01 1NOF CORPORATION
02 1Nektar Therapeutics
01 1(N-(METHOXYPOLYETHYLENEGLYCOLCARBAMOYL)-1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPHATIDYL-ETHANOLAMINE,MONOSODIUM SALT)
02 1MPEG5000 DPPE
01 1Japan
02 1U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13231
Submission : 1998-09-23
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28248
Submission : 2014-05-01
Status : Active
Type : II
42
PharmaCompass offers a list of Mpeg5000 dppe 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 Mpeg5000 dppe manufacturer or Mpeg5000 dppe supplier for your needs.
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PharmaCompass also assists you with knowing the Mpeg5000 dppe API Price utilized in the formulation of products. Mpeg5000 dppe API Price is not always fixed or binding as the Mpeg5000 dppe Price is obtained through a variety of data sources. The Mpeg5000 dppe Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mpeg5000 dppe manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mpeg5000 dppe, including repackagers and relabelers. The FDA regulates Mpeg5000 dppe manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mpeg5000 dppe 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 Mpeg5000 dppe supplier is an individual or a company that provides Mpeg5000 dppe active pharmaceutical ingredient (API) or Mpeg5000 dppe finished formulations upon request. The Mpeg5000 dppe suppliers may include Mpeg5000 dppe API manufacturers, exporters, distributors and traders.
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A Mpeg5000 dppe DMF (Drug Master File) is a document detailing the whole manufacturing process of Mpeg5000 dppe active pharmaceutical ingredient (API) in detail. Different forms of Mpeg5000 dppe DMFs exist exist since differing nations have different regulations, such as Mpeg5000 dppe USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mpeg5000 dppe DMF submitted to regulatory agencies in the US is known as a USDMF. Mpeg5000 dppe USDMF includes data on Mpeg5000 dppe's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mpeg5000 dppe USDMF is kept confidential to protect the manufacturer’s intellectual property.
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