Pharmacia & Upjohn, Inc.

Overview

Pharmacia & Upjohn, Inc. was a major pharmaceutical company formed by the merger of Pharmacia AB and The Upjohn Company. It was later acquired by Pfizer Inc., a global leader in the pharmaceuticals sector. The company was known for its contributions to the development of innovative therapies in various therapeutic areas.

Therapeutic areas

API / Drug Master Files

Pharmacia & Upjohn, Inc. holds 1 active (38 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.

  • CLINDAMYCIN PALMITATE HYDROCHLORIDE USP KALAMAZOOActive1998-09-01
  • DIHYDROFLUOCINOLONE ACETONIDEInactive2002-08-09
  • DOXORUBICIN HCLInactive2001-07-03
  • VIDARABINEInactive1998-09-01
  • TETRACYCLINE HYDROCHLORIDEInactive1998-09-01
  • AMPICILLIN SODIUMInactive1998-09-01
  • ERYTHROMYCIN STEARATEInactive1998-09-01
  • ERYTHROMYCINInactive1998-09-01
  • 9-AMINOCAMPTOTHECIN ACTIVE DRUG SUBSTANCEInactive1995-02-07
  • MANUFACTURING SITE, FACILITIES, PERSONNLE, AND GENERAL OPERATING PROCEDURES OF NICOTINE CONTAINING PRODUCTS IN HELSINGBORG, SWEDEN.Inactive1993-12-15
  • BIZELESIN (U-77779) DRUG SUBSTANCEInactive1993-11-09
  • FACILITY, PERSONNEL AND OPERATING PROCEDURES IN STOCKHOLM, SWEDENInactive1993-07-30
  • 17-DESOXY OXIDOInactive1993-07-28
  • FACILITY AND OPERATING PROCEDURES IN STOCKHOLM, SWEDENInactive1993-07-12
  • FACILITY AND OPERATING PROCEDURES IN STRANGNAS, SWEDENInactive1993-07-12

Showing 15 of 38 Drug Master Files.

FDA compliance signals

8 FDA enforcement records linked to this company.

  • 4832023-06-16

    Equipment Design, Size and Location

  • 4832023-06-16

    Absence of Written Procedures

  • 4832023-06-16

    Validation lacking for sterile drug products

  • 4832023-06-16

    Buildings of Suitable Size, Construction, Location

  • 4832023-06-16

    Authority lacking to review records, investigate errors

  • 4832023-06-16

    Cleaning System

  • 4832023-06-16

    Sanitation--buildings not clean, free of infestation

  • recall — Class II2013-06-26

    Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflective flakes consistent with delamination of the glass vial.

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