API Suppliers
US DMFs Filed
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CEP/COS Certifications
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JDMFs Filed
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EU WC
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Listed Suppliers
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USA (Orange Book)
Europe
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Canada
Australia
South Africa
Uploaded Dossiers
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U.S. Medicaid
Annual Reports
25
PharmaCompass offers a list of Brigatinib 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 Brigatinib manufacturer or Brigatinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Brigatinib manufacturer or Brigatinib supplier.
PharmaCompass also assists you with knowing the Brigatinib API Price utilized in the formulation of products. Brigatinib API Price is not always fixed or binding as the Brigatinib Price is obtained through a variety of data sources. The Brigatinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Brigatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brigatinib, including repackagers and relabelers. The FDA regulates Brigatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brigatinib 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 Brigatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Brigatinib supplier is an individual or a company that provides Brigatinib active pharmaceutical ingredient (API) or Brigatinib finished formulations upon request. The Brigatinib suppliers may include Brigatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Brigatinib 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 Brigatinib Drug Master File in Korea (Brigatinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Brigatinib. The MFDS reviews the Brigatinib KDMF as part of the drug registration process and uses the information provided in the Brigatinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Brigatinib 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 Brigatinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Brigatinib 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 Brigatinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Brigatinib 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 Brigatinib 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 Brigatinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Brigatinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Brigatinib suppliers with NDC on PharmaCompass.
Brigatinib 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 Brigatinib 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 Brigatinib GMP manufacturer or Brigatinib GMP API supplier for your needs.
A Brigatinib CoA (Certificate of Analysis) is a formal document that attests to Brigatinib's compliance with Brigatinib specifications and serves as a tool for batch-level quality control.
Brigatinib CoA mostly includes findings from lab analyses of a specific batch. For each Brigatinib 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.
Brigatinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Brigatinib EP), Brigatinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Brigatinib USP).