Lonza Group AG

Overview

Lonza Group AG is a leading global provider of integrated healthcare solutions. With a focus on pharma and biotech industries, Lonza offers a comprehensive range of services from development to manufacturing. The company is known for its expertise in biologics, cell and gene therapy, and custom manufacturing.

Therapeutic areas

API / Drug Master Files

Lonza Group AG holds 6 active (55 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.

• VOCLOSPORINActive2020-04-06
• NIACINAMIDE FOR ORAL USEActive2016-06-13
• MC-VAL-ALA-PBDActive2016-02-19
• FLUVOXAMINE MALEATE (SV-006)Active2011-08-05
• SIROLIMUSActive2006-09-28
• DEXMETHYLPHENIDATE HYDROCHLORIDE (DMP.HCL)Active2004-01-23
• CRUDE SG-3249Inactive2018-01-31
• ETH06 (TRABECTEDIN INTERMEDIATE)Inactive2013-10-31
• VOCLOSPORIN (IE-001)Inactive2009-12-02
• ETH06 (TRABECTEDIN DRUG SUBSTANCE INTERMEDIATE)Inactive2008-05-16
• EC-125 DRUG SUBSTANCEInactive2008-04-07
• EC-037Inactive2005-11-02
• NIACIN USP GRANULAR SPECIALInactive2005-04-11
• EPROSARTAN MESYLATE (ROUTE F1)Inactive2005-02-09
• TRIPROLIDINE HYDROCHLORIDEInactive2004-12-21

Showing 15 of 55 Drug Master Files.

FDA compliance signals

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