NOVARTIS PHARMACEUTICALS CORP

Overview

NOVARTIS PHARMACEUTICALS CORP is an active pharmaceutical ingredient (API) supplier with 9 active FDA Type II Drug Master Files, covering AMLODIPINE BESYLATE (PROCESS 2); FLUVASTATIN DRUG SUBSTANCE; LIORESAL INTRATHECAL AMPULS/BACLOFEN; MYCOPHENOLIC ACID, DRUG SUBSTANCE INTERMEDIATE; RAPAMYCIN; TERBINAFINE.

API / Drug Master Files

NOVARTIS PHARMACEUTICALS CORP holds 9 active (22 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.

• RAPAMYCINActive2014-03-21
• TERBINAFINEActive2013-06-07
• TOPOTECAN HYDROCHLORIDEActive2011-02-02
• VALSARTAN DRUG SUBSTANCEActive2010-07-02
• FLUVASTATIN DRUG SUBSTANCEActive2010-06-30
• AMLODIPINE BESYLATE (PROCESS 2)Active2009-07-21
• MYCOPHENOLIC ACID, DRUG SUBSTANCE INTERMEDIATEActive2008-08-20
• RAPAMYCINActive2001-11-13
• LIORESAL INTRATHECAL AMPULS/BACLOFENActive1992-04-15
• SMT487 ACETATE (EDOTREOTIDE)Inactive2008-08-08
• PULMONARY DRUG DELIVERY SYSTEM (PDDS) CLINICALInactive2007-10-31
• PULMOSPHERE(R) PLACEBO INHALATION POWDERInactive2005-09-02
• MYCOPHENOLIC ACIDInactive2002-01-24
• RIFAMPINInactive1998-09-01
• MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN STEIN, SWITZERLAND.Inactive1997-12-16

Showing 15 of 22 Drug Master Files.

FDA compliance signals

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