Amneal Pharmaceuticals
Overview
Amneal Pharmaceuticals is a publicly traded company specializing in the development, manufacture, and distribution of generic and specialty pharmaceutical products. With a commitment to providing affordable medication, the company has established a broad portfolio addressing a wide range of therapeutic areas.
Therapeutic areas
API / Drug Master Files
Amneal Pharmaceuticals 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.
- GLATIRAMER ACETATEActive2013-12-12
FDA compliance signals
32 FDA enforcement records linked to this company.
- recall — Class II2026-04-08
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
- recall — Class I2026-04-08
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
- recall — Class II2025-09-10
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- recall — Class II2025-09-10
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- recall — Class II2025-09-10
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- recall — Class II2025-09-10
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- recall — Class II2025-09-10
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
- recall — Class I2025-06-18
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
- recall — Class I2025-05-14
Presence of Particulate Matter
- recall — Class III2024-08-14
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
- recall — Class II2019-12-18
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- recall — Class II2019-12-18
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- recall — Class II2019-12-18
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- recall — Class II2019-12-18
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- recall — Class II2019-12-18
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
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