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