Overview

FRESENIUS KABI IPSUM SRL is an active pharmaceutical ingredient (API) supplier with 28 active FDA Type II Drug Master Files, covering AMOXICILLIN SODIUM STERILE; AMPICILLIN SODIUM STERILE; AMPICILLIN SODIUM/SULBACTAM SODIUM; AMPICILLIN TRIHYDRATE STERILE; AVIBACTAM SODIUM STERILE; AZTREONAM NON STERILE ALPHA.

API / Drug Master Files

FRESENIUS KABI IPSUM SRL holds 28 active (28 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.

  • AZTREONAM NON STERILE ALPHAActive2025-04-24
  • PENICILLIN G BENZATHINE LECITHIN COATED STERILEActive2025-03-17
  • ICATIBANT ACETATEActive2024-06-24
  • AVIBACTAM SODIUM STERILEActive2024-02-09
  • CALCITONIN SALMONActive2023-12-20
  • CEFTAZIDIME PENTAHYDRATE STERILE BUFFERED / AVIBACTAM SODIUM STERILE (4:1)Active2023-12-11
  • AMOXICILLIN SODIUM STERILEActive2023-05-17
  • CLOXACILLIN SODIUMActive2023-04-18
  • DEGARELIX ACETATEActive2023-01-19
  • GLUCAGONActive2022-12-22
  • LIRAGLUTIDEActive2022-01-31
  • PIVMECILLINAM HYDROCHLORIDEActive2021-10-15
  • OCTREOTIDE ACETATEActive2020-12-21
  • BUFFERED PENICILLIN G SODIUM STERILEActive2017-12-22
  • PENICILLIN G SODIUM STERILEActive2017-12-22

Showing 15 of 28 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to FRESENIUS KABI IPSUM SRL in our records. PharmaTek screens the full directory against live FDA enforcement data.

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