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