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