CONCORD BIOTECH LTD

Overview

CONCORD BIOTECH LTD is an active pharmaceutical ingredient (API) supplier with 22 active FDA Type II Drug Master Files, covering CYCLOSPORINE USP; DACTINOMYCIN USP; EVEROLIMUS USP (WITH 2% BHT); LOVASTATIN USP; MIDOSTAURIN; MITOMYCIN USP.

Core services & business areas

Active pharmaceutical ingredients supplied

Substances CONCORD BIOTECH LTD is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

API / Drug Master Files

CONCORD BIOTECH LTD holds 22 active (23 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.

• NYSTATIN USPActive2025-04-19
• VOCLOSPORINActive2024-10-16
• STAUROSPORINE TECHNICALActive2020-12-11
• MIDOSTAURINActive2020-10-27
• TACROLIMUS USP (PROCESS II)Active2020-01-16
• DACTINOMYCIN USPActive2019-11-06
• MITOMYCIN USPActive2019-04-20
• PIMECROLIMUS USPActive2015-09-15
• MYCOPHENOLATE MOFETIL USP (BY AZEOTROPIC DISTILLATION)Active2015-09-04
• MUPIROCIN CALCIUM USPActive2015-01-07
• MUPIROCIN USPActive2014-10-08
• ROMIDEPSINActive2013-11-01
• EVEROLIMUS USP (WITH 2% BHT)Active2013-06-14
• TEMSIROLIMUSActive2011-05-28
• SIROLIMUSActive2011-02-24

Showing 15 of 23 Drug Master Files.

FDA compliance signals