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