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

Active ingredients with DMF or CEP filings

Substances for which CKD BIO CORP holds, or has held, a US FDA Drug Master File or an EU CEP. A filing is not proof of current supply. Open any ingredient to see all its holders, CAS number and product patent dates.

API / Drug Master Files

CKD BIO CORP holds 14 active (19 total) FDA Type II Drug Master Files. A Type II DMF is filed with the FDA to support an active ingredient in drug applications; an active filing can be referenced but is not proof of current supply, and inactive filings are historical.

• 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
• RIFAMPINActive1998-09-01
• DEMECLOCYCLINE HYDROCHLORIDEActive1998-09-01
• CYCLOSPORINE, NON-STERILE BULK, USPActive1996-10-25
• VANCOMYCIN HYDROCHLORIDEInactive2016-09-20
• MYCOPHENOLATE MOFETIL, NON-STERILE BULK DRUG SUBSTANCEInactive2011-05-16
• LOVASTATIN, NON-STERILE BULK, USPInactive2000-05-04
• 7-AMINOCEPHALOSPORANIC ACID, (7-ACA)Inactive1997-02-15
• RIFAMYCIN-SInactive1995-11-16

Registered manufacturing sites (1)

Physical sites registered with the US FDA and resolved to CKD BIO CORP, with any EU/UK GMP documents matched to each site. Headquarters and manufacturing locations can differ.

• CKD Bio Corporation
  Ansan-si, South Korea · API manufacture

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to CKD BIO CORP in our records. Events are linked by company name and identifier, so this is not proof that none exist; check the FDA's own databases before relying on it.