CKD BIO CORP

Overview

CKD BIO CORP is an active pharmaceutical ingredient (API) supplier with 14 active FDA Type II Drug Master Files, covering ACARBOSE, NON-STERILE BULK DRUG SUBSTANCE; CLAVULANATE POTASSIUM; CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1; CLAVULANATE POTASSIUM WITH SILICON DIOXIDE IN THE RATIO 1:1, NON-STERILE BULK DRUG SUBSTANCE; CYCLOSPORINE, NON-STERILE BULK, USP; DAPTOMYCIN.

Core services & business areas

API / Drug Master Files

CKD BIO CORP holds 14 active (19 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• LACTOBACILLUS ACIDOPHILUSActive2024-10-18
• PERAMIVIR HYDRATEActive2020-08-21
• DAPTOMYCINActive2020-03-27
• EVEROLIMUS, NON-STERILE APIActive2019-08-28
• TACROLIMUS NON STERILE APIActive2016-10-21
• RIFAMYCIN O, NON-STERILE APIActive2012-06-15
• RIFAMYCIN SODIUM NON-STERILE BULKActive2010-03-08
• ACARBOSE, NON-STERILE BULK DRUG SUBSTANCEActive2007-07-31
• CLAVULANATE POTASSIUM WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1Active2005-04-14
• CLAVULANATE POTASSIUM WITH SILICON DIOXIDE IN THE RATIO 1:1, NON-STERILE BULK DRUG SUBSTANCEActive2005-04-14
• CLAVULANATE POTASSIUMActive2003-01-21
• DEMECLOCYCLINE HYDROCHLORIDEActive1998-09-01
• RIFAMPINActive1998-09-01
• CYCLOSPORINE, NON-STERILE BULK, USPActive1996-10-25
• VANCOMYCIN HYDROCHLORIDEInactive2016-09-20

Showing 15 of 19 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to CKD BIO CORP in our records. PharmaTek screens the full directory against live FDA enforcement data.