Drug Approval | May 31, 2023
Concept Medical gets 4th IDE approval from USFDA
For the treatment of Superficial Femoral Artery
For the treatment of Superficial Femoral Artery
The product is expected to be launched in June 2023
This is the second US FDA GMP inspection of this facility within one year
Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States
The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.
This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites
VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
APP13007 is a novel aqueous nanosuspension formulation for the treatment of inflammation and pain following ocular surgery
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