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