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.
Core services & business areas
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Amneal 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
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
33 FDA enforcement records linked to this company.
- recall — Class III2026-06-17
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
- 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
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