Catalent Pharma Solutions, Inc.
Overview
Catalent Pharma Solutions, Inc. is a leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, and consumer health products. With a strong focus on innovation and customer partnership, Catalent enables better treatments across more than 50 countries worldwide.
Therapeutic areas
API / Drug Master Files
Catalent Pharma Solutions, Inc. holds 0 active (74 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.
- SOFTGELS [OET 10275449 50]Inactive2019-04-11
- SOFTGELS [OET - 10258984]Inactive2018-10-22
- SOFTGELS [OET-10275547-9]Inactive2018-09-28
- SOFTGELS [OET - 10275485]Inactive2017-12-15
- SOFTGELS [OET: 10275427-9]Inactive2017-11-14
- SOFTGELS [OET-10275412]Inactive2017-05-26
- SOFTGELS [OET-10259015-17]Inactive2017-04-13
- SOFTGELS [OET-10258867]Inactive2016-10-20
- SOFTGELS [OET-10259014]Inactive2016-06-24
- SOFTGELS [OET- 10275405-7]Inactive2016-06-21
- SOFTGELS [OET-10275378]Inactive2015-12-15
- SOFTGELS [OET-10275191]Inactive2015-01-16
- SOFTGELS [OET-10275198]Inactive2014-10-22
- SOFTGELS [OET-10275268]Inactive2014-03-24
- SOFTGELS [OET-00775174]Inactive2013-12-12
Showing 15 of 74 Drug Master Files.
FDA compliance signals
17 FDA enforcement records linked to this company.
- 4832025-04-22
Written procedures not established/followed
- 4832025-04-22
Investigations of discrepancies, failures
- 4832024-05-24
Cleaning / Sanitizing / Maintenance
- 4832023-01-11
Second person sign off
- 4832022-12-15
Following/documenting laboratory controls
- 4832022-12-15
Sterility/pyrogens - test methods written, followed
- 4832022-12-15
Establishment of calibration procedures
- 4832022-12-15
Test methods
- 4832019-02-22
Written program not followed
- 4832019-02-22
Scientifically sound laboratory controls
- 4832019-02-22
SOPs not followed / documented
- 4832018-06-14
Quality control unit review of records
- 4832018-06-14
Procedures not in writing, fully followed
- 4832018-06-14
Procedures for non-sterile drug products
- 4832018-06-14
Written in-process control procedures
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