01 1Olon S.p.A
01 1BEZAFIBRATE
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27497
Submission : 2013-09-03
Status : Active
Type : II
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A Lipox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lipox, including repackagers and relabelers. The FDA regulates Lipox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lipox 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 Lipox manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Lipox supplier is an individual or a company that provides Lipox active pharmaceutical ingredient (API) or Lipox finished formulations upon request. The Lipox suppliers may include Lipox API manufacturers, exporters, distributors and traders.
click here to find a list of Lipox suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Lipox DMF (Drug Master File) is a document detailing the whole manufacturing process of Lipox active pharmaceutical ingredient (API) in detail. Different forms of Lipox DMFs exist exist since differing nations have different regulations, such as Lipox USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lipox DMF submitted to regulatory agencies in the US is known as a USDMF. Lipox USDMF includes data on Lipox's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lipox USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lipox suppliers with USDMF on PharmaCompass.
