trending Market Intelligence /marketintelligence/en/news-insights/trending/af38wqw0f8tke003_7t3cg2 content
BY CONTINUING TO USE THIS SITE, YOU ARE AGREEING TO OUR USE OF COOKIES. REVIEW OUR
PRIVACY & COOKIE NOTICE
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *

* Required

In this list

Ethanol manufacturer for Citius' Mino-Lok submits drug master file with FDA

Street Talk Episode 41 - How to Win the Funding Battle, Use Fintech to Play Offense

Forward Spark Spreads Suggest Rising Profitability Of US Renewables As Sector Matures

MA Activity The Big Story In Mature Online Video Platform Market

Martina Cheung Backs The Quality Program


Ethanol manufacturer for Citius' Mino-Lok submits drug master file with FDA

Citius Pharmaceuticals Inc. assisted the manufacturer of the active ethanol component of Mino-Lok in filing a type II drug master file with the U.S. FDA.

Mino-Lok is being developed as an adjunctive therapy to treat catheter-related or central line-associated bloodstream infection along with appropriate systemic antibiotics to salvage infected central venous catheters to preserve central venous access and avoid the complications and morbidities associated with catheter removal and reinsertion.

The manufacturer in question provides exclusivity to Citius Pharmaceuticals.

The filing is reserved for products intended for use as active pharmaceutical ingredients, and such products must meet strict FDA manufacturing and testing standards. It was determined that ethanol is an active component of Mino-Lok and not just an excipient.

In addition, the drug master file allows the company to cross-reference all manufacturing information related to the ethanol production in their regulatory applications associated with Mino-Lok therapy.

Mino-Lok is still under investigation and not approved for commercial use.