Jubilant HollisterStier LLC
Overview
Jubilant HollisterStier LLC is a global pharmaceutical and life sciences company offering contract manufacturing services. As a subsidiary of Jubilant Pharma, it specializes in providing sterile injectable, allergenic extract, and non-sterile production and manufacturing services along with research and development support.
Therapeutic areas
API / Drug Master Files
Jubilant HollisterStier LLC holds 2 active (2 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.
- STERILE EMPTY VIALSActive2011-11-15
- STERILE EVACUATED VIALSActive2011-08-04
FDA compliance signals
33 FDA enforcement records linked to this company.
- 4832015-07-31
Investigations of discrepancies, failures
- 4832014-04-15
Drug products - samples representative, identified properly
- 4832014-04-15
Procedures not in writing, fully followed
- 4832014-04-15
Procedures To Be in Writing
- 4832014-04-15
Computer control of master formula records
- 4832014-04-15
Mixing adequacy
- 4832014-04-15
Training--operations, GMPs, written procedures
- 4832014-04-15
Sterility/pyrogens - test methods written, followed
- 4832014-04-15
Complete Test Data
- 4832014-04-15
Calculations performed are in the records
- 4832014-04-15
Cleaning System
- 4832014-04-15
Absence of Written Procedures
- 4832014-04-15
Microbiological testing
- 4832014-04-15
Signatures and dates--person who performs test
- 4832014-04-15
Lab written procedures
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