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.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances NOVARTIS PHARMACEUTICALS CORP is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
NOVARTIS PHARMACEUTICALS CORP holds 8 active (21 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.
- 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
- TESSALON DRUG SUBSTANCE, (BENZONATATE, USP)Inactive1997-03-14
Showing 15 of 21 Drug Master Files.
FDA compliance signals
42 FDA enforcement records linked to this company.
- 4832024-08-08
Computer control of master formula records
- 4832024-08-08
Procedures not in writing, fully followed
- 4832024-08-08
Scientifically sound laboratory controls
- 4832024-08-08
Procedures for sterile drug products
- recall — Class I2023-12-13
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
- recall — Class I2023-09-27
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
- recall — Class II2022-10-05
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
- recall — Class III2022-06-15
Failed Impurities/Degradation Specifications.
- recall — Class III2022-06-15
Failed Impurities/Degradation Specifications.
- recall — Class III2022-06-15
Failed Impurities/Degradation Specifications.
- recall — Class III2022-06-15
Failed Impurities/Degradation Specifications.
- 4832019-08-21
Procedures for sterile drug products
- 4832019-08-21
Extent of discrepancy, failure investigations
- 4832019-08-21
Items to cover on annual reviews
- 4832019-08-21
Control procedures to monitor and validate performance
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