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01 1G3139 ACTIVE PHARMACEUTICAL INGREDIENT
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01 1Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14931
Submission : 2000-06-15
Status : Inactive
Type : II
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A Oblimersen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oblimersen, including repackagers and relabelers. The FDA regulates Oblimersen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oblimersen 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 Oblimersen supplier is an individual or a company that provides Oblimersen active pharmaceutical ingredient (API) or Oblimersen finished formulations upon request. The Oblimersen suppliers may include Oblimersen API manufacturers, exporters, distributors and traders.
click here to find a list of Oblimersen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oblimersen DMF (Drug Master File) is a document detailing the whole manufacturing process of Oblimersen active pharmaceutical ingredient (API) in detail. Different forms of Oblimersen DMFs exist exist since differing nations have different regulations, such as Oblimersen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oblimersen DMF submitted to regulatory agencies in the US is known as a USDMF. Oblimersen USDMF includes data on Oblimersen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oblimersen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oblimersen suppliers with USDMF on PharmaCompass.
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