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API SUPPLIERS
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USDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-29
Pay. Date : 2012-11-08
DMF Number : 13726
Submission : 1998-09-01
Status :
Type : II
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API Imports and Exports
Drugs in Development
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DOSAGE - INJECTABLE;INJECTION - 150MG/75ML
USFDA APPLICATION NUMBER - 50629
DOSAGE - INJECTABLE;INJECTION - 200MG/100ML
USFDA APPLICATION NUMBER - 50629
DOSAGE - INJECTABLE;INJECTION - 2MG/ML
USFDA APPLICATION NUMBER - 50629
DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 20...DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 20MG/10ML (2MG/ML)
USFDA APPLICATION NUMBER - 50718
DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 50...DOSAGE - INJECTABLE, LIPOSOMAL;INJECTION - 50MG/25ML (2MG/ML)
USFDA APPLICATION NUMBER - 50718
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Doxorubicin 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 Doxorubicin Hydrochloride manufacturer or Doxorubicin Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Doxorubicin Hydrochloride manufacturer or Doxorubicin Hydrochloride supplier.
PharmaCompass also assists you with knowing the Doxorubicin Hydrochloride API Price utilized in the formulation of products. Doxorubicin Hydrochloride API Price is not always fixed or binding as the Doxorubicin Hydrochloride Price is obtained through a variety of data sources. The Doxorubicin Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Doxorubicin HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Doxorubicin HCl, including repackagers and relabelers. The FDA regulates Doxorubicin HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Doxorubicin 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 Doxorubicin HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Doxorubicin HCl supplier is an individual or a company that provides Doxorubicin HCl active pharmaceutical ingredient (API) or Doxorubicin HCl finished formulations upon request. The Doxorubicin HCl suppliers may include Doxorubicin HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Doxorubicin HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Doxorubicin HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Doxorubicin HCl active pharmaceutical ingredient (API) in detail. Different forms of Doxorubicin HCl DMFs exist exist since differing nations have different regulations, such as Doxorubicin HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Doxorubicin HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Doxorubicin HCl USDMF includes data on Doxorubicin HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Doxorubicin HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Doxorubicin HCl Drug Master File in Japan (Doxorubicin HCl JDMF) empowers Doxorubicin 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 Doxorubicin HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Doxorubicin HCl JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Doxorubicin HCl Drug Master File in Korea (Doxorubicin HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Doxorubicin HCl. The MFDS reviews the Doxorubicin HCl KDMF as part of the drug registration process and uses the information provided in the Doxorubicin HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Doxorubicin 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 Doxorubicin HCl API can apply through the Korea Drug Master File (KDMF).
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A Doxorubicin HCl CEP of the European Pharmacopoeia monograph is often referred to as a Doxorubicin HCl Certificate of Suitability (COS). The purpose of a Doxorubicin HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Doxorubicin HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Doxorubicin HCl to their clients by showing that a Doxorubicin HCl CEP has been issued for it. The manufacturer submits a Doxorubicin HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Doxorubicin HCl CEP holder for the record. Additionally, the data presented in the Doxorubicin HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Doxorubicin HCl DMF.
A Doxorubicin HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Doxorubicin HCl CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Doxorubicin HCl written confirmation (Doxorubicin HCl WC) is an official document issued by a regulatory agency to a Doxorubicin HCl manufacturer, verifying that the manufacturing facility of a Doxorubicin HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Doxorubicin HCl APIs or Doxorubicin HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Doxorubicin HCl WC (written confirmation) as part of the regulatory process.
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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 Doxorubicin HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Doxorubicin 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 Doxorubicin 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 Doxorubicin HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Doxorubicin HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Doxorubicin HCl suppliers with NDC on PharmaCompass.
Doxorubicin 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 Doxorubicin 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 Doxorubicin HCl GMP manufacturer or Doxorubicin HCl GMP API supplier for your needs.
A Doxorubicin HCl CoA (Certificate of Analysis) is a formal document that attests to Doxorubicin HCl's compliance with Doxorubicin HCl specifications and serves as a tool for batch-level quality control.
Doxorubicin HCl CoA mostly includes findings from lab analyses of a specific batch. For each Doxorubicin 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.
Doxorubicin HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Doxorubicin HCl EP), Doxorubicin HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Doxorubicin HCl USP).
