AstraZeneca Pharmaceuticals LP
Overview
AstraZeneca Pharmaceuticals LP is a global, science-led biopharmaceutical company at the forefront of innovative research across various therapeutic areas. It is a subsidiary of AstraZeneca PLC.
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances AstraZeneca Pharmaceuticals LP 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
AstraZeneca Pharmaceuticals LP holds 4 active (8 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.
- AZD2292Active2022-10-21
- GOSERELIN ACETATEActive2017-04-21
- GOSERELIN ACETATE IMPLANTActive2017-04-21
- METOPROLOL SUCCINATE EXTENDED RELEASE TABLETSActive2016-12-05
- METOPROLOL SUCCINATE EXTENDED RELEASE/HYDROCHLOROTHIAZIDE 25/12.5,50/12.5 AND100/12.5 TABLETSInactive2014-05-21
- LISINOPRIL BULK DRUGInactive1994-04-08
- ATENOLOL ACETATEInactive1987-08-06
- ATENOLOLInactive1987-03-30
FDA compliance signals
20 FDA enforcement records linked to this company.
- 4832024-05-31
Complete Test Data
- 4832024-05-31
Investigations of discrepancies, failures
- 4832024-05-31
Complaint Handling Procedure
- 4832024-05-31
Procedures not in writing, fully followed
- 4832023-09-19
Complete Test Data
- 4832023-09-19
Written in-process control procedures
- warning_letter2023-08-04
FDA Warning Letter (drug product)
- 4832022-07-22
Procedures for sterile drug products
- 4832022-07-22
Extent of discrepancy, failure investigations
- 4832022-07-22
Equipment Design, Size and Location
- recall — Class III2018-03-14
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
- 4832018-01-30
Late submission of 15-day report
- 4832017-08-24
Procedures not in writing, fully followed
- 4832017-08-24
Complaint Handling Procedure
- recall — Class I2017-07-19
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
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