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.
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
Equipment Design, Size and Location
- 4832015-10-13
Procedures to be written and followed
- 4832015-10-13
Environmental Monitoring System
- 4832015-10-13
Lack of written stability program
- 4832015-10-13
Training , Education , Experience overall
- 4832015-10-13
Cleaning System
- 4832015-10-13
Review of representative number of batches
- 4832015-10-13
Procedures not in writing, fully followed
- 4832015-10-13
Annual visual exams of drug products
- 4832015-10-13
Procedures for sterile drug products
- 4832015-10-13
Representative Samples
- 4832015-10-13
Absence of Written Procedures
- warning_letter2010-10-29
FDA Warning Letter (drug product)
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