XTTRIUM LABORATORIES INC
Overview
XTTRIUM LABORATORIES INC is an active pharmaceutical ingredient (API) supplier with 1 active FDA Type II Drug Master File, covering CHLORHEXIDINE GLUCONATE 20% SOLUTION USP.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances XTTRIUM LABORATORIES 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
XTTRIUM LABORATORIES INC holds 1 active (3 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.
- CHLORHEXIDINE GLUCONATE 20% SOLUTION USPActive1985-04-08
- FACILITIES FOR THE MANUFACTURING OF ANTIMICROBIAL PRODUCTSInactive1991-08-01
- PRE-CLINICAL AND LABORATORY INFORMATION (RHUPH20)Inactive1989-03-01
FDA compliance signals
10 FDA enforcement records linked to this company.
- 4832018-03-15
Procedures for non-sterile drug products
- recall — Class II2017-07-12
CGMP Deviations
- 4832016-07-11
Cleaning / Sanitizing / Maintenance
- 4832016-07-11
Cleaning SOPs/equipment protection
- 4832016-07-11
Representative Samples
- 4832016-07-11
Procedures To Be in Writing
- 4832016-07-11
Complaint Handling Procedure
- 4832016-07-11
Scientifically sound laboratory controls
- 4832013-12-05
Procedures not in writing, fully followed
- warning_letter2009-05-20
FDA Warning Letter (drug product)
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