01 1Simafex
01 1Cyclam
01 1France
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21071
Submission : 2007-11-22
Status : Active
Type : II
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PharmaCompass offers a list of Cyclam 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 Cyclam manufacturer or Cyclam supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cyclam manufacturer or Cyclam supplier.
A Cyclam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cyclam, including repackagers and relabelers. The FDA regulates Cyclam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cyclam 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 Cyclam supplier is an individual or a company that provides Cyclam active pharmaceutical ingredient (API) or Cyclam finished formulations upon request. The Cyclam suppliers may include Cyclam API manufacturers, exporters, distributors and traders.
click here to find a list of Cyclam suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cyclam DMF (Drug Master File) is a document detailing the whole manufacturing process of Cyclam active pharmaceutical ingredient (API) in detail. Different forms of Cyclam DMFs exist exist since differing nations have different regulations, such as Cyclam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cyclam DMF submitted to regulatory agencies in the US is known as a USDMF. Cyclam USDMF includes data on Cyclam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cyclam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cyclam suppliers with USDMF on PharmaCompass.
