsing Tag
US FDA
379 posts
Glenmark Pharmaceuticals gets FDA final approval for Compazine generic
Glenmark Pharmaceuticals has bagged final approval for Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg from the…
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…
Marksans Pharma gets FDA final approval for Famotidine Tablets
Marksans Pharma said that it has been granted final approval for the over-the-counter (OTC) use of Famotidine Tablets…
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…