JUNGBUNZLAUER LADENBURG GMBH

Overview

JUNGBUNZLAUER LADENBURG GMBH is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering ANHYDROUS CITRIC ACID; TRIPOTASSIUM CITRATE MONOHYDRATE, USP; TRISODIUM CITRATE DIHYDRATE.

API / Drug Master Files

JUNGBUNZLAUER LADENBURG GMBH holds 3 active (4 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.

• TRISODIUM CITRATE DIHYDRATEActive2018-07-12
• ANHYDROUS CITRIC ACIDActive2009-08-28
• TRIPOTASSIUM CITRATE MONOHYDRATE, USPActive2000-05-05
• MANUFACTURING, FACILITIES, OPERATING PROCEDURES AND PERSONNALInactive2000-05-08

FDA compliance signals

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