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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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API Imports and Exports
Drugs in Development
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DOSAGE - INJECTABLE;INJECTION - 100MG/5ML (20...DOSAGE - INJECTABLE;INJECTION - 100MG/5ML (20MG/ML)
USFDA APPLICATION NUMBER - 20571
DOSAGE - INJECTABLE;INJECTION - 300MG/15ML (2...DOSAGE - INJECTABLE;INJECTION - 300MG/15ML (20MG/ML)
USFDA APPLICATION NUMBER - 20571
DOSAGE - INJECTABLE;INJECTION - 40MG/2ML (20M...DOSAGE - INJECTABLE;INJECTION - 40MG/2ML (20MG/ML)
USFDA APPLICATION NUMBER - 20571
DOSAGE - INJECTABLE, LIPOSOMAL;INTRAVENOUS - ...DOSAGE - INJECTABLE, LIPOSOMAL;INTRAVENOUS - EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)
USFDA APPLICATION NUMBER - 207793
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
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Digital Content
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US Medicaid Prescriptions
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ABOUT THIS PAGE
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PharmaCompass offers a list of Irinotecan 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 Irinotecan Hydrochloride manufacturer or Irinotecan Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Irinotecan Hydrochloride manufacturer or Irinotecan Hydrochloride supplier.
PharmaCompass also assists you with knowing the Irinotecan Hydrochloride API Price utilized in the formulation of products. Irinotecan Hydrochloride API Price is not always fixed or binding as the Irinotecan Hydrochloride Price is obtained through a variety of data sources. The Irinotecan Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 042LAQ1IIS manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 042LAQ1IIS, including repackagers and relabelers. The FDA regulates 042LAQ1IIS manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 042LAQ1IIS 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 042LAQ1IIS manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 042LAQ1IIS supplier is an individual or a company that provides 042LAQ1IIS active pharmaceutical ingredient (API) or 042LAQ1IIS finished formulations upon request. The 042LAQ1IIS suppliers may include 042LAQ1IIS API manufacturers, exporters, distributors and traders.
click here to find a list of 042LAQ1IIS suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 042LAQ1IIS DMF (Drug Master File) is a document detailing the whole manufacturing process of 042LAQ1IIS active pharmaceutical ingredient (API) in detail. Different forms of 042LAQ1IIS DMFs exist exist since differing nations have different regulations, such as 042LAQ1IIS USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 042LAQ1IIS DMF submitted to regulatory agencies in the US is known as a USDMF. 042LAQ1IIS USDMF includes data on 042LAQ1IIS's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 042LAQ1IIS USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 042LAQ1IIS 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 042LAQ1IIS Drug Master File in Japan (042LAQ1IIS JDMF) empowers 042LAQ1IIS 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 042LAQ1IIS JDMF during the approval evaluation for pharmaceutical products. At the time of 042LAQ1IIS 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 042LAQ1IIS 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 042LAQ1IIS Drug Master File in Korea (042LAQ1IIS KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 042LAQ1IIS. The MFDS reviews the 042LAQ1IIS KDMF as part of the drug registration process and uses the information provided in the 042LAQ1IIS KDMF to evaluate the safety and efficacy of the drug.
After submitting a 042LAQ1IIS 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 042LAQ1IIS API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 042LAQ1IIS suppliers with KDMF on PharmaCompass.
A 042LAQ1IIS CEP of the European Pharmacopoeia monograph is often referred to as a 042LAQ1IIS Certificate of Suitability (COS). The purpose of a 042LAQ1IIS CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 042LAQ1IIS EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 042LAQ1IIS to their clients by showing that a 042LAQ1IIS CEP has been issued for it. The manufacturer submits a 042LAQ1IIS CEP (COS) as part of the market authorization procedure, and it takes on the role of a 042LAQ1IIS CEP holder for the record. Additionally, the data presented in the 042LAQ1IIS CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 042LAQ1IIS DMF.
A 042LAQ1IIS CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 042LAQ1IIS 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 042LAQ1IIS suppliers with CEP (COS) on PharmaCompass.
A 042LAQ1IIS written confirmation (042LAQ1IIS WC) is an official document issued by a regulatory agency to a 042LAQ1IIS manufacturer, verifying that the manufacturing facility of a 042LAQ1IIS active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 042LAQ1IIS APIs or 042LAQ1IIS finished pharmaceutical products to another nation, regulatory agencies frequently require a 042LAQ1IIS WC (written confirmation) as part of the regulatory process.
click here to find a list of 042LAQ1IIS 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 042LAQ1IIS as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 042LAQ1IIS 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 042LAQ1IIS 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 042LAQ1IIS and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 042LAQ1IIS NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 042LAQ1IIS suppliers with NDC on PharmaCompass.
042LAQ1IIS 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 042LAQ1IIS 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 042LAQ1IIS GMP manufacturer or 042LAQ1IIS GMP API supplier for your needs.
A 042LAQ1IIS CoA (Certificate of Analysis) is a formal document that attests to 042LAQ1IIS's compliance with 042LAQ1IIS specifications and serves as a tool for batch-level quality control.
042LAQ1IIS CoA mostly includes findings from lab analyses of a specific batch. For each 042LAQ1IIS 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.
042LAQ1IIS may be tested according to a variety of international standards, such as European Pharmacopoeia (042LAQ1IIS EP), 042LAQ1IIS JP (Japanese Pharmacopeia) and the US Pharmacopoeia (042LAQ1IIS USP).
