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