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