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01 1Gattefosse
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01 1PLUROL OLEIQUE CC 497
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01 1France
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01 1Active
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01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24001
Submission : 2010-07-27
Status : Active
Type : IV
A Plurol Oleique manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Plurol Oleique, including repackagers and relabelers. The FDA regulates Plurol Oleique manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Plurol Oleique 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 Plurol Oleique supplier is an individual or a company that provides Plurol Oleique active pharmaceutical ingredient (API) or Plurol Oleique finished formulations upon request. The Plurol Oleique suppliers may include Plurol Oleique API manufacturers, exporters, distributors and traders.
click here to find a list of Plurol Oleique suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Plurol Oleique DMF (Drug Master File) is a document detailing the whole manufacturing process of Plurol Oleique active pharmaceutical ingredient (API) in detail. Different forms of Plurol Oleique DMFs exist exist since differing nations have different regulations, such as Plurol Oleique USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Plurol Oleique DMF submitted to regulatory agencies in the US is known as a USDMF. Plurol Oleique USDMF includes data on Plurol Oleique's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Plurol Oleique USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Plurol Oleique suppliers with USDMF on PharmaCompass.
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