Drug Approval | April 24, 2025
Caplin Steriles gets USFDA approval for Phytonadione Injectable Emulsion
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K
Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K
Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure
This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery
He has been associated with Caplin Steriles Ltd., Mylan Laboratories Ltd., Caplin Point Laboratories Ltd., Strides Arcolab Ltd. and Novartis Vaccines and Diagnostics
The inspection was concluded with zero observations
The comprehensive criteria encompasses evaluation of debt management, sales growth, earnings-per-share performance, as well as returns on equity
Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension
The Unit currently caters to emerging markets of Latin America and Africa with a variety of dosage forms
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