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PharmaCompass offers a list of Nabumetone 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 Nabumetone manufacturer or Nabumetone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nabumetone manufacturer or Nabumetone supplier.
PharmaCompass also assists you with knowing the Nabumetone API Price utilized in the formulation of products. Nabumetone API Price is not always fixed or binding as the Nabumetone Price is obtained through a variety of data sources. The Nabumetone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nabumetone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nabumetone, including repackagers and relabelers. The FDA regulates Nabumetone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nabumetone 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 Nabumetone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nabumetone supplier is an individual or a company that provides Nabumetone active pharmaceutical ingredient (API) or Nabumetone finished formulations upon request. The Nabumetone suppliers may include Nabumetone API manufacturers, exporters, distributors and traders.
click here to find a list of Nabumetone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nabumetone DMF (Drug Master File) is a document detailing the whole manufacturing process of Nabumetone active pharmaceutical ingredient (API) in detail. Different forms of Nabumetone DMFs exist exist since differing nations have different regulations, such as Nabumetone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nabumetone DMF submitted to regulatory agencies in the US is known as a USDMF. Nabumetone USDMF includes data on Nabumetone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nabumetone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nabumetone suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Nabumetone Drug Master File in Japan (Nabumetone JDMF) empowers Nabumetone API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Nabumetone JDMF during the approval evaluation for pharmaceutical products. At the time of Nabumetone JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Nabumetone suppliers with JDMF 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 Nabumetone Drug Master File in Korea (Nabumetone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nabumetone. The MFDS reviews the Nabumetone KDMF as part of the drug registration process and uses the information provided in the Nabumetone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nabumetone 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 Nabumetone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nabumetone suppliers with KDMF on PharmaCompass.
A Nabumetone CEP of the European Pharmacopoeia monograph is often referred to as a Nabumetone Certificate of Suitability (COS). The purpose of a Nabumetone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nabumetone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nabumetone to their clients by showing that a Nabumetone CEP has been issued for it. The manufacturer submits a Nabumetone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nabumetone CEP holder for the record. Additionally, the data presented in the Nabumetone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nabumetone DMF.
A Nabumetone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nabumetone 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 Nabumetone suppliers with CEP (COS) on PharmaCompass.
A Nabumetone written confirmation (Nabumetone WC) is an official document issued by a regulatory agency to a Nabumetone manufacturer, verifying that the manufacturing facility of a Nabumetone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nabumetone APIs or Nabumetone finished pharmaceutical products to another nation, regulatory agencies frequently require a Nabumetone WC (written confirmation) as part of the regulatory process.
click here to find a list of Nabumetone 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 Nabumetone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nabumetone 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 Nabumetone 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 Nabumetone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nabumetone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nabumetone suppliers with NDC on PharmaCompass.
Nabumetone 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 Nabumetone 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 Nabumetone GMP manufacturer or Nabumetone GMP API supplier for your needs.
A Nabumetone CoA (Certificate of Analysis) is a formal document that attests to Nabumetone's compliance with Nabumetone specifications and serves as a tool for batch-level quality control.
Nabumetone CoA mostly includes findings from lab analyses of a specific batch. For each Nabumetone 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.
Nabumetone may be tested according to a variety of international standards, such as European Pharmacopoeia (Nabumetone EP), Nabumetone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nabumetone USP).
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