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Looking for 135046-48-9 / Clopidogrel API manufacturers, exporters & distributors?

Clopidogrel manufacturers, exporters & distributors 1

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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.

API | Excipient name

Clopidogrel

Synonyms

120202-66-6, Clopidogrel sulfate, Clopidogrel hydrogen sulfate, Iscover, Plavix, Clopidogrel bisulphate

Cas Number

135046-48-9

Unique Ingredient Identifier (UNII)

08I79HTP27

About Clopidogrel

A ticlopidine analog and platelet purinergic P2Y receptor antagonist that inhibits adenosine diphosphate-mediated PLATELET AGGREGATION. It is used to prevent THROMBOEMBOLISM in patients with ARTERIAL OCCLUSIVE DISEASES; MYOCARDIAL INFARCTION; STROKE; or ATRIAL FIBRILLATION.

Clopidogrel Hydrogen Sulphate Manufacturers

A Clopidogrel Hydrogen Sulphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clopidogrel Hydrogen Sulphate, including repackagers and relabelers. The FDA regulates Clopidogrel Hydrogen Sulphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clopidogrel Hydrogen 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 Clopidogrel Hydrogen Sulphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Clopidogrel Hydrogen Sulphate Suppliers

A Clopidogrel Hydrogen Sulphate supplier is an individual or a company that provides Clopidogrel Hydrogen Sulphate active pharmaceutical ingredient (API) or Clopidogrel Hydrogen Sulphate finished formulations upon request. The Clopidogrel Hydrogen Sulphate suppliers may include Clopidogrel Hydrogen Sulphate API manufacturers, exporters, distributors and traders.

click here to find a list of Clopidogrel Hydrogen Sulphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Clopidogrel Hydrogen Sulphate USDMF

A Clopidogrel Hydrogen Sulphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Clopidogrel Hydrogen Sulphate active pharmaceutical ingredient (API) in detail. Different forms of Clopidogrel Hydrogen Sulphate DMFs exist exist since differing nations have different regulations, such as Clopidogrel Hydrogen Sulphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Clopidogrel Hydrogen Sulphate DMF submitted to regulatory agencies in the US is known as a USDMF. Clopidogrel Hydrogen Sulphate USDMF includes data on Clopidogrel Hydrogen Sulphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clopidogrel Hydrogen Sulphate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Clopidogrel Hydrogen Sulphate suppliers with USDMF on PharmaCompass.

Clopidogrel Hydrogen Sulphate JDMF

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 Hydrogen Sulphate Drug Master File in Japan (Clopidogrel Hydrogen Sulphate JDMF) empowers Clopidogrel Hydrogen 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 Clopidogrel Hydrogen Sulphate JDMF during the approval evaluation for pharmaceutical products. At the time of Clopidogrel Hydrogen 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 Clopidogrel Hydrogen Sulphate suppliers with JDMF on PharmaCompass.

Clopidogrel Hydrogen Sulphate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Clopidogrel Hydrogen Sulphate Drug Master File in Korea (Clopidogrel Hydrogen Sulphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Clopidogrel Hydrogen Sulphate. The MFDS reviews the Clopidogrel Hydrogen Sulphate KDMF as part of the drug registration process and uses the information provided in the Clopidogrel Hydrogen Sulphate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Clopidogrel Hydrogen 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 Clopidogrel Hydrogen Sulphate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Clopidogrel Hydrogen Sulphate suppliers with KDMF on PharmaCompass.

Clopidogrel Hydrogen Sulphate CEP

A Clopidogrel Hydrogen Sulphate CEP of the European Pharmacopoeia monograph is often referred to as a Clopidogrel Hydrogen Sulphate Certificate of Suitability (COS). The purpose of a Clopidogrel Hydrogen Sulphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Clopidogrel Hydrogen Sulphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Clopidogrel Hydrogen Sulphate to their clients by showing that a Clopidogrel Hydrogen Sulphate CEP has been issued for it. The manufacturer submits a Clopidogrel Hydrogen Sulphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Clopidogrel Hydrogen Sulphate CEP holder for the record. Additionally, the data presented in the Clopidogrel Hydrogen Sulphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Clopidogrel Hydrogen Sulphate DMF.

A Clopidogrel Hydrogen Sulphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Clopidogrel Hydrogen 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 Clopidogrel Hydrogen Sulphate suppliers with CEP (COS) on PharmaCompass.

Clopidogrel Hydrogen Sulphate WC

A Clopidogrel Hydrogen Sulphate written confirmation (Clopidogrel Hydrogen Sulphate WC) is an official document issued by a regulatory agency to a Clopidogrel Hydrogen Sulphate manufacturer, verifying that the manufacturing facility of a Clopidogrel Hydrogen Sulphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Clopidogrel Hydrogen Sulphate APIs or Clopidogrel Hydrogen Sulphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Clopidogrel Hydrogen Sulphate WC (written confirmation) as part of the regulatory process.

click here to find a list of Clopidogrel Hydrogen Sulphate suppliers with Written Confirmation (WC) on PharmaCompass.

Clopidogrel Hydrogen Sulphate NDC

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 Hydrogen Sulphate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Clopidogrel Hydrogen Sulphate API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Hydrogen 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Clopidogrel Hydrogen Sulphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clopidogrel Hydrogen Sulphate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Clopidogrel Hydrogen Sulphate suppliers with NDC on PharmaCompass.

Clopidogrel Hydrogen Sulphate GMP

Clopidogrel Hydrogen 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 Clopidogrel Hydrogen 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 Clopidogrel Hydrogen Sulphate GMP manufacturer or Clopidogrel Hydrogen Sulphate GMP API supplier for your needs.

Clopidogrel Hydrogen Sulphate CoA

A Clopidogrel Hydrogen Sulphate CoA (Certificate of Analysis) is a formal document that attests to Clopidogrel Hydrogen Sulphate's compliance with Clopidogrel Hydrogen Sulphate specifications and serves as a tool for batch-level quality control.

Clopidogrel Hydrogen Sulphate CoA mostly includes findings from lab analyses of a specific batch. For each Clopidogrel Hydrogen 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.

Clopidogrel Hydrogen Sulphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Clopidogrel Hydrogen Sulphate EP), Clopidogrel Hydrogen Sulphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clopidogrel Hydrogen Sulphate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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