Sandoz GmbH
Overview
Sandoz GmbH is a global leader in generic pharmaceuticals and biosimilars. As a subsidiary of the Novartis Group, Sandoz focuses on affordable healthcare solutions worldwide.
Therapeutic areas
API / Drug Master Files
Sandoz GmbH holds 32 active (48 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 TRIHYDRATEActive2026-02-02
- AMOXICILLIN TRIHYDRATEActive2023-06-02
- VICA (PURE)Active2016-10-24
- CEFIXIMEActive2013-09-27
- TEMSIROLIMUSActive2011-05-20
- CEFOTAXIME SODIUM STERILEActive2007-12-27
- CEFPODOXIME PROXETILActive2006-12-26
- MPI-ACAActive2006-08-31
- HEPARIN SODIUMActive2005-08-02
- CEFDINIRActive2005-06-27
- 7-AMCAActive2004-09-10
- VICA, PURE (3-VINYL-ACA)Active2004-05-06
- VICA CRUDEActive2004-02-20
- CEFTRIAXONE SODIUM (STERILE)Active2003-03-12
- CEFTAZIDIME FOR INJECTIONActive2002-08-06
Showing 15 of 48 Drug Master Files.
FDA compliance signals
50 FDA enforcement records linked to this company.
- recall — Class II2025-09-24
cGMP deviations: Temperature excursion during transportation.
- recall — Class II2025-09-17
Temperature Abuse
- recall — Class I2025-07-09
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
- recall — Class I2025-07-09
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
- recall — Class II2022-04-13
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
- recall — Class I2021-12-08
Temperature Abuse; temperature excursion during shipping
- recall — Class II2020-05-13
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
- recall — Class III2019-11-06
Labeling: Incorrect or missing package insert.
- recall — Class III2019-11-06
Labeling: Incorrect or missing package insert.
- recall — Class III2019-11-06
Labeling: Incorrect or missing package insert.
- recall — Class II2019-10-16
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
- recall — Class II2019-10-16
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
- recall — Class II2019-10-16
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
- 4832019-04-16
Investigations of discrepancies, failures
- 4832019-04-16
Lab controls established, including changes
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 14 days.