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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
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ABOUT THIS PAGE
A Daunorubicin HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daunorubicin HCl, including repackagers and relabelers. The FDA regulates Daunorubicin HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daunorubicin 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 Daunorubicin HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Daunorubicin HCl supplier is an individual or a company that provides Daunorubicin HCl active pharmaceutical ingredient (API) or Daunorubicin HCl finished formulations upon request. The Daunorubicin HCl suppliers may include Daunorubicin HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Daunorubicin HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Daunorubicin HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Daunorubicin HCl active pharmaceutical ingredient (API) in detail. Different forms of Daunorubicin HCl DMFs exist exist since differing nations have different regulations, such as Daunorubicin HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Daunorubicin HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Daunorubicin HCl USDMF includes data on Daunorubicin HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Daunorubicin HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Daunorubicin 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 Daunorubicin HCl Drug Master File in Japan (Daunorubicin HCl JDMF) empowers Daunorubicin 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 Daunorubicin HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Daunorubicin 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 Daunorubicin 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 Daunorubicin HCl Drug Master File in Korea (Daunorubicin HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Daunorubicin HCl. The MFDS reviews the Daunorubicin HCl KDMF as part of the drug registration process and uses the information provided in the Daunorubicin HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Daunorubicin 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 Daunorubicin HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Daunorubicin HCl suppliers with KDMF on PharmaCompass.
A Daunorubicin HCl CEP of the European Pharmacopoeia monograph is often referred to as a Daunorubicin HCl Certificate of Suitability (COS). The purpose of a Daunorubicin HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Daunorubicin HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Daunorubicin HCl to their clients by showing that a Daunorubicin HCl CEP has been issued for it. The manufacturer submits a Daunorubicin HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Daunorubicin HCl CEP holder for the record. Additionally, the data presented in the Daunorubicin HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Daunorubicin HCl DMF.
A Daunorubicin HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Daunorubicin 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 Daunorubicin HCl suppliers with CEP (COS) on PharmaCompass.
A Daunorubicin HCl written confirmation (Daunorubicin HCl WC) is an official document issued by a regulatory agency to a Daunorubicin HCl manufacturer, verifying that the manufacturing facility of a Daunorubicin HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Daunorubicin HCl APIs or Daunorubicin HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Daunorubicin HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Daunorubicin 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 Daunorubicin HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Daunorubicin 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 Daunorubicin 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 Daunorubicin HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Daunorubicin HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Daunorubicin HCl suppliers with NDC on PharmaCompass.
Daunorubicin 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 Daunorubicin 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 Daunorubicin HCl GMP manufacturer or Daunorubicin HCl GMP API supplier for your needs.
A Daunorubicin HCl CoA (Certificate of Analysis) is a formal document that attests to Daunorubicin HCl's compliance with Daunorubicin HCl specifications and serves as a tool for batch-level quality control.
Daunorubicin HCl CoA mostly includes findings from lab analyses of a specific batch. For each Daunorubicin 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.
Daunorubicin HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Daunorubicin HCl EP), Daunorubicin HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Daunorubicin HCl USP).
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