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