01 1Otsuka Chemical Co Ltd
01 1NO-1886 DRUG SUBSTANCE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13285
Submission : 1998-10-15
Status : Inactive
Type : II
A Lipoprotein Lipase Activator manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lipoprotein Lipase Activator, including repackagers and relabelers. The FDA regulates Lipoprotein Lipase Activator manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lipoprotein Lipase Activator 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 Lipoprotein Lipase Activator supplier is an individual or a company that provides Lipoprotein Lipase Activator active pharmaceutical ingredient (API) or Lipoprotein Lipase Activator finished formulations upon request. The Lipoprotein Lipase Activator suppliers may include Lipoprotein Lipase Activator API manufacturers, exporters, distributors and traders.
click here to find a list of Lipoprotein Lipase Activator suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lipoprotein Lipase Activator DMF (Drug Master File) is a document detailing the whole manufacturing process of Lipoprotein Lipase Activator active pharmaceutical ingredient (API) in detail. Different forms of Lipoprotein Lipase Activator DMFs exist exist since differing nations have different regulations, such as Lipoprotein Lipase Activator USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lipoprotein Lipase Activator DMF submitted to regulatory agencies in the US is known as a USDMF. Lipoprotein Lipase Activator USDMF includes data on Lipoprotein Lipase Activator's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lipoprotein Lipase Activator USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lipoprotein Lipase Activator suppliers with USDMF on PharmaCompass.
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