Xellia Pharmaceuticals
Overview
Xellia Pharmaceuticals is a pharmaceutical company headquartered in Copenhagen, Denmark, founded in 1903, with 1,001-5,000 employees.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances Xellia Pharmaceuticals 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
Xellia Pharmaceuticals 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.
- GRAMICIDIN, USPActive2004-07-12
- VANCOMYCIN HYDROCHLORIDEActive1998-09-01
FDA compliance signals
5 FDA enforcement records linked to this company.
- recall — Class II2021-09-01
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
- recall — Class II2021-09-01
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.
- 4832018-05-08
Procedures for sterile drug products
- 4832018-05-08
Investigations of discrepancies, failures
- 4832018-05-08
Procedures not in writing, fully followed
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