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