01 1Xiamen SINOPEG Biotech
01 1METHOXYPOLY (ETHYLENE GLYCOL) SUCCINIMIDYL CARBONATE 5K
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31760
Submission : 2017-04-20
Status : Active
Type : II
A m-PEG5-succinimidyl carbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of m-PEG5-succinimidyl carbonate, including repackagers and relabelers. The FDA regulates m-PEG5-succinimidyl carbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. m-PEG5-succinimidyl carbonate 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 m-PEG5-succinimidyl carbonate supplier is an individual or a company that provides m-PEG5-succinimidyl carbonate active pharmaceutical ingredient (API) or m-PEG5-succinimidyl carbonate finished formulations upon request. The m-PEG5-succinimidyl carbonate suppliers may include m-PEG5-succinimidyl carbonate API manufacturers, exporters, distributors and traders.
click here to find a list of m-PEG5-succinimidyl carbonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A m-PEG5-succinimidyl carbonate DMF (Drug Master File) is a document detailing the whole manufacturing process of m-PEG5-succinimidyl carbonate active pharmaceutical ingredient (API) in detail. Different forms of m-PEG5-succinimidyl carbonate DMFs exist exist since differing nations have different regulations, such as m-PEG5-succinimidyl carbonate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A m-PEG5-succinimidyl carbonate DMF submitted to regulatory agencies in the US is known as a USDMF. m-PEG5-succinimidyl carbonate USDMF includes data on m-PEG5-succinimidyl carbonate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The m-PEG5-succinimidyl carbonate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of m-PEG5-succinimidyl carbonate suppliers with USDMF on PharmaCompass.
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