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