Synopsis
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JDMF
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VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Temad- We think of world-class quality.
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.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
CEP/COS 
KDMF
CN
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Aspen API. More than just an API™
Product Not Available For Sales
NDC
Jai Radhe Sales is your partner for all your sourcing needs.
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
EU-WC
NDC
KDMF
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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- CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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]Ingredion Pharma Solutions
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
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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
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Fillers, Diluents & Binders
Controlled & Modified Release
Thickeners and Stabilizers
Granulation
Solubilizers
Direct Compression
Lubricants & Glidants
Co-Processed Excipients
Disintegrants & Superdisintegrants
Topical
Film Formers & Plasticizers
Taste Masking
Parenteral
Empty Capsules
Emulsifying Agents
Rheology Modifiers
API Stability Enhancers
Coloring Agents
Surfactant & Foaming Agents
Vegetarian Capsules
Chewable & Orodispersible Aids
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
11
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 ReVia manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ReVia, including repackagers and relabelers. The FDA regulates ReVia manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ReVia 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 ReVia manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ReVia supplier is an individual or a company that provides ReVia active pharmaceutical ingredient (API) or ReVia finished formulations upon request. The ReVia suppliers may include ReVia API manufacturers, exporters, distributors and traders.
click here to find a list of ReVia suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ReVia DMF (Drug Master File) is a document detailing the whole manufacturing process of ReVia active pharmaceutical ingredient (API) in detail. Different forms of ReVia DMFs exist exist since differing nations have different regulations, such as ReVia USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ReVia DMF submitted to regulatory agencies in the US is known as a USDMF. ReVia USDMF includes data on ReVia's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ReVia USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ReVia 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 ReVia Drug Master File in Korea (ReVia KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ReVia. The MFDS reviews the ReVia KDMF as part of the drug registration process and uses the information provided in the ReVia KDMF to evaluate the safety and efficacy of the drug.
After submitting a ReVia 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 ReVia API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ReVia suppliers with KDMF on PharmaCompass.
A ReVia CEP of the European Pharmacopoeia monograph is often referred to as a ReVia Certificate of Suitability (COS). The purpose of a ReVia CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ReVia EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ReVia to their clients by showing that a ReVia CEP has been issued for it. The manufacturer submits a ReVia CEP (COS) as part of the market authorization procedure, and it takes on the role of a ReVia CEP holder for the record. Additionally, the data presented in the ReVia CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ReVia DMF.
A ReVia CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ReVia 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 ReVia suppliers with CEP (COS) on PharmaCompass.
A ReVia written confirmation (ReVia WC) is an official document issued by a regulatory agency to a ReVia manufacturer, verifying that the manufacturing facility of a ReVia active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ReVia APIs or ReVia finished pharmaceutical products to another nation, regulatory agencies frequently require a ReVia WC (written confirmation) as part of the regulatory process.
click here to find a list of ReVia 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 ReVia as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ReVia 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 ReVia 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 ReVia and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ReVia NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ReVia suppliers with NDC on PharmaCompass.
ReVia 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 ReVia 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 ReVia GMP manufacturer or ReVia GMP API supplier for your needs.
A ReVia CoA (Certificate of Analysis) is a formal document that attests to ReVia's compliance with ReVia specifications and serves as a tool for batch-level quality control.
ReVia CoA mostly includes findings from lab analyses of a specific batch. For each ReVia 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.
ReVia may be tested according to a variety of international standards, such as European Pharmacopoeia (ReVia EP), ReVia JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ReVia USP).
