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