Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Jai Radhe Sales is your partner for all your sourcing needs.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
CEP/COS
CA, ASMF
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USDMF
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API Imports and Exports
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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
Related Excipient Companies
Faran Shimi Pharmaceutical
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Parenteral
Direct Compression
Co-Processed Excipients
Granulation
Taste Masking
Coating Systems & Additives
Surfactant & Foaming Agents
Thickeners and Stabilizers
Solubilizers
Emulsifying Agents
Topical
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Doxorubicin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Doxorubicin, including repackagers and relabelers. The FDA regulates Doxorubicin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Doxorubicin 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Doxorubicin supplier is an individual or a company that provides Doxorubicin active pharmaceutical ingredient (API) or Doxorubicin finished formulations upon request. The Doxorubicin suppliers may include Doxorubicin API manufacturers, exporters, distributors and traders.
click here to find a list of Doxorubicin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Doxorubicin DMF (Drug Master File) is a document detailing the whole manufacturing process of Doxorubicin active pharmaceutical ingredient (API) in detail. Different forms of Doxorubicin DMFs exist exist since differing nations have different regulations, such as Doxorubicin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Doxorubicin DMF submitted to regulatory agencies in the US is known as a USDMF. Doxorubicin USDMF includes data on Doxorubicin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Doxorubicin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Doxorubicin 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 Doxorubicin Drug Master File in Japan (Doxorubicin JDMF) empowers Doxorubicin 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Doxorubicin 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 Doxorubicin 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 Doxorubicin Drug Master File in Korea (Doxorubicin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Doxorubicin. The MFDS reviews the Doxorubicin KDMF as part of the drug registration process and uses the information provided in the Doxorubicin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Doxorubicin 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Doxorubicin suppliers with KDMF on PharmaCompass.
A Doxorubicin CEP of the European Pharmacopoeia monograph is often referred to as a Doxorubicin Certificate of Suitability (COS). The purpose of a Doxorubicin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Doxorubicin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Doxorubicin to their clients by showing that a Doxorubicin CEP has been issued for it. The manufacturer submits a Doxorubicin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Doxorubicin CEP holder for the record. Additionally, the data presented in the Doxorubicin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Doxorubicin DMF.
A Doxorubicin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Doxorubicin 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 Doxorubicin suppliers with CEP (COS) on PharmaCompass.
A Doxorubicin written confirmation (Doxorubicin WC) is an official document issued by a regulatory agency to a Doxorubicin manufacturer, verifying that the manufacturing facility of a Doxorubicin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Doxorubicin APIs or Doxorubicin finished pharmaceutical products to another nation, regulatory agencies frequently require a Doxorubicin WC (written confirmation) as part of the regulatory process.
click here to find a list of Doxorubicin 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 Doxorubicin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Doxorubicin 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Doxorubicin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Doxorubicin suppliers with NDC on PharmaCompass.
Doxorubicin 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 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 GMP manufacturer or Doxorubicin GMP API supplier for your needs.
A Doxorubicin CoA (Certificate of Analysis) is a formal document that attests to Doxorubicin's compliance with Doxorubicin specifications and serves as a tool for batch-level quality control.
Doxorubicin CoA mostly includes findings from lab analyses of a specific batch. For each Doxorubicin 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Doxorubicin EP), Doxorubicin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Doxorubicin USP).
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