ZHUHAI UNITED LABORATORIES CO LTD

Overview

ZHUHAI UNITED LABORATORIES CO LTD is an active pharmaceutical ingredient (API) supplier with 2 active FDA Type II Drug Master Files, covering 6-AMINO-PENICILLANIC ACID (6-APA); AMPICILLIN TRIHYDRATE.

API / Drug Master Files

ZHUHAI UNITED LABORATORIES CO LTD holds 2 active (15 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.

• AMPICILLIN TRIHYDRATEActive2009-06-10
• 6-AMINO-PENICILLANIC ACID (6-APA)Active2008-09-16
• POTASSIUM CLAVULANATE DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1Inactive2014-09-15
• POTASSIUM CLAVULANATE - MICROCRYSTALLINE CELLULOSE (1:1)Inactive2012-05-29
• CEFUROXIME SODIUM USPInactive2012-05-28
• CEFOPERAZONE SODIUM USPInactive2012-05-28
• MEROPENEM FOR INJECTION BULK STERILEInactive2012-04-16
• CEFTRIAXONE SODIUM USPInactive2012-02-29
• CEFOTAXIME SODIUM USPInactive2012-02-29
• MEROPENEM CRUDE NON-STERILEInactive2010-05-28
• SULBACTAM SODIUM USP, NON-STERILEInactive2010-05-03
• 7-AMINOCEPHALOSPORANIC ACID (7-ACA)Inactive2009-06-10
• AMOXICILLIN (COMPACTED)Inactive2008-01-04
• AMOXICILLIN TRIHYDRATE USPInactive2007-05-09
• AMOXICILLIN USP BULK SUBSTANCEInactive2001-04-06

FDA compliance signals

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