01 1Xellia Pharmaceuticals ApS
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
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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amphotericin B manufacturer or Amphotericin B supplier.
A Amphotec manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amphotec, including repackagers and relabelers. The FDA regulates Amphotec manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amphotec 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 Amphotec manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Amphotec supplier is an individual or a company that provides Amphotec active pharmaceutical ingredient (API) or Amphotec finished formulations upon request. The Amphotec suppliers may include Amphotec API manufacturers, exporters, distributors and traders.
click here to find a list of Amphotec suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Amphotec DMF (Drug Master File) is a document detailing the whole manufacturing process of Amphotec active pharmaceutical ingredient (API) in detail. Different forms of Amphotec DMFs exist exist since differing nations have different regulations, such as Amphotec USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amphotec DMF submitted to regulatory agencies in the US is known as a USDMF. Amphotec USDMF includes data on Amphotec's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amphotec USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amphotec suppliers with USDMF on PharmaCompass.
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