01 1Mallinckrodt Pharmaceuticals
01 1OXYMORPHONE BASE
01 1Ireland
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21372
Submission : 2008-02-18
Status : Active
Type : II
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PharmaCompass offers a list of Oxymorphone 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 Oxymorphone manufacturer or Oxymorphone supplier for your needs.
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A Oxymorphone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxymorphone, including repackagers and relabelers. The FDA regulates Oxymorphone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxymorphone 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 Oxymorphone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Oxymorphone supplier is an individual or a company that provides Oxymorphone active pharmaceutical ingredient (API) or Oxymorphone finished formulations upon request. The Oxymorphone suppliers may include Oxymorphone API manufacturers, exporters, distributors and traders.
click here to find a list of Oxymorphone suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Oxymorphone DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxymorphone active pharmaceutical ingredient (API) in detail. Different forms of Oxymorphone DMFs exist exist since differing nations have different regulations, such as Oxymorphone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxymorphone DMF submitted to regulatory agencies in the US is known as a USDMF. Oxymorphone USDMF includes data on Oxymorphone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxymorphone USDMF is kept confidential to protect the manufacturer’s intellectual property.
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