01 2Gattefosse
01 1PECEOL
02 1PECEOL ISOTEARIQUE
01 2France
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22516
Submission : 2009-02-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11567
Submission : 1995-06-28
Status : Active
Type : IV
14
PharmaCompass offers a list of Monoolein API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Monoolein manufacturer or Monoolein supplier for your needs.
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A Dur-EM 114 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dur-EM 114, including repackagers and relabelers. The FDA regulates Dur-EM 114 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dur-EM 114 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 Dur-EM 114 supplier is an individual or a company that provides Dur-EM 114 active pharmaceutical ingredient (API) or Dur-EM 114 finished formulations upon request. The Dur-EM 114 suppliers may include Dur-EM 114 API manufacturers, exporters, distributors and traders.
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A Dur-EM 114 DMF (Drug Master File) is a document detailing the whole manufacturing process of Dur-EM 114 active pharmaceutical ingredient (API) in detail. Different forms of Dur-EM 114 DMFs exist exist since differing nations have different regulations, such as Dur-EM 114 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dur-EM 114 DMF submitted to regulatory agencies in the US is known as a USDMF. Dur-EM 114 USDMF includes data on Dur-EM 114's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dur-EM 114 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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