01 1ALP Pharm
02 1BrightGene Bio-Medical Technology Co.,Ltd
03 1Curia
04 1Emcure Pharmaceuticals
05 2GLAND PHARMA LIMITED
06 1H. Lundbeck AS
07 1Mitsubishi Tanabe Pharma
08 1ScinoPharm Taiwan, Ltd
09 1Tianjin Weijie Pharmaceutical Co., Ltd.
01 121 S ARGATROBAN
02 4ARGATROBAN
03 1ARGATROBAN HYDRATE
04 1ARGATROBAN MONOHYDRATE (PROCESS-II)
05 1ARGATROBAN MONOHYDRATE USP
06 1ARGATROBAN USP
07 1MCI-9038 ARGATROBAN DRUG SUB.
01 3China
02 1Denmark
03 3India
04 1Japan
05 1Taiwan
06 1U.S.A
01 8Active
02 2Inactive
01 5Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25893
Submission : 2012-02-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-01
Pay. Date : 2021-04-14
DMF Number : 35491
Submission : 2020-12-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-18
Pay. Date : 2013-10-25
DMF Number : 20760
Submission : 2007-08-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25765
Submission : 2012-03-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-15
Pay. Date : 2014-11-28
DMF Number : 28030
Submission : 2014-05-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-12
Pay. Date : 2013-03-26
DMF Number : 25400
Submission : 2011-10-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-05
Pay. Date : 2013-09-26
DMF Number : 21304
Submission : 2008-01-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7801
Submission : 1988-12-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22935
Submission : 2009-07-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31131
Submission : 2016-12-05
Status : Active
Type : II
A Argatroban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Argatroban, including repackagers and relabelers. The FDA regulates Argatroban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Argatroban 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 Argatroban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Argatroban supplier is an individual or a company that provides Argatroban active pharmaceutical ingredient (API) or Argatroban finished formulations upon request. The Argatroban suppliers may include Argatroban API manufacturers, exporters, distributors and traders.
click here to find a list of Argatroban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Argatroban DMF (Drug Master File) is a document detailing the whole manufacturing process of Argatroban active pharmaceutical ingredient (API) in detail. Different forms of Argatroban DMFs exist exist since differing nations have different regulations, such as Argatroban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Argatroban DMF submitted to regulatory agencies in the US is known as a USDMF. Argatroban USDMF includes data on Argatroban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Argatroban USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Argatroban suppliers with USDMF on PharmaCompass.
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