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