Lupin US FDA approval for Fluocinolone Acetonide Topical Oil EP News Bureau Aug 2, 2023 This product will be manufactured at Lupin’s Somerset facility in the US
Glenmark gets ANDA approval for Saxagliptin Tablets, 2.5 mg and 5 mg EP News Bureau Aug 1, 2023 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 EP News Bureau Jul 12, 2023 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… EP News Bureau Jul 6, 2023 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 EP News Bureau Jul 3, 2023 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 EP News Bureau Jun 13, 2023 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 EP News Bureau Jun 2, 2023 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 EP News Bureau Jun 1, 2023 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 Reuters May 26, 2023 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 EP News Bureau May 15, 2023 The five-day preapproval inspection of an API was conducted from May 8-12, 2023