Tris Pharma, Inc.
Overview
Tris Pharma, Inc. is a leading pharmaceutical company specializing in the development and commercialization of innovative drug delivery technologies. The company focuses on improving patient outcomes by developing novel drug formulations and therapies.
Therapeutic areas
API / Drug Master Files
Tris Pharma, Inc. holds 8 active (8 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.
- NEXICLON XR (CLONIDINE) EXTENDED-RELEASE TABLETSActive2021-02-19
- KARBINAL ER (CARBINOXAMINE MALEATE) EXTENDED-RELEASE ORAL SUSPENSION EQ. TO 4 MG CARBINOXAMINE MALEATE PER 5 MLActive2019-11-04
- OXYBATE FOR EXTENDED-RELEASE ORAL SUSPENSION (OXYBATE FOR ER OS)Active2018-09-11
- COD-CPM-PSE ER ORAL SUSPENSIONActive2015-11-03
- HCD-CPM-PSEUD ER OS (HYDROCODONE POLISTIREX, CHLORPHENIRAMINE POLISTIREX AND PSEUDOEPHEDRINE POLISTIREX ER ORAL SUSPENSION)Active2015-07-17
- COD-CPM ER ORAL SUSPENSIONActive2013-07-26
- METHYLPHENIDATE ERCT (METHYLPHENIDATE HCI ER CHEWABLE TABLETS)Active2012-04-18
- METHYLPHENIDATE ERL (METHYLPHENIDATE ER POWDER FOR ORAL SUSPENSION)Active2010-07-20
FDA compliance signals
24 FDA enforcement records linked to this company.
- 4832025-11-21
Investigations of discrepancies, failures
- 4832024-03-08
Failure to submit scientific article
- 4832024-03-08
Failure to develop written procedures
- 4832021-06-08
Buildings not maintained in good state of repair
- 4832021-06-08
Failure to meet specifications
- 4832021-06-08
Procedures not in writing, fully followed
- 4832021-06-08
Extent of discrepancy, failure investigations
- 4832021-06-08
Cleaning / Sanitizing / Maintenance
- 4832021-06-08
Protective Apparel Not Worn
- 4832021-06-08
Computer control of master formula records
- recall — Class II2019-07-31
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
- recall — Class II2019-02-20
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
- recall — Class II2019-02-20
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
- recall — Class II2019-02-20
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
- 4832019-01-23
Investigations of discrepancies, failures
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