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PharmaCompass offers a list of Cephalexin 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 Cephalexin manufacturer or Cephalexin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cephalexin manufacturer or Cephalexin supplier.
PharmaCompass also assists you with knowing the Cephalexin API Price utilized in the formulation of products. Cephalexin API Price is not always fixed or binding as the Cephalexin Price is obtained through a variety of data sources. The Cephalexin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cephalexin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cephalexin, including repackagers and relabelers. The FDA regulates Cephalexin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cephalexin 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 Cephalexin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cephalexin supplier is an individual or a company that provides Cephalexin active pharmaceutical ingredient (API) or Cephalexin finished formulations upon request. The Cephalexin suppliers may include Cephalexin API manufacturers, exporters, distributors and traders.
click here to find a list of Cephalexin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cephalexin DMF (Drug Master File) is a document detailing the whole manufacturing process of Cephalexin active pharmaceutical ingredient (API) in detail. Different forms of Cephalexin DMFs exist exist since differing nations have different regulations, such as Cephalexin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cephalexin DMF submitted to regulatory agencies in the US is known as a USDMF. Cephalexin USDMF includes data on Cephalexin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cephalexin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cephalexin 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 Cephalexin Drug Master File in Japan (Cephalexin JDMF) empowers Cephalexin 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 Cephalexin JDMF during the approval evaluation for pharmaceutical products. At the time of Cephalexin 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 Cephalexin suppliers with JDMF on PharmaCompass.
A Cephalexin written confirmation (Cephalexin WC) is an official document issued by a regulatory agency to a Cephalexin manufacturer, verifying that the manufacturing facility of a Cephalexin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cephalexin APIs or Cephalexin finished pharmaceutical products to another nation, regulatory agencies frequently require a Cephalexin WC (written confirmation) as part of the regulatory process.
click here to find a list of Cephalexin 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 Cephalexin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cephalexin 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 Cephalexin 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 Cephalexin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cephalexin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cephalexin suppliers with NDC on PharmaCompass.
Cephalexin 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 Cephalexin 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 Cephalexin GMP manufacturer or Cephalexin GMP API supplier for your needs.
A Cephalexin CoA (Certificate of Analysis) is a formal document that attests to Cephalexin's compliance with Cephalexin specifications and serves as a tool for batch-level quality control.
Cephalexin CoA mostly includes findings from lab analyses of a specific batch. For each Cephalexin 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.
Cephalexin may be tested according to a variety of international standards, such as European Pharmacopoeia (Cephalexin EP), Cephalexin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cephalexin USP).
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