X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
11
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 Onfi manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Onfi, including repackagers and relabelers. The FDA regulates Onfi manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Onfi 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 Onfi manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Onfi supplier is an individual or a company that provides Onfi active pharmaceutical ingredient (API) or Onfi finished formulations upon request. The Onfi suppliers may include Onfi API manufacturers, exporters, distributors and traders.
click here to find a list of Onfi suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Onfi DMF (Drug Master File) is a document detailing the whole manufacturing process of Onfi active pharmaceutical ingredient (API) in detail. Different forms of Onfi DMFs exist exist since differing nations have different regulations, such as Onfi USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Onfi DMF submitted to regulatory agencies in the US is known as a USDMF. Onfi USDMF includes data on Onfi's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Onfi USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Onfi 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 Onfi Drug Master File in Japan (Onfi JDMF) empowers Onfi 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 Onfi JDMF during the approval evaluation for pharmaceutical products. At the time of Onfi 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 Onfi suppliers with JDMF on PharmaCompass.
A Onfi CEP of the European Pharmacopoeia monograph is often referred to as a Onfi Certificate of Suitability (COS). The purpose of a Onfi CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Onfi EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Onfi to their clients by showing that a Onfi CEP has been issued for it. The manufacturer submits a Onfi CEP (COS) as part of the market authorization procedure, and it takes on the role of a Onfi CEP holder for the record. Additionally, the data presented in the Onfi CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Onfi DMF.
A Onfi CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Onfi 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 Onfi suppliers with CEP (COS) on PharmaCompass.
A Onfi written confirmation (Onfi WC) is an official document issued by a regulatory agency to a Onfi manufacturer, verifying that the manufacturing facility of a Onfi active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Onfi APIs or Onfi finished pharmaceutical products to another nation, regulatory agencies frequently require a Onfi WC (written confirmation) as part of the regulatory process.
click here to find a list of Onfi 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 Onfi as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Onfi 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 Onfi 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 Onfi and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Onfi NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Onfi suppliers with NDC on PharmaCompass.
Onfi 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 Onfi 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 Onfi GMP manufacturer or Onfi GMP API supplier for your needs.
A Onfi CoA (Certificate of Analysis) is a formal document that attests to Onfi's compliance with Onfi specifications and serves as a tool for batch-level quality control.
Onfi CoA mostly includes findings from lab analyses of a specific batch. For each Onfi 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.
Onfi may be tested according to a variety of international standards, such as European Pharmacopoeia (Onfi EP), Onfi JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Onfi USP).
Market Place
