CP Pharmaceuticals Limited

Overview

CP Pharmaceuticals Limited is a UK-based pharmaceutical company specializing in the development and manufacturing of a broad range of prescription medicines and healthcare products. It operates as a subsidiary of Wockhardt Limited, a global pharmaceutical and biotechnology organization.

Core services & business areas

Drug ManufacturingResearch and DevelopmentQuality Control

Therapeutic areas

API / Drug Master Files

CP Pharmaceuticals Limited holds 0 active (1 total) FDA Type II Drug Master File — 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.

  • FACILITY AT WREXHAM, WALESInactive1986-04-30

FDA compliance signals

15 FDA enforcement records linked to this company.

  • eu_noncompliance2023-09-07

    EU GMP Statement of Non-Compliance

  • warning_letter2016-11-16

    FDA Warning Letter (drug product)

  • 4832015-10-13

    Annual visual exams of drug products

  • 4832015-10-13

    Environmental Monitoring System

  • 4832015-10-13

    Representative Samples

  • 4832015-10-13

    Lack of written stability program

  • 4832015-10-13

    Training , Education , Experience overall

  • 4832015-10-13

    Equipment Design, Size and Location

  • 4832015-10-13

    Procedures to be written and followed

  • 4832015-10-13

    Procedures for sterile drug products

  • 4832015-10-13

    Absence of Written Procedures

  • 4832015-10-13

    Cleaning System

  • 4832015-10-13

    Review of representative number of batches

  • 4832015-10-13

    Procedures not in writing, fully followed

  • warning_letter2010-10-29

    FDA Warning Letter (drug product)

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