Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Epirubicin \"Medac\"
Dosage Form : Injection Solution
Dosage Strength : 2mg/ml
Packaging :
Approval Date : 25-01-2008
Application Number : 28104018006
Regulatory Info : Prescription
Registration Country : Denmark
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Aspen Epirubicin 10 Mg
Dosage Form : INJ
Dosage Strength : 10mg
Packaging : 10X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Aspen Epirubicin 50 Mg
Dosage Form : INJ
Dosage Strength : 50mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Aspen Epirubicin 50 mg/25 ml
Dosage Form : INJ
Dosage Strength : 50mg/25ml
Packaging : 25X1mg/25ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Aspen Epirubicin 10 mg/5 ml
Dosage Form : INJ
Dosage Strength : 10mg/5ml
Packaging : 5X1mg/5ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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
Related Excipient Companies
Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
22
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 Epilem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epilem, including repackagers and relabelers. The FDA regulates Epilem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epilem 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 Epilem manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epilem supplier is an individual or a company that provides Epilem active pharmaceutical ingredient (API) or Epilem finished formulations upon request. The Epilem suppliers may include Epilem API manufacturers, exporters, distributors and traders.
click here to find a list of Epilem suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Epilem DMF (Drug Master File) is a document detailing the whole manufacturing process of Epilem active pharmaceutical ingredient (API) in detail. Different forms of Epilem DMFs exist exist since differing nations have different regulations, such as Epilem USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Epilem DMF submitted to regulatory agencies in the US is known as a USDMF. Epilem USDMF includes data on Epilem's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Epilem USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Epilem 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 Epilem Drug Master File in Japan (Epilem JDMF) empowers Epilem 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 Epilem JDMF during the approval evaluation for pharmaceutical products. At the time of Epilem 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 Epilem 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 Epilem Drug Master File in Korea (Epilem KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Epilem. The MFDS reviews the Epilem KDMF as part of the drug registration process and uses the information provided in the Epilem KDMF to evaluate the safety and efficacy of the drug.
After submitting a Epilem 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 Epilem API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Epilem suppliers with KDMF on PharmaCompass.
A Epilem CEP of the European Pharmacopoeia monograph is often referred to as a Epilem Certificate of Suitability (COS). The purpose of a Epilem CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Epilem EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Epilem to their clients by showing that a Epilem CEP has been issued for it. The manufacturer submits a Epilem CEP (COS) as part of the market authorization procedure, and it takes on the role of a Epilem CEP holder for the record. Additionally, the data presented in the Epilem CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Epilem DMF.
A Epilem CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Epilem 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 Epilem suppliers with CEP (COS) on PharmaCompass.
A Epilem written confirmation (Epilem WC) is an official document issued by a regulatory agency to a Epilem manufacturer, verifying that the manufacturing facility of a Epilem active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Epilem APIs or Epilem finished pharmaceutical products to another nation, regulatory agencies frequently require a Epilem WC (written confirmation) as part of the regulatory process.
click here to find a list of Epilem 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 Epilem as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Epilem 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 Epilem 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 Epilem and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Epilem NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Epilem suppliers with NDC on PharmaCompass.
Epilem 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 Epilem 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 Epilem GMP manufacturer or Epilem GMP API supplier for your needs.
A Epilem CoA (Certificate of Analysis) is a formal document that attests to Epilem's compliance with Epilem specifications and serves as a tool for batch-level quality control.
Epilem CoA mostly includes findings from lab analyses of a specific batch. For each Epilem 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.
Epilem may be tested according to a variety of international standards, such as European Pharmacopoeia (Epilem EP), Epilem JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Epilem USP).
