CorMedix Completes Successful CMC Interaction with the FDA
CorMedix Inc. (CRMD)
NASDAQ:AMEX Investor Relations:
cormedix.com
Company Research
Source: GlobeNewswire
BERKELEY HEIGHTS, N.J., Oct. 16, 2019 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that it has completed its interaction with the FDA related to the chemistry, manufacturing and controls (CMC) package that will be needed to support Neutrolin’s new drug application (NDA). The FDA was supportive of Neutrolin’s proposed manufacturing program, including the active pharmaceutical ingredients (API), the container closure and testing, and indicated that it will conduct a thorough review of all of the CMC information as well as assess the commercial readiness of the various manufacturing facilities at the time of NDA filing. No further CMC meetings with FDA are planned prior to NDA submission. A pre-NDA meeting has now been scheduled and CorMedix is looking forward to discussing with the FDA the fili
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- CorMedix Inc. Announces U.S. Inpatient Commercial Availability of DefenCath® (Taurolidine and Heparin)GlobeNewswire
- Wall Street Analysts Predict a 146.21% Upside in CorMedix (CRMD): Here's What You Should Know [Yahoo! Finance]Yahoo! Finance
CRMD
Earnings
- 3/12/24 - Miss
CRMD
Sec Filings
- 3/20/24 - Form 4
- 3/20/24 - Form 4
- 3/20/24 - Form 4
- CRMD's page on the SEC website