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JDMF
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Australia
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Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
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API Imports and Exports
Drugs in Development
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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 90MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG
USFDA APPLICATION NUMBER - 200063
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 80M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
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Fillers, Diluents & Binders
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Emulsifying Agents
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Chewable & Orodispersible Aids
Digital Content
NEWS #PharmaBuzz
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Naltrexone Hydrochloride 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 Hydrochloride manufacturer or Naltrexone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Naltrexone Hydrochloride manufacturer or Naltrexone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Naltrexone Hydrochloride API Price utilized in the formulation of products. Naltrexone Hydrochloride API Price is not always fixed or binding as the Naltrexone Hydrochloride Price is obtained through a variety of data sources. The Naltrexone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Antaxone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Antaxone, including repackagers and relabelers. The FDA regulates Antaxone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Antaxone 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 Antaxone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Antaxone supplier is an individual or a company that provides Antaxone active pharmaceutical ingredient (API) or Antaxone finished formulations upon request. The Antaxone suppliers may include Antaxone API manufacturers, exporters, distributors and traders.
click here to find a list of Antaxone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Antaxone DMF (Drug Master File) is a document detailing the whole manufacturing process of Antaxone active pharmaceutical ingredient (API) in detail. Different forms of Antaxone DMFs exist exist since differing nations have different regulations, such as Antaxone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Antaxone DMF submitted to regulatory agencies in the US is known as a USDMF. Antaxone USDMF includes data on Antaxone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Antaxone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Antaxone suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Antaxone Drug Master File in Korea (Antaxone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Antaxone. The MFDS reviews the Antaxone KDMF as part of the drug registration process and uses the information provided in the Antaxone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Antaxone KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Antaxone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Antaxone suppliers with KDMF on PharmaCompass.
A Antaxone CEP of the European Pharmacopoeia monograph is often referred to as a Antaxone Certificate of Suitability (COS). The purpose of a Antaxone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Antaxone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Antaxone to their clients by showing that a Antaxone CEP has been issued for it. The manufacturer submits a Antaxone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Antaxone CEP holder for the record. Additionally, the data presented in the Antaxone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Antaxone DMF.
A Antaxone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Antaxone CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Antaxone suppliers with CEP (COS) on PharmaCompass.
A Antaxone written confirmation (Antaxone WC) is an official document issued by a regulatory agency to a Antaxone manufacturer, verifying that the manufacturing facility of a Antaxone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Antaxone APIs or Antaxone finished pharmaceutical products to another nation, regulatory agencies frequently require a Antaxone WC (written confirmation) as part of the regulatory process.
click here to find a list of Antaxone 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 Antaxone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Antaxone 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 Antaxone 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 Antaxone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Antaxone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Antaxone suppliers with NDC on PharmaCompass.
Antaxone 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 Antaxone 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 Antaxone GMP manufacturer or Antaxone GMP API supplier for your needs.
A Antaxone CoA (Certificate of Analysis) is a formal document that attests to Antaxone's compliance with Antaxone specifications and serves as a tool for batch-level quality control.
Antaxone CoA mostly includes findings from lab analyses of a specific batch. For each Antaxone 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.
Antaxone may be tested according to a variety of international standards, such as European Pharmacopoeia (Antaxone EP), Antaxone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Antaxone USP).
