Xellia Delivering Reliable Anti-Infective Solutions Through Expertise, Quality, and Uninterrupted Global Supply.
01 4Xellia Pharmaceuticals
02 2ALP Pharm
03 2Amneal Pharmaceuticals
04 4JOYANG LABORATORIES
05 2North China Pharmaceutical Huasheng Co Ltd
06 1Pfizer Inc
07 1SIGMA TAU
08 2WORLD JIANGSU INDUSTRY CO LTD
09 1Yancheng Youhua Pharma and Chemical Tech Co Ltd
10 2Blank
Xellia Delivering Reliable Anti-Infective Solutions Through Expertise, Quality, and Uninterrupted Global Supply.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-10-31
DMF Number : 13341
Submission : 1998-09-01
Status :
Type : II
Xellia Delivering Reliable Anti-Infective Solutions Through Expertise, Quality, and Uninterrupted Global Supply.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-07
Pay. Date : 2014-06-13
DMF Number : 28355
Submission : 2014-06-20
Status :
Type : II
Xellia Delivering Reliable Anti-Infective Solutions Through Expertise, Quality, and Uninterrupted Global Supply.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13608
Submission : 1998-09-01
Status :
Type : II
Xellia Delivering Reliable Anti-Infective Solutions Through Expertise, Quality, and Uninterrupted Global Supply.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-17
Pay. Date : 2012-10-31
DMF Number : 13607
Submission : 1998-09-01
Status :
Type : II
21
PharmaCompass offers a list of Bacitracin Zinc API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Bacitracin Zinc manufacturer or Bacitracin Zinc supplier for your needs.
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A Baciguent manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Baciguent, including repackagers and relabelers. The FDA regulates Baciguent manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Baciguent API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Baciguent supplier is an individual or a company that provides Baciguent active pharmaceutical ingredient (API) or Baciguent finished formulations upon request. The Baciguent suppliers may include Baciguent API manufacturers, exporters, distributors and traders.
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A Baciguent DMF (Drug Master File) is a document detailing the whole manufacturing process of Baciguent active pharmaceutical ingredient (API) in detail. Different forms of Baciguent DMFs exist exist since differing nations have different regulations, such as Baciguent USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Baciguent DMF submitted to regulatory agencies in the US is known as a USDMF. Baciguent USDMF includes data on Baciguent's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Baciguent USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Baciguent suppliers with USDMF on PharmaCompass.
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