Xellia Delivering Reliable Anti-Infective Solutions Through Expertise, Quality, and Uninterrupted Global Supply.
01 1Xellia Pharmaceuticals
02 1Ajinomoto Company
03 3Asence Pharma
04 5Bristol Myers Squibb
05 1Gilead Sciences
06 1North China Pharmaceutical Huasheng Co Ltd
07 1Pfizer Inc
08 1Blank
Xellia Delivering Reliable Anti-Infective Solutions Through Expertise, Quality, and Uninterrupted Global Supply.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-13
Pay. Date : 2012-11-19
DMF Number : 13682
Submission : 1998-09-01
Status :
Type : II
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PharmaCompass offers a list of Amphotericin B 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 Amphotericin B manufacturer or Amphotericin B supplier for your needs.
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A Mysteclin-F manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mysteclin-F, including repackagers and relabelers. The FDA regulates Mysteclin-F manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mysteclin-F 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 Mysteclin-F manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Mysteclin-F supplier is an individual or a company that provides Mysteclin-F active pharmaceutical ingredient (API) or Mysteclin-F finished formulations upon request. The Mysteclin-F suppliers may include Mysteclin-F API manufacturers, exporters, distributors and traders.
click here to find a list of Mysteclin-F suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Mysteclin-F DMF (Drug Master File) is a document detailing the whole manufacturing process of Mysteclin-F active pharmaceutical ingredient (API) in detail. Different forms of Mysteclin-F DMFs exist exist since differing nations have different regulations, such as Mysteclin-F USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mysteclin-F DMF submitted to regulatory agencies in the US is known as a USDMF. Mysteclin-F USDMF includes data on Mysteclin-F's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mysteclin-F USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mysteclin-F suppliers with USDMF on PharmaCompass.
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