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