Synopsis
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CEP/COS
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JDMF
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KDMF
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VMF
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Canada
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South Africa
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Temad- We think of world-class quality.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
NDC 
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
NDC
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USDMF
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-23
Pay. Date : 2016-04-07
DMF Number : 22992
Submission : 2009-07-28
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Temad- We think of world-class quality.
About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...
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API Imports and Exports
Drugs in Development
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NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Naltrexone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Naltrexone manufacturer or Naltrexone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Naltrexone manufacturer or Naltrexone supplier.
PharmaCompass also assists you with knowing the Naltrexone API Price utilized in the formulation of products. Naltrexone API Price is not always fixed or binding as the Naltrexone Price is obtained through a variety of data sources. The Naltrexone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Naltrexone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naltrexone, including repackagers and relabelers. The FDA regulates Naltrexone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naltrexone 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 Naltrexone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naltrexone supplier is an individual or a company that provides Naltrexone active pharmaceutical ingredient (API) or Naltrexone finished formulations upon request. The Naltrexone suppliers may include Naltrexone API manufacturers, exporters, distributors and traders.
click here to find a list of Naltrexone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Naltrexone DMF (Drug Master File) is a document detailing the whole manufacturing process of Naltrexone active pharmaceutical ingredient (API) in detail. Different forms of Naltrexone DMFs exist exist since differing nations have different regulations, such as Naltrexone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Naltrexone DMF submitted to regulatory agencies in the US is known as a USDMF. Naltrexone USDMF includes data on Naltrexone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naltrexone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Naltrexone suppliers with USDMF on PharmaCompass.
A Naltrexone written confirmation (Naltrexone WC) is an official document issued by a regulatory agency to a Naltrexone manufacturer, verifying that the manufacturing facility of a Naltrexone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naltrexone APIs or Naltrexone finished pharmaceutical products to another nation, regulatory agencies frequently require a Naltrexone WC (written confirmation) as part of the regulatory process.
click here to find a list of Naltrexone suppliers with Written Confirmation (WC) 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 Naltrexone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Naltrexone 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 Naltrexone 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 Naltrexone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naltrexone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Naltrexone suppliers with NDC on PharmaCompass.
Naltrexone 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 Naltrexone 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 Naltrexone GMP manufacturer or Naltrexone GMP API supplier for your needs.
A Naltrexone CoA (Certificate of Analysis) is a formal document that attests to Naltrexone's compliance with Naltrexone specifications and serves as a tool for batch-level quality control.
Naltrexone CoA mostly includes findings from lab analyses of a specific batch. For each Naltrexone 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.
Naltrexone may be tested according to a variety of international standards, such as European Pharmacopoeia (Naltrexone EP), Naltrexone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naltrexone USP).
