01 1NEKTAR AL
01 1METHOXYPOLY (ETHYLENE GLYCOL)- SUCCINIMIDYL BUTANOATE, MW 30,000 (MSBA30K)
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18674
Submission : 2001-08-06
Status : Inactive
Type : II
A Mts-Peg5000 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mts-Peg5000, including repackagers and relabelers. The FDA regulates Mts-Peg5000 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mts-Peg5000 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 Mts-Peg5000 supplier is an individual or a company that provides Mts-Peg5000 active pharmaceutical ingredient (API) or Mts-Peg5000 finished formulations upon request. The Mts-Peg5000 suppliers may include Mts-Peg5000 API manufacturers, exporters, distributors and traders.
click here to find a list of Mts-Peg5000 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mts-Peg5000 DMF (Drug Master File) is a document detailing the whole manufacturing process of Mts-Peg5000 active pharmaceutical ingredient (API) in detail. Different forms of Mts-Peg5000 DMFs exist exist since differing nations have different regulations, such as Mts-Peg5000 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mts-Peg5000 DMF submitted to regulatory agencies in the US is known as a USDMF. Mts-Peg5000 USDMF includes data on Mts-Peg5000's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mts-Peg5000 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mts-Peg5000 suppliers with USDMF on PharmaCompass.
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