01 1AstraZeneca
02 1Mallinckrodt Pharmaceuticals
01 1EXENDIN-4
02 1EXENDIN-4 INJECTION DRUG PRODUCT
01 1Ireland
02 1United Kingdom
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13157
Submission : 1998-08-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13932
Submission : 1999-01-08
Status : Inactive
Type : II
A bydureon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of bydureon, including repackagers and relabelers. The FDA regulates bydureon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. bydureon API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A bydureon supplier is an individual or a company that provides bydureon active pharmaceutical ingredient (API) or bydureon finished formulations upon request. The bydureon suppliers may include bydureon API manufacturers, exporters, distributors and traders.
click here to find a list of bydureon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A bydureon DMF (Drug Master File) is a document detailing the whole manufacturing process of bydureon active pharmaceutical ingredient (API) in detail. Different forms of bydureon DMFs exist exist since differing nations have different regulations, such as bydureon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A bydureon DMF submitted to regulatory agencies in the US is known as a USDMF. bydureon USDMF includes data on bydureon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The bydureon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of bydureon suppliers with USDMF on PharmaCompass.
We have 2 companies offering bydureon
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?