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.
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A Indopol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indopol, including repackagers and relabelers. The FDA regulates Indopol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indopol 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 Indopol supplier is an individual or a company that provides Indopol active pharmaceutical ingredient (API) or Indopol finished formulations upon request. The Indopol suppliers may include Indopol API manufacturers, exporters, distributors and traders.
click here to find a list of Indopol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Indopol DMF (Drug Master File) is a document detailing the whole manufacturing process of Indopol active pharmaceutical ingredient (API) in detail. Different forms of Indopol DMFs exist exist since differing nations have different regulations, such as Indopol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indopol DMF submitted to regulatory agencies in the US is known as a USDMF. Indopol USDMF includes data on Indopol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indopol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indopol suppliers with USDMF on PharmaCompass.
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