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.

Granules India received ANDA approval for Venlafaxine ER capsules

Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder

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

Briefs: Dr. Reddy's Laboratories and Max Healthcare Institute

Dr. Reddy's Laboratories has been issued a Form 483 with four observations

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

Wacker acquires Spain-based biotech firm ADL BioPharma

The acquisition of ADL BioPharma now makes WACKER owner of the entire plant, with total fermentation capacities of just under 3,000 cubic meters

Briefs: Dr. Reddy's Laboratories

USFDA has issued Form 483 with one observation

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