01 1Abbott Laboratories
01 1MSI-78
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11572
Submission : 1995-07-07
Status : Inactive
Type : II
94
PharmaCompass offers a list of Cytolex 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 Cytolex manufacturer or Cytolex supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cytolex manufacturer or Cytolex supplier.
A Cytolex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cytolex, including repackagers and relabelers. The FDA regulates Cytolex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cytolex 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 Cytolex supplier is an individual or a company that provides Cytolex active pharmaceutical ingredient (API) or Cytolex finished formulations upon request. The Cytolex suppliers may include Cytolex API manufacturers, exporters, distributors and traders.
click here to find a list of Cytolex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Cytolex DMF (Drug Master File) is a document detailing the whole manufacturing process of Cytolex active pharmaceutical ingredient (API) in detail. Different forms of Cytolex DMFs exist exist since differing nations have different regulations, such as Cytolex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cytolex DMF submitted to regulatory agencies in the US is known as a USDMF. Cytolex USDMF includes data on Cytolex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cytolex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cytolex suppliers with USDMF on PharmaCompass.
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