01 1Borregaard
01 1CELLOBIOSE OCTAACETATE XP
01 1Norway
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18162
Submission : 2005-03-11
Status : Inactive
Type : IV
10
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A Sunmalt manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sunmalt, including repackagers and relabelers. The FDA regulates Sunmalt manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sunmalt 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 Sunmalt manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sunmalt supplier is an individual or a company that provides Sunmalt active pharmaceutical ingredient (API) or Sunmalt finished formulations upon request. The Sunmalt suppliers may include Sunmalt API manufacturers, exporters, distributors and traders.
click here to find a list of Sunmalt suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sunmalt DMF (Drug Master File) is a document detailing the whole manufacturing process of Sunmalt active pharmaceutical ingredient (API) in detail. Different forms of Sunmalt DMFs exist exist since differing nations have different regulations, such as Sunmalt USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sunmalt DMF submitted to regulatory agencies in the US is known as a USDMF. Sunmalt USDMF includes data on Sunmalt's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sunmalt USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sunmalt suppliers with USDMF on PharmaCompass.
