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DOSAGE - INJECTABLE;INJECTION - 200MG/100ML (...DOSAGE - INJECTABLE;INJECTION - 200MG/100ML (2MG/ML)
USFDA APPLICATION NUMBER - 50778
DOSAGE - INJECTABLE;INJECTION - 50MG/25ML (2M...DOSAGE - INJECTABLE;INJECTION - 50MG/25ML (2MG/ML)
USFDA APPLICATION NUMBER - 50778
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ABOUT THIS PAGE
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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 Epidoxorubicin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epidoxorubicin Hydrochloride, including repackagers and relabelers. The FDA regulates Epidoxorubicin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epidoxorubicin Hydrochloride 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 Epidoxorubicin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epidoxorubicin Hydrochloride supplier is an individual or a company that provides Epidoxorubicin Hydrochloride active pharmaceutical ingredient (API) or Epidoxorubicin Hydrochloride finished formulations upon request. The Epidoxorubicin Hydrochloride suppliers may include Epidoxorubicin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Epidoxorubicin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Epidoxorubicin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Epidoxorubicin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Epidoxorubicin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Epidoxorubicin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Epidoxorubicin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Epidoxorubicin Hydrochloride USDMF includes data on Epidoxorubicin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Epidoxorubicin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Epidoxorubicin Hydrochloride 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 Epidoxorubicin Hydrochloride Drug Master File in Japan (Epidoxorubicin Hydrochloride JDMF) empowers Epidoxorubicin Hydrochloride 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 Epidoxorubicin Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Epidoxorubicin Hydrochloride 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 Epidoxorubicin Hydrochloride 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 Epidoxorubicin Hydrochloride Drug Master File in Korea (Epidoxorubicin Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Epidoxorubicin Hydrochloride. The MFDS reviews the Epidoxorubicin Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Epidoxorubicin Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Epidoxorubicin Hydrochloride 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 Epidoxorubicin Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Epidoxorubicin Hydrochloride suppliers with KDMF on PharmaCompass.
A Epidoxorubicin Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Epidoxorubicin Hydrochloride Certificate of Suitability (COS). The purpose of a Epidoxorubicin Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Epidoxorubicin Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Epidoxorubicin Hydrochloride to their clients by showing that a Epidoxorubicin Hydrochloride CEP has been issued for it. The manufacturer submits a Epidoxorubicin Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Epidoxorubicin Hydrochloride CEP holder for the record. Additionally, the data presented in the Epidoxorubicin Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Epidoxorubicin Hydrochloride DMF.
A Epidoxorubicin Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Epidoxorubicin Hydrochloride 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 Epidoxorubicin Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Epidoxorubicin Hydrochloride written confirmation (Epidoxorubicin Hydrochloride WC) is an official document issued by a regulatory agency to a Epidoxorubicin Hydrochloride manufacturer, verifying that the manufacturing facility of a Epidoxorubicin Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Epidoxorubicin Hydrochloride APIs or Epidoxorubicin Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Epidoxorubicin Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Epidoxorubicin Hydrochloride 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 Epidoxorubicin Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Epidoxorubicin Hydrochloride 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 Epidoxorubicin Hydrochloride 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 Epidoxorubicin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Epidoxorubicin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Epidoxorubicin Hydrochloride suppliers with NDC on PharmaCompass.
Epidoxorubicin Hydrochloride 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 Epidoxorubicin Hydrochloride 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 Epidoxorubicin Hydrochloride GMP manufacturer or Epidoxorubicin Hydrochloride GMP API supplier for your needs.
A Epidoxorubicin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Epidoxorubicin Hydrochloride's compliance with Epidoxorubicin Hydrochloride specifications and serves as a tool for batch-level quality control.
Epidoxorubicin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Epidoxorubicin Hydrochloride 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.
Epidoxorubicin Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Epidoxorubicin Hydrochloride EP), Epidoxorubicin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Epidoxorubicin Hydrochloride USP).
