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API SUPPLIERS
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Triflusal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Triflusal, including repackagers and relabelers. The FDA regulates Triflusal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Triflusal 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 Triflusal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Triflusal supplier is an individual or a company that provides Triflusal active pharmaceutical ingredient (API) or Triflusal finished formulations upon request. The Triflusal suppliers may include Triflusal API manufacturers, exporters, distributors and traders.
click here to find a list of Triflusal suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Triflusal Drug Master File in Korea (Triflusal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Triflusal. The MFDS reviews the Triflusal KDMF as part of the drug registration process and uses the information provided in the Triflusal KDMF to evaluate the safety and efficacy of the drug.
After submitting a Triflusal 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 Triflusal API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Triflusal suppliers with KDMF on PharmaCompass.
A Triflusal CEP of the European Pharmacopoeia monograph is often referred to as a Triflusal Certificate of Suitability (COS). The purpose of a Triflusal CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Triflusal EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Triflusal to their clients by showing that a Triflusal CEP has been issued for it. The manufacturer submits a Triflusal CEP (COS) as part of the market authorization procedure, and it takes on the role of a Triflusal CEP holder for the record. Additionally, the data presented in the Triflusal CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Triflusal DMF.
A Triflusal CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Triflusal 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 Triflusal suppliers with CEP (COS) on PharmaCompass.
Triflusal 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 Triflusal 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 Triflusal GMP manufacturer or Triflusal GMP API supplier for your needs.
A Triflusal CoA (Certificate of Analysis) is a formal document that attests to Triflusal's compliance with Triflusal specifications and serves as a tool for batch-level quality control.
Triflusal CoA mostly includes findings from lab analyses of a specific batch. For each Triflusal 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.
Triflusal may be tested according to a variety of international standards, such as European Pharmacopoeia (Triflusal EP), Triflusal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Triflusal USP).
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