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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 Naltrexone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naltrexone Hydrochloride, including repackagers and relabelers. The FDA regulates Naltrexone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naltrexone Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naltrexone Hydrochloride supplier is an individual or a company that provides Naltrexone Hydrochloride active pharmaceutical ingredient (API) or Naltrexone Hydrochloride finished formulations upon request. The Naltrexone Hydrochloride suppliers may include Naltrexone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Naltrexone Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Naltrexone Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Naltrexone Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Naltrexone Hydrochloride DMFs exist exist since differing nations have different regulations, such as Naltrexone Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Naltrexone Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Naltrexone Hydrochloride USDMF includes data on Naltrexone Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naltrexone Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Naltrexone Hydrochloride 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 Naltrexone Hydrochloride Drug Master File in Korea (Naltrexone Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naltrexone Hydrochloride. The MFDS reviews the Naltrexone Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Naltrexone Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Naltrexone Hydrochloride 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 Naltrexone Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Naltrexone Hydrochloride suppliers with KDMF on PharmaCompass.
A Naltrexone Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Naltrexone Hydrochloride Certificate of Suitability (COS). The purpose of a Naltrexone Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Naltrexone Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Naltrexone Hydrochloride to their clients by showing that a Naltrexone Hydrochloride CEP has been issued for it. The manufacturer submits a Naltrexone Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Naltrexone Hydrochloride CEP holder for the record. Additionally, the data presented in the Naltrexone Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Naltrexone Hydrochloride DMF.
A Naltrexone Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Naltrexone Hydrochloride 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 Naltrexone Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Naltrexone Hydrochloride written confirmation (Naltrexone Hydrochloride WC) is an official document issued by a regulatory agency to a Naltrexone Hydrochloride manufacturer, verifying that the manufacturing facility of a Naltrexone Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naltrexone Hydrochloride APIs or Naltrexone Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Naltrexone Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Naltrexone Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Naltrexone Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naltrexone Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Naltrexone Hydrochloride suppliers with NDC on PharmaCompass.
Naltrexone Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Naltrexone Hydrochloride GMP API supplier for your needs.
A Naltrexone Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Naltrexone Hydrochloride's compliance with Naltrexone Hydrochloride specifications and serves as a tool for batch-level quality control.
Naltrexone Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Naltrexone Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Naltrexone Hydrochloride EP), Naltrexone Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naltrexone Hydrochloride USP).
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