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