Philips expects to reach recall settlements this year: CEO Roy Jakobs Ruchika Sharma2 April 2023 12:00 PM ISTAmsterdam: Dutch health technology company Philips expects to reach settlements this year relating to its global recall of respiratory devices, CEO...
Lupin Hepatitis B virus drug gets USFDA okay Ruchika Sharma1 April 2023 11:23 AM ISTMumbai: Global pharma major Lupin Limited has announced that the company has received approval from the United States Food and Drug Administration...
USFDA inspection: Lupin gets 10 observations for Pithampur facility Ruchika Sharma31 March 2023 11:00 AM ISTMumbai: Lupin has recently announced that US Food and Drug Administration (U.S. FDA) has concluded an inspection with ten observations at...
Glaucoma drug: USFDA nod to Alembic Pharma Brimonidine Tartrate Ophthalmic Solution Ruchika Sharma30 March 2023 4:30 PM ISTBrimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure in...
Glenmark Pharma bags USFDA nod for Calcipotriene and Betamethasone Dipropionate Foam Ruchika Sharma30 March 2023 11:41 AM ISTThe product is a generic version of Enstilar Foam, 0.005%|0.064%, of Leo Pharma AS.
USFDA nod to Granules India postherpetic neuralgia drug Gabapentin Ruchika Sharma29 March 2023 11:46 AM ISTThe medicine is also indicated as adjunctive therapy in the treatment of partial-onset seizures, with and without secondary generalization, in adults...
FDC Roha facility successfully concludes USFDA audit Ruchika Sharma29 March 2023 10:00 AM ISTMumbai: FDC has announced that the US Food and Drug Administration (USFDA) has successfully concluded the audit with no observations (Zero 483’s) at...
Zydus Lifesciences secures USFDA approval for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg Ruchika Sharma28 March 2023 1:15 PM ISTAhmedabad: Zydus Lifesciences Limited has announced that the company has received final approval for Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg,...
Morepen Labs Baddi facility clears USFDA inspection without any adverse observation Ruchika Sharma28 March 2023 12:38 PM ISTGurugram: Morepen Labs has recently announced that the United States Food and Drug Administration (USFDA) has conducted an inspection of the API...
Zydus Lifesciences bags USFDA nod for Levothyroxine Sodium for Injection for myxedema coma treatment Ruchika Sharma28 March 2023 11:42 AM ISTThe drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India.
Lupin pharmacovigilance group concludes USFDA inspection with no observations Ruchika Sharma27 March 2023 3:45 PM ISTMumbai: Global pharma major Lupin Limited has announced that the United States Food and Drug Administration (U.S. FDA) has completed a Post-marketing...
USFDA issues 3 observations for Zydus Lifesciences Ahmedabad facility Ruchika Sharma27 March 2023 2:15 PM ISTThe inspection was a Pre-Approval Inspection as well as a GMP Audit.
