01 2ALP Pharm
02 2Amneal Pharmaceuticals
03 4JOYANG LABORATORIES
04 2North China Pharmaceutical Huasheng Co Ltd
05 1Pfizer Inc
06 1SIGMA TAU
07 2WORLD JIANGSU INDUSTRY CO LTD
08 5Xellia Pharmaceuticals ApS
09 1Yancheng Youhua Pharma and Chemical Tech Co Ltd
10 2Blank
01 5BACITRACIN
02 1BACITRACIN STERILE USP
03 3BACITRACIN USP
04 1BACITRACIN USP NON-STERILE
05 1BACITRACIN USP, NON-STERILE DRUG SUBSTANCE
06 6BACITRACIN ZINC
07 1BACITRACIN ZINC NON-STERILE BULK DRUG SUBSTANCE
08 1BACITRACIN ZINC STERILE USP
09 1BACITRACIN ZINC USP (NON-STERILE DRUG SUBSTANCE)
10 1BACITRACIN ZINC USP NON-STERILE
11 1BACITRACIN ZINC, STERILE
01 11China
02 5Denmark
03 4U.S.A
04 2Blank
01 11Active
02 11Inactive
01 6Complete
02 16Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24000
Submission : 2010-07-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23999
Submission : 2010-07-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27733
Submission : 2013-11-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23358
Submission : 2009-12-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-06
Pay. Date : 2014-11-10
DMF Number : 28615
Submission : 2014-08-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-07
Pay. Date : 2014-06-13
DMF Number : 28355
Submission : 2014-06-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13608
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-17
Pay. Date : 2012-10-31
DMF Number : 13607
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-10-31
DMF Number : 13341
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-23
Pay. Date : 2013-09-23
DMF Number : 27510
Submission : 2013-09-11
Status : Active
Type : II
A Bacitracin Zinc manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bacitracin Zinc, including repackagers and relabelers. The FDA regulates Bacitracin Zinc manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bacitracin Zinc 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 Bacitracin Zinc manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bacitracin Zinc supplier is an individual or a company that provides Bacitracin Zinc active pharmaceutical ingredient (API) or Bacitracin Zinc finished formulations upon request. The Bacitracin Zinc suppliers may include Bacitracin Zinc API manufacturers, exporters, distributors and traders.
click here to find a list of Bacitracin Zinc suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bacitracin Zinc DMF (Drug Master File) is a document detailing the whole manufacturing process of Bacitracin Zinc active pharmaceutical ingredient (API) in detail. Different forms of Bacitracin Zinc DMFs exist exist since differing nations have different regulations, such as Bacitracin Zinc USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bacitracin Zinc DMF submitted to regulatory agencies in the US is known as a USDMF. Bacitracin Zinc USDMF includes data on Bacitracin Zinc's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bacitracin Zinc USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bacitracin Zinc suppliers with USDMF on PharmaCompass.
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