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PharmaCompass offers a list of Filgotinib 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 Filgotinib manufacturer or Filgotinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Filgotinib manufacturer or Filgotinib supplier.
PharmaCompass also assists you with knowing the Filgotinib API Price utilized in the formulation of products. Filgotinib API Price is not always fixed or binding as the Filgotinib Price is obtained through a variety of data sources. The Filgotinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Filgotinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Filgotinib, including repackagers and relabelers. The FDA regulates Filgotinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Filgotinib 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 Filgotinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Filgotinib supplier is an individual or a company that provides Filgotinib active pharmaceutical ingredient (API) or Filgotinib finished formulations upon request. The Filgotinib suppliers may include Filgotinib API manufacturers, exporters, distributors and traders.
click here to find a list of Filgotinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Filgotinib Drug Master File in Korea (Filgotinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Filgotinib. The MFDS reviews the Filgotinib KDMF as part of the drug registration process and uses the information provided in the Filgotinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Filgotinib 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 Filgotinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Filgotinib suppliers with KDMF 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 Filgotinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Filgotinib 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 Filgotinib 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 Filgotinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Filgotinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Filgotinib suppliers with NDC on PharmaCompass.
Filgotinib 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 Filgotinib 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 Filgotinib GMP manufacturer or Filgotinib GMP API supplier for your needs.
A Filgotinib CoA (Certificate of Analysis) is a formal document that attests to Filgotinib's compliance with Filgotinib specifications and serves as a tool for batch-level quality control.
Filgotinib CoA mostly includes findings from lab analyses of a specific batch. For each Filgotinib 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.
Filgotinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Filgotinib EP), Filgotinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Filgotinib USP).
