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