01 1Mitsubishi Tanabe Pharma
01 1DILTIAZEM MALATE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11077
Submission : 1994-09-09
Status : Inactive
Type : II
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A Diltiazem Malate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diltiazem Malate, including repackagers and relabelers. The FDA regulates Diltiazem Malate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diltiazem Malate 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 Diltiazem Malate supplier is an individual or a company that provides Diltiazem Malate active pharmaceutical ingredient (API) or Diltiazem Malate finished formulations upon request. The Diltiazem Malate suppliers may include Diltiazem Malate API manufacturers, exporters, distributors and traders.
click here to find a list of Diltiazem Malate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Diltiazem Malate DMF (Drug Master File) is a document detailing the whole manufacturing process of Diltiazem Malate active pharmaceutical ingredient (API) in detail. Different forms of Diltiazem Malate DMFs exist exist since differing nations have different regulations, such as Diltiazem Malate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diltiazem Malate DMF submitted to regulatory agencies in the US is known as a USDMF. Diltiazem Malate USDMF includes data on Diltiazem Malate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diltiazem Malate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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