US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Meprobamate 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 Meprobamate manufacturer or Meprobamate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Meprobamate manufacturer or Meprobamate supplier.
PharmaCompass also assists you with knowing the Meprobamate API Price utilized in the formulation of products. Meprobamate API Price is not always fixed or binding as the Meprobamate Price is obtained through a variety of data sources. The Meprobamate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Meprobamate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Meprobamate, including repackagers and relabelers. The FDA regulates Meprobamate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Meprobamate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Meprobamate supplier is an individual or a company that provides Meprobamate active pharmaceutical ingredient (API) or Meprobamate finished formulations upon request. The Meprobamate suppliers may include Meprobamate API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Meprobamate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Meprobamate DMF (Drug Master File) is a document detailing the whole manufacturing process of Meprobamate active pharmaceutical ingredient (API) in detail. Different forms of Meprobamate DMFs exist exist since differing nations have different regulations, such as Meprobamate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Meprobamate DMF submitted to regulatory agencies in the US is known as a USDMF. Meprobamate USDMF includes data on Meprobamate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Meprobamate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A Meprobamate CEP of the European Pharmacopoeia monograph is often referred to as a Meprobamate Certificate of Suitability (COS). The purpose of a Meprobamate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Meprobamate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Meprobamate to their clients by showing that a Meprobamate CEP has been issued for it. The manufacturer submits a Meprobamate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Meprobamate CEP holder for the record. Additionally, the data presented in the Meprobamate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Meprobamate DMF.
A Meprobamate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Meprobamate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Meprobamate written confirmation (Meprobamate WC) is an official document issued by a regulatory agency to a Meprobamate manufacturer, verifying that the manufacturing facility of a Meprobamate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Meprobamate APIs or Meprobamate finished pharmaceutical products to another nation, regulatory agencies frequently require a Meprobamate WC (written confirmation) as part of the regulatory process.
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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 Meprobamate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Meprobamate 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 Meprobamate 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 Meprobamate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Meprobamate NDC to their finished compounded human drug products, they may choose to do so.
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Meprobamate 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 Meprobamate 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 Meprobamate GMP manufacturer or Meprobamate GMP API supplier for your needs.
A Meprobamate CoA (Certificate of Analysis) is a formal document that attests to Meprobamate's compliance with Meprobamate specifications and serves as a tool for batch-level quality control.
Meprobamate CoA mostly includes findings from lab analyses of a specific batch. For each Meprobamate 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.
Meprobamate may be tested according to a variety of international standards, such as European Pharmacopoeia (Meprobamate EP), Meprobamate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Meprobamate USP).