01 1Hayashibara
01 1MALTOSE MONOHYDRATE
01 1Japan
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25598
Submission : 2011-12-19
Status : Active
Type : II
A D-Maltose Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D-Maltose Monohydrate, including repackagers and relabelers. The FDA regulates D-Maltose Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D-Maltose Monohydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A D-Maltose Monohydrate supplier is an individual or a company that provides D-Maltose Monohydrate active pharmaceutical ingredient (API) or D-Maltose Monohydrate finished formulations upon request. The D-Maltose Monohydrate suppliers may include D-Maltose Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of D-Maltose Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A D-Maltose Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of D-Maltose Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of D-Maltose Monohydrate DMFs exist exist since differing nations have different regulations, such as D-Maltose Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A D-Maltose Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. D-Maltose Monohydrate USDMF includes data on D-Maltose Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The D-Maltose Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of D-Maltose Monohydrate suppliers with USDMF on PharmaCompass.
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