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