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