Overview

Pharmaceutical manufacturing site surfaced via EU GMP non-compliance screening (EudraGMDP).

API / Drug Master Files

Everest Organics Limited holds 8 active (8 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.

  • VONOPRAZAN FUMARATEActive2024-10-16
  • OMEPRAZOLE MAGNESIUM USPActive2024-06-19
  • OMEPRAZOLE SULPHIDEActive2023-08-16
  • BEMPEDOIC ACIDActive2023-01-30
  • OMEPRAZOLE USPActive2022-05-30
  • PANTOPRAZOLE SODIUM USPActive2022-02-07
  • ESOMEPRAZOLE MAGNESIUM TRIHYDRATEActive2018-12-20
  • OMEPRAZOLE CHLORO COMPOUNDActive2015-01-22

FDA compliance signals

1 FDA enforcement record linked to this company.

  • eu_noncompliance2024-04-29

    EU GMP Statement of Non-Compliance

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