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.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Catalent Pharma Solutions, Inc. is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
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
18 FDA enforcement records linked to this company.
- 4832026-05-22
Written procedures not established/followed
- 4832025-04-22
Investigations of discrepancies, failures
- 4832025-04-22
Written procedures not established/followed
- 4832024-05-24
Cleaning / Sanitizing / Maintenance
- 4832023-01-11
Second person sign off
- 4832022-12-15
Establishment of calibration procedures
- 4832022-12-15
Test methods
- 4832022-12-15
Following/documenting laboratory controls
- 4832022-12-15
Sterility/pyrogens - test methods written, followed
- 4832019-02-22
Written program not followed
- 4832019-02-22
SOPs not followed / documented
- 4832019-02-22
Scientifically sound laboratory controls
- 4832018-06-14
Written in-process control procedures
- 4832018-06-14
Quality control unit review of records
- 4832018-06-14
Procedures for non-sterile drug products
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