Synopsis
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USDMF
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JDMF
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EU WC
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KDMF
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NDC API
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FDA Orange Book
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Europe
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Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Tilidine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tilidine, including repackagers and relabelers. The FDA regulates Tilidine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tilidine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Tilidine supplier is an individual or a company that provides Tilidine active pharmaceutical ingredient (API) or Tilidine finished formulations upon request. The Tilidine suppliers may include Tilidine API manufacturers, exporters, distributors and traders.
click here to find a list of Tilidine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tilidine CEP of the European Pharmacopoeia monograph is often referred to as a Tilidine Certificate of Suitability (COS). The purpose of a Tilidine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tilidine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tilidine to their clients by showing that a Tilidine CEP has been issued for it. The manufacturer submits a Tilidine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tilidine CEP holder for the record. Additionally, the data presented in the Tilidine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tilidine DMF.
A Tilidine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tilidine 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 Tilidine suppliers with CEP (COS) on PharmaCompass.
Tilidine 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 Tilidine 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 Tilidine GMP manufacturer or Tilidine GMP API supplier for your needs.
A Tilidine CoA (Certificate of Analysis) is a formal document that attests to Tilidine's compliance with Tilidine specifications and serves as a tool for batch-level quality control.
Tilidine CoA mostly includes findings from lab analyses of a specific batch. For each Tilidine 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.
Tilidine may be tested according to a variety of international standards, such as European Pharmacopoeia (Tilidine EP), Tilidine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tilidine USP).
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