Alkermes Plc
Overview
Alkermes Plc is a global biopharmaceutical company that develops innovative medicines in the fields of neuroscience, oncology, and immunology. The company focuses on creating breakthrough therapies for diseases that have significant unmet medical needs.
Therapeutic areas
API / Drug Master Files
Alkermes Plc holds 4 active (11 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.
- POLYMILL-500® POLYSTYRENE MILLING MEDIAActive2018-01-29
- POLYMILL ® POLYSTYRENE MILLING MEDIAActive2015-07-15
- MICROSPHERE DILUENTActive2009-05-05
- RAPAMYCIN NANOCRYSTAL COLLOIDAL DISPERSION-MEDIA MILLING PROCESSActive1997-07-09
- NCD MELOXICAM BULK INTERMEDIATEInactive2015-12-07
- N1752 EXTENDED RELEASE TABLETS, 18MGInactive2012-08-28
- ELN-CT-105GInactive2009-06-23
- MELOXICAM NANOCRYSTAL® TABLETSInactive2005-09-26
- AVINZA((R) (MORPHINE SULFATE EXTENDED-RELEASE CAPSULES) 30MG, 45MG, 60MG, 75MG, 90MG AND 120MGInactive2003-02-21
- PROLEASE DILUENT USED FOR SUSPENSION OF PROLEASE MICROSPHERE PRODUCTS FOR PRODUCT ADMINISTRATIONInactive1999-03-18
- FLUVOXAMINE MALEATE CR CAPSULESInactive1999-01-22
FDA compliance signals
13 FDA enforcement records linked to this company.
- 4832023-10-19
Complaints reviewed by Quality Control Unit
- 4832023-10-19
Training--operations, GMPs, written procedures
- 4832023-10-19
Computer control of master formula records
- 4832023-10-19
Procedures not in writing, fully followed
- 4832023-10-19
Scientifically sound laboratory controls
- 4832023-10-19
Backup file not maintained
- 4832023-10-19
Validation lacking for sterile drug products
- warning_letter2019-12-02
FDA Warning Letter (drug product)
- recall — Class II2019-10-09
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
- recall — Class II2019-09-04
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
- recall — Class II2014-09-03
Customer complaints for failure to deliver the dose.
- recall — Class II2013-07-31
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
- 4832013-06-28
Procedures for sterile drug products
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