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