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