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01 1Curia
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01 1BULK ETHANOLAMINE OLEATE API IN SOLUTION
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01 1U.S.A
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01 1Active
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01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-27
Pay. Date : 2014-04-14
DMF Number : 28132
Submission : 2014-03-24
Status : Active
Type : II
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PharmaCompass offers a list of Ethanolamine Oleate 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 Ethanolamine Oleate manufacturer or Ethanolamine Oleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ethanolamine Oleate manufacturer or Ethanolamine Oleate supplier.
PharmaCompass also assists you with knowing the Ethanolamine Oleate API Price utilized in the formulation of products. Ethanolamine Oleate API Price is not always fixed or binding as the Ethanolamine Oleate Price is obtained through a variety of data sources. The Ethanolamine Oleate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Monolate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Monolate, including repackagers and relabelers. The FDA regulates Monolate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Monolate 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 Monolate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Monolate supplier is an individual or a company that provides Monolate active pharmaceutical ingredient (API) or Monolate finished formulations upon request. The Monolate suppliers may include Monolate API manufacturers, exporters, distributors and traders.
click here to find a list of Monolate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Monolate DMF (Drug Master File) is a document detailing the whole manufacturing process of Monolate active pharmaceutical ingredient (API) in detail. Different forms of Monolate DMFs exist exist since differing nations have different regulations, such as Monolate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Monolate DMF submitted to regulatory agencies in the US is known as a USDMF. Monolate USDMF includes data on Monolate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Monolate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Monolate suppliers with USDMF on PharmaCompass.