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
API / Drug Master Files
AstraZeneca Pharmaceuticals LP holds 5 active (9 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
- BUDESONIDEActive2018-10-10
- GOSERELIN ACETATE IMPLANTActive2017-04-21
- GOSERELIN ACETATEActive2017-04-21
- 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
Investigations of discrepancies, failures
- 4832024-05-31
Complete Test Data
- 4832024-05-31
Procedures not in writing, fully followed
- 4832024-05-31
Complaint Handling Procedure
- 4832023-09-19
Written in-process control procedures
- 4832023-09-19
Complete Test Data
- warning_letter2023-08-04
FDA Warning Letter (drug product)
- 4832022-07-22
Extent of discrepancy, failure investigations
- 4832022-07-22
Procedures for sterile drug products
- 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
Complaint Handling Procedure
- 4832017-08-24
Procedures not in writing, fully followed
- 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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