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 Exenatide Synthetic manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Exenatide Synthetic, including repackagers and relabelers. The FDA regulates Exenatide Synthetic manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Exenatide Synthetic 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 Exenatide Synthetic supplier is an individual or a company that provides Exenatide Synthetic active pharmaceutical ingredient (API) or Exenatide Synthetic finished formulations upon request. The Exenatide Synthetic suppliers may include Exenatide Synthetic API manufacturers, exporters, distributors and traders.
click here to find a list of Exenatide Synthetic suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Exenatide Synthetic DMF (Drug Master File) is a document detailing the whole manufacturing process of Exenatide Synthetic active pharmaceutical ingredient (API) in detail. Different forms of Exenatide Synthetic DMFs exist exist since differing nations have different regulations, such as Exenatide Synthetic USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Exenatide Synthetic DMF submitted to regulatory agencies in the US is known as a USDMF. Exenatide Synthetic USDMF includes data on Exenatide Synthetic's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Exenatide Synthetic USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Exenatide Synthetic suppliers with USDMF on PharmaCompass.
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