01 1Hebei Shengxue Dacheng Pharmaceutical Co
02 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
03 1Xellia Pharmaceuticals ApS
01 2COLISTIMETHATE SODIUM
02 1COLISTIMETHATE SODIUM USP
01 2China
02 1Denmark
01 3Active
01 3Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-29
Pay. Date : 2020-09-10
DMF Number : 35177
Submission : 2020-09-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-12
Pay. Date : 2019-05-16
DMF Number : 28350
Submission : 2014-05-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13363
Submission : 1998-09-01
Status : Active
Type : II
A Colistimethate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Colistimethate Sodium, including repackagers and relabelers. The FDA regulates Colistimethate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Colistimethate Sodium 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 Colistimethate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Colistimethate Sodium supplier is an individual or a company that provides Colistimethate Sodium active pharmaceutical ingredient (API) or Colistimethate Sodium finished formulations upon request. The Colistimethate Sodium suppliers may include Colistimethate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Colistimethate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Colistimethate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Colistimethate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Colistimethate Sodium DMFs exist exist since differing nations have different regulations, such as Colistimethate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Colistimethate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Colistimethate Sodium USDMF includes data on Colistimethate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Colistimethate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Colistimethate Sodium suppliers with USDMF on PharmaCompass.
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