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