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