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API SUPPLIERS
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USDMF
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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the c...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...
Suanfarma, at the Core of a Better Life.
About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indu...
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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Drugs in Development
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DOSAGE - TABLET;ORAL - EQ 100MG BASE
USFDA APPLICATION NUMBER - 207145
DOSAGE - TABLET;ORAL - EQ 50MG BASE
USFDA APPLICATION NUMBER - 207145
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ABOUT THIS PAGE
A Safinamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Safinamide, including repackagers and relabelers. The FDA regulates Safinamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Safinamide 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Safinamide supplier is an individual or a company that provides Safinamide active pharmaceutical ingredient (API) or Safinamide finished formulations upon request. The Safinamide suppliers may include Safinamide API manufacturers, exporters, distributors and traders.
click here to find a list of Safinamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Safinamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Safinamide active pharmaceutical ingredient (API) in detail. Different forms of Safinamide DMFs exist exist since differing nations have different regulations, such as Safinamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Safinamide DMF submitted to regulatory agencies in the US is known as a USDMF. Safinamide USDMF includes data on Safinamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Safinamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Safinamide 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 Drug Master File in Japan (Safinamide JDMF) empowers Safinamide 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Safinamide 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 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 Drug Master File in Korea (Safinamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Safinamide. The MFDS reviews the Safinamide KDMF as part of the drug registration process and uses the information provided in the Safinamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Safinamide 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Safinamide suppliers with KDMF on PharmaCompass.
A Safinamide written confirmation (Safinamide WC) is an official document issued by a regulatory agency to a Safinamide manufacturer, verifying that the manufacturing facility of a Safinamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Safinamide APIs or Safinamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Safinamide WC (written confirmation) as part of the regulatory process.
click here to find a list of Safinamide 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Safinamide 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Safinamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Safinamide suppliers with NDC on PharmaCompass.
Safinamide 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 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 GMP manufacturer or Safinamide GMP API supplier for your needs.
A Safinamide CoA (Certificate of Analysis) is a formal document that attests to Safinamide's compliance with Safinamide specifications and serves as a tool for batch-level quality control.
Safinamide CoA mostly includes findings from lab analyses of a specific batch. For each Safinamide 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Safinamide EP), Safinamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Safinamide USP).
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