Shilpa Medicare Analytical Services Division gets VAI status from USFDA after GMP inspection

This is the second US FDA GMP inspection of this facility within one year

Zydus receives final approval from the USFDA for Ephedrine Sulfate Injection

Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States

Strides Puducherry facility receives EIR from USFDA

The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.

Hikal announces USFDA audit with zero observations

This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites

USFDA approves Astellas' Veozah’ for treatment of vasomotor symptoms due to menopause

VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause

USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’

Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time

Formosa Pharmaceuticals and AimMax Therapeutics announce NDA Submission to USFDA for APP13007

APP13007 is a novel aqueous nanosuspension formulation for the treatment of inflammation and pain following ocular surgery

Zydus receives final approval from the USFDA for Sucralfate Tablets USP, 1 gram

Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA

Pheezee is designed to assess musculoskeletal and neuromuscular health.

USFDA puts on hold Sun Pharma trials on dermatological drug

Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose