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News about "USFDA"
Orchid Pharma's Alathur API Facility Successfully Completes USFDA Inspection
Orchid Pharma has successfully completed a surprise USFDA inspection at its Alathur API facility, securing its status as India’s only USFDA-approved site for Sterile Cephalosporins. The facility also secures EU GMP certificate renewal for Cephalosporin API manufacturing.
USFDA | 20/02/2025 | By Abha
Rznomics Liver Cancer Drug RZ-001 Secures Fast Track Designation from US FDA
Rznomics' anticancer drug RZ-001 has received Fast Track Designation from the US FDA for the treatment of liver cancer – Hepatocellular Carcinoma (HCC), marking its second designation after Glioblastoma (GBM), to accelerate its clinical development.
USFDA | 19/02/2025 | By Abha
Ventris Medical's Backpack Bone Graft Systems Secure FDA 510(k) Clearance
Backpack® represents a new class of biomaterials designed for the optimisation of cell proliferation and bone formation and is used in orthopedic and spinal fusion procedures.
Usfda | 10/01/2025 | By Abha
Shanghai MicuRx's MRX-5 Receives FDA Orphan Drug Designation for NTM Infections
MRX-5 is a novel benzoxazole antibiotic developed for treating mycobacteria infections, particularly infections caused by non-tuberculous mycobacteria (NTM).
USFDA | 03/01/2025 | By Abha
NRx Pharmaceuticals Advances NRX-100 NDA Submission to FDA for Suicidal Depression Treatment
NRX-100 was initially granted Fast Track Designation in 2017 for use in combination with NRX-101 (D-cycloserine/lurasidone) for the treatment of suicidal bipolar depression.
USFDA | 01/01/2025 | By Abha
Alembic Pharmaceuticals Bags USFDA Final Approval for Diltiazem Hydrochloride Capsules
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cardizem CD Extended-Release Capsules, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, of Bausch Health US, LLC.
USFDA | 12/11/2024 | By Aishwarya | 129
Zydus Gets Final Approval from USFDA for Scopolamine Transdermal System
Scopolamine Transdermal System is indicated to prevent nausea and vomiting after anaesthesia, narcotic pain medicines, and surgery.
USFDA | 31/08/2024 | By Aishwarya | 134
Alembic Gets FDA Approval for Betamethasone Valerate Foam
Betamethasone valerate foam, 0.12 percent, is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.
USFDA | 27/08/2024 | By Aishwarya | 202
Rusan Pharma API Plant in Ankleshwar Gets USFDA GMP Approval
Rusan Pharma has announced that the United States Food and Drug Administration (USFDA) has granted Good Manufacturing Practice (GMP) approval for its Active Pharmaceutical Ingredient (API) facility in Ankleshwar (Gujarat, India).
USFDA | 23/07/2024 | By Aishwarya | 167
Terumo BCT Receives FDA Clearance for Innovative Rika Plasma Donation System with iNomi Nomogram
This development marks a key advancement in plasma collection technology, allowing for the determination of plasma collection volume based on an individual donor's height, weight, and hematocrit level at the time of donation.
USFDA | 13/05/2024 | By Abha | 454
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