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