01 1Ono Pharmaceutical
01 1SIVELESTAT SODIUM HYDRATE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15270
Submission : 2001-02-13
Status : Inactive
Type : II
A Sivelestat Sodium Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sivelestat Sodium Hydrate, including repackagers and relabelers. The FDA regulates Sivelestat Sodium Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sivelestat Sodium Hydrate 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 Sivelestat Sodium Hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sivelestat Sodium Hydrate supplier is an individual or a company that provides Sivelestat Sodium Hydrate active pharmaceutical ingredient (API) or Sivelestat Sodium Hydrate finished formulations upon request. The Sivelestat Sodium Hydrate suppliers may include Sivelestat Sodium Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sivelestat Sodium Hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sivelestat Sodium Hydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sivelestat Sodium Hydrate active pharmaceutical ingredient (API) in detail. Different forms of Sivelestat Sodium Hydrate DMFs exist exist since differing nations have different regulations, such as Sivelestat Sodium Hydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sivelestat Sodium Hydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sivelestat Sodium Hydrate USDMF includes data on Sivelestat Sodium Hydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sivelestat Sodium Hydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sivelestat Sodium Hydrate suppliers with USDMF on PharmaCompass.
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