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.

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

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