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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24995
Submission : 2011-05-25
Status : Active
Type : II
A Isoprene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoprene, including repackagers and relabelers. The FDA regulates Isoprene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoprene API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Isoprene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isoprene supplier is an individual or a company that provides Isoprene active pharmaceutical ingredient (API) or Isoprene finished formulations upon request. The Isoprene suppliers may include Isoprene API manufacturers, exporters, distributors and traders.
click here to find a list of Isoprene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isoprene DMF (Drug Master File) is a document detailing the whole manufacturing process of Isoprene active pharmaceutical ingredient (API) in detail. Different forms of Isoprene DMFs exist exist since differing nations have different regulations, such as Isoprene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isoprene DMF submitted to regulatory agencies in the US is known as a USDMF. Isoprene USDMF includes data on Isoprene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isoprene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isoprene suppliers with USDMF on PharmaCompass.
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