01 1Ineos Oligomers
01 1INDOPOL(R) POLYBUTENE PRODUCTS
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17390
Submission : 2004-05-18
Status : Active
Type : IV
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PharmaCompass offers a list of Polybutene 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 Polybutene manufacturer or Polybutene supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Polybutene manufacturer or Polybutene supplier.
A Polybutene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polybutene, including repackagers and relabelers. The FDA regulates Polybutene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polybutene 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 Polybutene supplier is an individual or a company that provides Polybutene active pharmaceutical ingredient (API) or Polybutene finished formulations upon request. The Polybutene suppliers may include Polybutene API manufacturers, exporters, distributors and traders.
click here to find a list of Polybutene suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Polybutene DMF (Drug Master File) is a document detailing the whole manufacturing process of Polybutene active pharmaceutical ingredient (API) in detail. Different forms of Polybutene DMFs exist exist since differing nations have different regulations, such as Polybutene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polybutene DMF submitted to regulatory agencies in the US is known as a USDMF. Polybutene USDMF includes data on Polybutene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polybutene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polybutene suppliers with USDMF on PharmaCompass.
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