01 1Merck & Co
01 1DILTIAZEM ER TABLETS
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11161
Submission : 1994-10-24
Status : Inactive
Type : II
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PharmaCompass offers a list of Diltiazem API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Diltiazem manufacturer or Diltiazem supplier for your needs.
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A Diltiazem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diltiazem, including repackagers and relabelers. The FDA regulates Diltiazem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diltiazem 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 Diltiazem manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Diltiazem supplier is an individual or a company that provides Diltiazem active pharmaceutical ingredient (API) or Diltiazem finished formulations upon request. The Diltiazem suppliers may include Diltiazem API manufacturers, exporters, distributors and traders.
click here to find a list of Diltiazem suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Diltiazem DMF (Drug Master File) is a document detailing the whole manufacturing process of Diltiazem active pharmaceutical ingredient (API) in detail. Different forms of Diltiazem DMFs exist exist since differing nations have different regulations, such as Diltiazem USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diltiazem DMF submitted to regulatory agencies in the US is known as a USDMF. Diltiazem USDMF includes data on Diltiazem's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diltiazem USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diltiazem suppliers with USDMF on PharmaCompass.
