API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
28
PharmaCompass offers a list of Metaxalone 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 Metaxalone manufacturer or Metaxalone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Metaxalone manufacturer or Metaxalone supplier.
PharmaCompass also assists you with knowing the Metaxalone API Price utilized in the formulation of products. Metaxalone API Price is not always fixed or binding as the Metaxalone Price is obtained through a variety of data sources. The Metaxalone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Metaxalone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Metaxalone, including repackagers and relabelers. The FDA regulates Metaxalone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Metaxalone 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 Metaxalone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Metaxalone supplier is an individual or a company that provides Metaxalone active pharmaceutical ingredient (API) or Metaxalone finished formulations upon request. The Metaxalone suppliers may include Metaxalone API manufacturers, exporters, distributors and traders.
click here to find a list of Metaxalone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Metaxalone DMF (Drug Master File) is a document detailing the whole manufacturing process of Metaxalone active pharmaceutical ingredient (API) in detail. Different forms of Metaxalone DMFs exist exist since differing nations have different regulations, such as Metaxalone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Metaxalone DMF submitted to regulatory agencies in the US is known as a USDMF. Metaxalone USDMF includes data on Metaxalone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Metaxalone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Metaxalone suppliers with USDMF on PharmaCompass.
A Metaxalone written confirmation (Metaxalone WC) is an official document issued by a regulatory agency to a Metaxalone manufacturer, verifying that the manufacturing facility of a Metaxalone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Metaxalone APIs or Metaxalone finished pharmaceutical products to another nation, regulatory agencies frequently require a Metaxalone WC (written confirmation) as part of the regulatory process.
click here to find a list of Metaxalone 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 Metaxalone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Metaxalone 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 Metaxalone 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 Metaxalone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Metaxalone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Metaxalone suppliers with NDC on PharmaCompass.
Metaxalone 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 Metaxalone 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 Metaxalone GMP manufacturer or Metaxalone GMP API supplier for your needs.
A Metaxalone CoA (Certificate of Analysis) is a formal document that attests to Metaxalone's compliance with Metaxalone specifications and serves as a tool for batch-level quality control.
Metaxalone CoA mostly includes findings from lab analyses of a specific batch. For each Metaxalone 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.
Metaxalone may be tested according to a variety of international standards, such as European Pharmacopoeia (Metaxalone EP), Metaxalone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Metaxalone USP).