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