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KDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33811
Submission : 2019-11-04
Status :
Type : II
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 : 2012-11-09
DMF Number : 13791
Submission : 1998-09-01
Status :
Type : II
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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mitomycin-C 2mg
Dosage Form : INJ
Dosage Strength : 2mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Mitomycin-C 10 mg
Dosage Form : INJ
Dosage Strength : 10mg
Packaging : 1X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 2MG/Vial
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 10MG/Vial
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 20MG/Vial
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 40MG/Vial
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
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Excipient Details : Mannogem (mannitol powder) is an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Mitomycin 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 Mitomycin manufacturer or Mitomycin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mitomycin manufacturer or Mitomycin supplier.
PharmaCompass also assists you with knowing the Mitomycin API Price utilized in the formulation of products. Mitomycin API Price is not always fixed or binding as the Mitomycin Price is obtained through a variety of data sources. The Mitomycin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mito-C manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mito-C, including repackagers and relabelers. The FDA regulates Mito-C manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mito-C 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 Mito-C manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mito-C supplier is an individual or a company that provides Mito-C active pharmaceutical ingredient (API) or Mito-C finished formulations upon request. The Mito-C suppliers may include Mito-C API manufacturers, exporters, distributors and traders.
click here to find a list of Mito-C suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mito-C DMF (Drug Master File) is a document detailing the whole manufacturing process of Mito-C active pharmaceutical ingredient (API) in detail. Different forms of Mito-C DMFs exist exist since differing nations have different regulations, such as Mito-C USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mito-C DMF submitted to regulatory agencies in the US is known as a USDMF. Mito-C USDMF includes data on Mito-C's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mito-C USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mito-C 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 Mito-C Drug Master File in Japan (Mito-C JDMF) empowers Mito-C 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 Mito-C JDMF during the approval evaluation for pharmaceutical products. At the time of Mito-C 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 Mito-C suppliers with JDMF on PharmaCompass.
A Mito-C CEP of the European Pharmacopoeia monograph is often referred to as a Mito-C Certificate of Suitability (COS). The purpose of a Mito-C CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mito-C EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mito-C to their clients by showing that a Mito-C CEP has been issued for it. The manufacturer submits a Mito-C CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mito-C CEP holder for the record. Additionally, the data presented in the Mito-C CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mito-C DMF.
A Mito-C CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mito-C 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 Mito-C suppliers with CEP (COS) on PharmaCompass.
A Mito-C written confirmation (Mito-C WC) is an official document issued by a regulatory agency to a Mito-C manufacturer, verifying that the manufacturing facility of a Mito-C active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mito-C APIs or Mito-C finished pharmaceutical products to another nation, regulatory agencies frequently require a Mito-C WC (written confirmation) as part of the regulatory process.
click here to find a list of Mito-C 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 Mito-C as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mito-C 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 Mito-C 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 Mito-C and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mito-C NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mito-C suppliers with NDC on PharmaCompass.
Mito-C 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 Mito-C 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 Mito-C GMP manufacturer or Mito-C GMP API supplier for your needs.
A Mito-C CoA (Certificate of Analysis) is a formal document that attests to Mito-C's compliance with Mito-C specifications and serves as a tool for batch-level quality control.
Mito-C CoA mostly includes findings from lab analyses of a specific batch. For each Mito-C 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.
Mito-C may be tested according to a variety of international standards, such as European Pharmacopoeia (Mito-C EP), Mito-C JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mito-C USP).
