Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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API
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FDF
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Europe
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - 1MG/ML
USFDA APPLICATION NUMBER - 11707
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG
USFDA APPLICATION NUMBER - 201655
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG
USFDA APPLICATION NUMBER - 201655
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MG
USFDA APPLICATION NUMBER - 201655
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG
USFDA APPLICATION NUMBER - 201655
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 40MG
USFDA APPLICATION NUMBER - 201655
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG
USFDA APPLICATION NUMBER - 201655
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 7.5M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 7.5MG
USFDA APPLICATION NUMBER - 201655
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21610
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21610
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21610
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21610
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 40MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21610
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG ...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21610
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 7.5M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21610
DOSAGE - TABLET;ORAL - 10MG **Federal Registe...DOSAGE - TABLET;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21611
DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21611
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Oxymorphone HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxymorphone HCl, including repackagers and relabelers. The FDA regulates Oxymorphone HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxymorphone HCl 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 HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxymorphone HCl supplier is an individual or a company that provides Oxymorphone HCl active pharmaceutical ingredient (API) or Oxymorphone HCl finished formulations upon request. The Oxymorphone HCl suppliers may include Oxymorphone HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Oxymorphone HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxymorphone HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxymorphone HCl active pharmaceutical ingredient (API) in detail. Different forms of Oxymorphone HCl DMFs exist exist since differing nations have different regulations, such as Oxymorphone HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxymorphone HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Oxymorphone HCl USDMF includes data on Oxymorphone HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxymorphone HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxymorphone HCl suppliers with USDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Oxymorphone HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oxymorphone HCl API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Oxymorphone HCl as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Oxymorphone HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxymorphone HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oxymorphone HCl suppliers with NDC on PharmaCompass.
Oxymorphone HCl Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Oxymorphone HCl GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Oxymorphone HCl GMP manufacturer or Oxymorphone HCl GMP API supplier for your needs.
A Oxymorphone HCl CoA (Certificate of Analysis) is a formal document that attests to Oxymorphone HCl's compliance with Oxymorphone HCl specifications and serves as a tool for batch-level quality control.
Oxymorphone HCl CoA mostly includes findings from lab analyses of a specific batch. For each Oxymorphone HCl CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Oxymorphone HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxymorphone HCl EP), Oxymorphone HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxymorphone HCl USP).
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