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ABOUT THIS PAGE
15
PharmaCompass offers a list of Safinamide Mesylate 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 Safinamide Mesylate manufacturer or Safinamide Mesylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Safinamide Mesylate manufacturer or Safinamide Mesylate supplier.
PharmaCompass also assists you with knowing the Safinamide Mesylate API Price utilized in the formulation of products. Safinamide Mesylate API Price is not always fixed or binding as the Safinamide Mesylate Price is obtained through a variety of data sources. The Safinamide Mesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Safinamide Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Safinamide Mesylate, including repackagers and relabelers. The FDA regulates Safinamide Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Safinamide Mesylate 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 Safinamide Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Safinamide Mesylate supplier is an individual or a company that provides Safinamide Mesylate active pharmaceutical ingredient (API) or Safinamide Mesylate finished formulations upon request. The Safinamide Mesylate suppliers may include Safinamide Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Safinamide Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Safinamide Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Safinamide Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Safinamide Mesylate DMFs exist exist since differing nations have different regulations, such as Safinamide Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Safinamide Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Safinamide Mesylate USDMF includes data on Safinamide Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Safinamide Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Safinamide Mesylate 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 Safinamide Mesylate Drug Master File in Japan (Safinamide Mesylate JDMF) empowers Safinamide Mesylate 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 Safinamide Mesylate JDMF during the approval evaluation for pharmaceutical products. At the time of Safinamide Mesylate 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 Safinamide Mesylate 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 Safinamide Mesylate Drug Master File in Korea (Safinamide Mesylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Safinamide Mesylate. The MFDS reviews the Safinamide Mesylate KDMF as part of the drug registration process and uses the information provided in the Safinamide Mesylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Safinamide Mesylate 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 Safinamide Mesylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Safinamide Mesylate suppliers with KDMF on PharmaCompass.
A Safinamide Mesylate written confirmation (Safinamide Mesylate WC) is an official document issued by a regulatory agency to a Safinamide Mesylate manufacturer, verifying that the manufacturing facility of a Safinamide Mesylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Safinamide Mesylate APIs or Safinamide Mesylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Safinamide Mesylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Safinamide Mesylate 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 Safinamide Mesylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Safinamide Mesylate 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 Safinamide Mesylate 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 Safinamide Mesylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Safinamide Mesylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Safinamide Mesylate suppliers with NDC on PharmaCompass.
Safinamide Mesylate 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 Safinamide Mesylate 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 Safinamide Mesylate GMP manufacturer or Safinamide Mesylate GMP API supplier for your needs.
A Safinamide Mesylate CoA (Certificate of Analysis) is a formal document that attests to Safinamide Mesylate's compliance with Safinamide Mesylate specifications and serves as a tool for batch-level quality control.
Safinamide Mesylate CoA mostly includes findings from lab analyses of a specific batch. For each Safinamide Mesylate 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.
Safinamide Mesylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Safinamide Mesylate EP), Safinamide Mesylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Safinamide Mesylate USP).
