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JDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
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- CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Related Excipient Companies
Evonik
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Coating Systems & Additives
Fillers, Diluents & Binders
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Co-Processed Excipients
Empty Capsules
Rheology Modifiers
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Surfactant & Foaming Agents
Chewable & Orodispersible Aids
Digital Content
NEWS #PharmaBuzz
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US Medicaid Prescriptions
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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 Vivitrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vivitrol, including repackagers and relabelers. The FDA regulates Vivitrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vivitrol 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 Vivitrol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vivitrol supplier is an individual or a company that provides Vivitrol active pharmaceutical ingredient (API) or Vivitrol finished formulations upon request. The Vivitrol suppliers may include Vivitrol API manufacturers, exporters, distributors and traders.
click here to find a list of Vivitrol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vivitrol DMF (Drug Master File) is a document detailing the whole manufacturing process of Vivitrol active pharmaceutical ingredient (API) in detail. Different forms of Vivitrol DMFs exist exist since differing nations have different regulations, such as Vivitrol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vivitrol DMF submitted to regulatory agencies in the US is known as a USDMF. Vivitrol USDMF includes data on Vivitrol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vivitrol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vivitrol 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 Vivitrol Drug Master File in Korea (Vivitrol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vivitrol. The MFDS reviews the Vivitrol KDMF as part of the drug registration process and uses the information provided in the Vivitrol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vivitrol 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 Vivitrol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vivitrol suppliers with KDMF on PharmaCompass.
A Vivitrol CEP of the European Pharmacopoeia monograph is often referred to as a Vivitrol Certificate of Suitability (COS). The purpose of a Vivitrol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vivitrol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vivitrol to their clients by showing that a Vivitrol CEP has been issued for it. The manufacturer submits a Vivitrol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vivitrol CEP holder for the record. Additionally, the data presented in the Vivitrol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vivitrol DMF.
A Vivitrol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vivitrol 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 Vivitrol suppliers with CEP (COS) on PharmaCompass.
A Vivitrol written confirmation (Vivitrol WC) is an official document issued by a regulatory agency to a Vivitrol manufacturer, verifying that the manufacturing facility of a Vivitrol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vivitrol APIs or Vivitrol finished pharmaceutical products to another nation, regulatory agencies frequently require a Vivitrol WC (written confirmation) as part of the regulatory process.
click here to find a list of Vivitrol 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 Vivitrol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vivitrol 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 Vivitrol 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 Vivitrol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vivitrol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vivitrol suppliers with NDC on PharmaCompass.
Vivitrol 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 Vivitrol 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 Vivitrol GMP manufacturer or Vivitrol GMP API supplier for your needs.
A Vivitrol CoA (Certificate of Analysis) is a formal document that attests to Vivitrol's compliance with Vivitrol specifications and serves as a tool for batch-level quality control.
Vivitrol CoA mostly includes findings from lab analyses of a specific batch. For each Vivitrol 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.
Vivitrol may be tested according to a variety of international standards, such as European Pharmacopoeia (Vivitrol EP), Vivitrol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vivitrol USP).
