Drug Approval | August 11, 2024
Caplin Point announces completion of unannounced USFDA inspection
The inspection was concluded with zero observations
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
Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers
The facility will manufacture tablets, capsules, and injections for the oncology segment
This investment will be made by Caplin Point Laboratories Limited and its subsidiaries - Caplin Steriles Limited and Caplin One Labs Limited
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients
The inspection classification was determined by the agency as Voluntary Action Indicated
Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)
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