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