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