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