Eugia Steriles receives EIR from US FDA
The inspection was conducted between March 28, 2024 to April 05, 2024
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Browsing Tag
USFDA
Strides Pharma subsidiary receives USFDA approval for 60 mg Fluoxetine tablets
Strides Pharma Global secures approval for Fluoxetine Tablets, completing its portfolio for the US market
Sun Pharma and Moebius Medical gain fast track designation for MM-II for the treatment of…
MM-II is a novel non-opioid product that uses a proprietary suspension of large, empty, multilamellar liposomes which are intended…
Strides gains USFDA approval for Theophylline Extended-Release Tablets, 300 mg and 450 mg
Strides is eligible for 180 days of Competitive Generic Therapy (CGT) exclusivity for Theophylline Extended-Release Tablets, 300…
Dr Reddy’s receives EIR for API manufacturing facility
Inspection concluded at its API manufacturing facility in Srikakulam, Andhra Pradesh
Alembic gains final USFDA approval for Albendazole Tablets USP, 200 mg
Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms…
Lupin launches Mirabegron Extended-Release Tablets in the US
Mirabegron Extended-Release Tablets, 50 mg had estimated annual sales of $ 1,600 million in the US (IQVIA MAT July 2024)
Zydus gains final USFDA approval for Amantadine extended-release capsules 68.5 mg and tentative…
Eligible for 180 days of generic drug exclusivity for Amantadine extended release capsules, 68.5 mg
Zydus receives USFDA warning letter for Jarod facility
Earlier, on July 18, the facility received an OAI status
Zydus Lifesciences receives U.S. FDA approval for Scopolamine Transdermal System
Zydus gains final approval to market Scopolamine Transdermal System, marking its fifth ANDA approval in the transdermal portfolio…