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