01 2ALP Pharm
02 1Actavis Inc
03 1MSN Laboratories
01 4ALVIMOPAN DIHYDRATE
01 2China
02 1India
03 1Ireland
01 2Active
02 2Inactive
01 2Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-19
Pay. Date : 2016-05-18
DMF Number : 30553
Submission : 2016-05-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24035
Submission : 2010-07-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25908
Submission : 2012-04-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-05
Pay. Date : 2020-09-29
DMF Number : 30563
Submission : 2016-05-31
Status : Active
Type : II
A Entereg manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Entereg, including repackagers and relabelers. The FDA regulates Entereg manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Entereg API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Entereg manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Entereg supplier is an individual or a company that provides Entereg active pharmaceutical ingredient (API) or Entereg finished formulations upon request. The Entereg suppliers may include Entereg API manufacturers, exporters, distributors and traders.
click here to find a list of Entereg suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Entereg DMF (Drug Master File) is a document detailing the whole manufacturing process of Entereg active pharmaceutical ingredient (API) in detail. Different forms of Entereg DMFs exist exist since differing nations have different regulations, such as Entereg USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Entereg DMF submitted to regulatory agencies in the US is known as a USDMF. Entereg USDMF includes data on Entereg's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Entereg USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Entereg suppliers with USDMF on PharmaCompass.
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