Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
01 1Metrochem API Private Limited
02 1Ami Lifesciences Private Limited
03 1Daiichi Sankyo
04 1HONOUR LAB LTD
05 1Jiangxi Synergy Pharmaceutical
06 1MSN Laboratories
07 1Morepen Laboratories
08 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
09 1Zhejiang Huahai Pharmaceutical
10 1Zhejiang Supor Pharmaceuticals Co., LTD
11 1Zydus Lifesciences
01 1DU-176B DRUG SUBSTANCE
02 1EDOXABAN TOSILATE
03 2EDOXABAN TOSYLATE
04 1EDOXABAN TOSYLATE (MONOHYDRATE)
05 6EDOXABAN TOSYLATE MONOHYDRATE
01 4China
02 6India
03 1Japan
01 10Active
02 1Inactive
01 4Complete
02 7Blank
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37896
Submission : 2022-12-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38201
Submission : 2023-03-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-13
Pay. Date : 2017-12-29
DMF Number : 32401
Submission : 2018-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38513
Submission : 2023-09-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36084
Submission : 2021-07-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32330
Submission : 2017-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-17
Pay. Date : 2021-12-29
DMF Number : 36062
Submission : 2021-07-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-24
Pay. Date : 2023-12-08
DMF Number : 39074
Submission : 2023-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32963
Submission : 2018-07-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-29
Pay. Date : 2018-08-31
DMF Number : 33133
Submission : 2018-09-27
Status : Active
Type : II
A Edoxaban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edoxaban, including repackagers and relabelers. The FDA regulates Edoxaban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edoxaban 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 Edoxaban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Edoxaban supplier is an individual or a company that provides Edoxaban active pharmaceutical ingredient (API) or Edoxaban finished formulations upon request. The Edoxaban suppliers may include Edoxaban API manufacturers, exporters, distributors and traders.
click here to find a list of Edoxaban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Edoxaban DMF (Drug Master File) is a document detailing the whole manufacturing process of Edoxaban active pharmaceutical ingredient (API) in detail. Different forms of Edoxaban DMFs exist exist since differing nations have different regulations, such as Edoxaban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Edoxaban DMF submitted to regulatory agencies in the US is known as a USDMF. Edoxaban USDMF includes data on Edoxaban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Edoxaban USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Edoxaban suppliers with USDMF on PharmaCompass.
We have 11 companies offering Edoxaban
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