Lupin US FDA approval for Fluocinolone Acetonide Topical Oil
This product will be manufactured at Lupin’s Somerset facility in the US
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Browsing Tag
US FDA
Glenmark gets ANDA approval for Saxagliptin Tablets, 2.5 mg and 5 mg
Glenmark’s Saxagliptin Tablets, 2.5 mg and 5 mg, will be distributed in the US by Glenmark Pharma, USA
Lupin gets EIR from US FDA for Pithampur Unit-2 facility
The EIR was issued post the last inspection of the facility conducted from March 21-29, 2023
Amneal Parkinson’s drug IPX203 needs to compete with novel subcutaneous levodopa delivery systems…
Amneal’s IPX203 is an oral extended-release (ER) capsule formulation of levodopa that is designed to sustain levodopa plasma…
In search of consistent quality
Global regulators question perfection, look for the right approach to quality and to understand how a company responds to issues…
Granules India gets USFDA approval for Metoprolol Succinate ER Tablets
Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure
AbbVie’s Rinvoq for Crohn’s Disease to see rapid uptake by healthcare providers: GlobalData
It is expected that the prescribing patterns of Rinvoq by HCPs will follow an ongoing trend by gastroenterologists to be more…
Lupin gets US FDA approval for Diazepam Rectal Gel
It is a generic equivalent of Diastat AcuDialTM Rectal Delivery System, 10 mg and 20 mg, of Bausch Health US
Neuralink, Elon Musk’s brain-implant company, announces US FDA approval for clinical trials
Musk envisions brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as…
US FDA audit at Hikal’s Panoli facility concludes with zero observations
The five-day preapproval inspection of an API was conducted from May 8-12, 2023