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 : 25908
Submission : 2012-04-02
Status : Inactive
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 : Complete
Rev. Date : 2020-11-05
Pay. Date : 2020-09-29
DMF Number : 30563
Submission : 2016-05-31
Status : Active
Type : II
A Alvimopan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alvimopan, including repackagers and relabelers. The FDA regulates Alvimopan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alvimopan 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 Alvimopan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alvimopan supplier is an individual or a company that provides Alvimopan active pharmaceutical ingredient (API) or Alvimopan finished formulations upon request. The Alvimopan suppliers may include Alvimopan API manufacturers, exporters, distributors and traders.
click here to find a list of Alvimopan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alvimopan DMF (Drug Master File) is a document detailing the whole manufacturing process of Alvimopan active pharmaceutical ingredient (API) in detail. Different forms of Alvimopan DMFs exist exist since differing nations have different regulations, such as Alvimopan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alvimopan DMF submitted to regulatory agencies in the US is known as a USDMF. Alvimopan USDMF includes data on Alvimopan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alvimopan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alvimopan suppliers with USDMF on PharmaCompass.
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