01 1ALP Pharm
02 1BIOTIKA a.s.
03 1CULTOR FOOD SCIENCE INC
04 1Hangzhou Zhongmei Huadong Pharmaceutical
05 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
06 1North China Pharmaceutical Huasheng Co Ltd
07 1Shandong Luxi Pharmaceutical Co.,Ltd.
08 1Shandong Ruizhi Pharmaceutical Technology
09 1WORLD JIANGSU INDUSTRY CO LTD
10 2Xellia Pharmaceuticals ApS
11 1Yancheng Youhua Pharma and Chemical Tech Co Ltd
12 1Blank
01 7POLYMYXIN B SULFATE
02 4POLYMYXIN B SULFATE USP
03 1POLYMYXIN B SULFATE, STERILE
04 1Polymyxin B Sulfate USP (Non-Sterile Drug Substance)
01 8China
02 2Denmark
03 1Slovakia
04 1U.S.A
05 1Blank
01 11Active
02 2Inactive
01 4Complete
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23997
Submission : 2010-07-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-29
Pay. Date : 2013-12-11
DMF Number : 23876
Submission : 2010-05-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-20
Pay. Date : 2013-11-08
DMF Number : 22030
Submission : 2008-10-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38019
Submission : 2023-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35892
Submission : 2021-07-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31587
Submission : 2017-03-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 14187
Submission : 1999-06-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13536
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28616
Submission : 2014-09-08
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31683
Submission : 2017-03-21
Status : Active
Type : II
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A Polymyxin B Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polymyxin B Sulfate, including repackagers and relabelers. The FDA regulates Polymyxin B Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polymyxin B Sulfate 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 Polymyxin B Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polymyxin B Sulfate supplier is an individual or a company that provides Polymyxin B Sulfate active pharmaceutical ingredient (API) or Polymyxin B Sulfate finished formulations upon request. The Polymyxin B Sulfate suppliers may include Polymyxin B Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Polymyxin B Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Polymyxin B Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Polymyxin B Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Polymyxin B Sulfate DMFs exist exist since differing nations have different regulations, such as Polymyxin B Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polymyxin B Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Polymyxin B Sulfate USDMF includes data on Polymyxin B Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polymyxin B Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polymyxin B Sulfate suppliers with USDMF on PharmaCompass.
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