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 centre in Pune, Maharashtra. The inspection was ... Read More
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 from the US Food and Drug Administration ... Read More
Lupin reports completion of FDA inspection at Vizag plant with no observations
Lupin said that the US Food and Drug Administration (FDA) has wrapped up a pre-approval and GMP inspection of its API manufacturing plant in Visakhapatnam, ... Read More
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, 15 mg, and 20 mg from the ... Read More
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 application (ANDA) for Thiamine Hydrochloride Injection USP, ... Read More
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 in 5 mL and 10 mL Multi-dose ... Read More
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 US Food and Drug Administration (FDA). Vigabatrin ... Read More
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 the treatment of Friedreich’s ataxia, a neuromuscular ... Read More
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 Drug Administration (FDA) Acyclovir Cream, 5% is ... Read More
Zydus Lifesciences bags FDA final approval for Apixaban Tablets
Zydus Lifesciences has bagged final approval from the US Food and Drug Administration (FDA) for Apixaban Tablets, 2.5mg and 5mg, a generic version of Eliquis ... Read More