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