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