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