Breckenridge Pharmaceutical, Inc.
Overview
Breckenridge Pharmaceutical, Inc. is a subsidiary of Towa Pharmaceutical Co., Ltd., providing a variety of high-quality generic pharmaceutical products. The company focuses on delivering value and quality to meet the needs of patients and healthcare professionals.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances Breckenridge Pharmaceutical, 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
Breckenridge Pharmaceutical, Inc. holds 1 active (1 total) FDA Type II Drug Master File — 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.
- ETHACRYNIC ACID USPActive2013-09-03
FDA compliance signals
37 FDA enforcement records linked to this company.
- recall — Class II2026-06-17
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- recall — Class II2026-06-17
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- recall — Class II2026-05-13
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- recall — Class II2025-12-10
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- recall — Class II2025-12-10
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- recall — Class II2025-11-05
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
- recall — Class II2025-09-17
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
- recall — Class II2025-08-20
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- recall — Class II2025-08-13
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
- recall — Class II2025-07-16
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- recall — Class II2025-04-30
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- recall — Class II2025-04-30
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
- recall — Class II2025-04-09
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
- recall — Class II2025-03-19
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- recall — Class II2025-03-19
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
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