01 1Gedeon Richter
01 1DIHYDROLYSERGOL
01 1Hungary
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8802
Submission : 1990-10-24
Status : Inactive
Type : II
A Elymoclavine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elymoclavine, including repackagers and relabelers. The FDA regulates Elymoclavine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elymoclavine 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 Elymoclavine supplier is an individual or a company that provides Elymoclavine active pharmaceutical ingredient (API) or Elymoclavine finished formulations upon request. The Elymoclavine suppliers may include Elymoclavine API manufacturers, exporters, distributors and traders.
click here to find a list of Elymoclavine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Elymoclavine DMF (Drug Master File) is a document detailing the whole manufacturing process of Elymoclavine active pharmaceutical ingredient (API) in detail. Different forms of Elymoclavine DMFs exist exist since differing nations have different regulations, such as Elymoclavine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Elymoclavine DMF submitted to regulatory agencies in the US is known as a USDMF. Elymoclavine USDMF includes data on Elymoclavine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Elymoclavine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Elymoclavine suppliers with USDMF on PharmaCompass.
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