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