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PharmaCompass offers a list of Terfenadine 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 Terfenadine manufacturer or Terfenadine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Terfenadine manufacturer or Terfenadine supplier.
PharmaCompass also assists you with knowing the Terfenadine API Price utilized in the formulation of products. Terfenadine API Price is not always fixed or binding as the Terfenadine Price is obtained through a variety of data sources. The Terfenadine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Terfenadine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Terfenadine, including repackagers and relabelers. The FDA regulates Terfenadine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Terfenadine 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 Terfenadine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Terfenadine supplier is an individual or a company that provides Terfenadine active pharmaceutical ingredient (API) or Terfenadine finished formulations upon request. The Terfenadine suppliers may include Terfenadine API manufacturers, exporters, distributors and traders.
click here to find a list of Terfenadine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Terfenadine DMF (Drug Master File) is a document detailing the whole manufacturing process of Terfenadine active pharmaceutical ingredient (API) in detail. Different forms of Terfenadine DMFs exist exist since differing nations have different regulations, such as Terfenadine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Terfenadine DMF submitted to regulatory agencies in the US is known as a USDMF. Terfenadine USDMF includes data on Terfenadine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Terfenadine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Terfenadine suppliers with USDMF on PharmaCompass.
A Terfenadine CEP of the European Pharmacopoeia monograph is often referred to as a Terfenadine Certificate of Suitability (COS). The purpose of a Terfenadine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Terfenadine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Terfenadine to their clients by showing that a Terfenadine CEP has been issued for it. The manufacturer submits a Terfenadine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Terfenadine CEP holder for the record. Additionally, the data presented in the Terfenadine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Terfenadine DMF.
A Terfenadine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Terfenadine 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 Terfenadine suppliers with CEP (COS) on PharmaCompass.
Terfenadine 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 Terfenadine 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 Terfenadine GMP manufacturer or Terfenadine GMP API supplier for your needs.
A Terfenadine CoA (Certificate of Analysis) is a formal document that attests to Terfenadine's compliance with Terfenadine specifications and serves as a tool for batch-level quality control.
Terfenadine CoA mostly includes findings from lab analyses of a specific batch. For each Terfenadine 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.
Terfenadine may be tested according to a variety of international standards, such as European Pharmacopoeia (Terfenadine EP), Terfenadine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Terfenadine USP).