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API SUPPLIERS
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
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CEP/COS 
JDMF
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KDMF
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
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USDMF
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GDUFA
DMF Review : Complete
Rev. Date : 2013-09-14
Pay. Date : 2013-09-05
DMF Number : 20649
Submission : 2007-06-29
Status :
Type : II
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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
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ABOUT THIS PAGE
A Irinotecan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Irinotecan, including repackagers and relabelers. The FDA regulates Irinotecan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Irinotecan 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 Irinotecan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Irinotecan supplier is an individual or a company that provides Irinotecan active pharmaceutical ingredient (API) or Irinotecan finished formulations upon request. The Irinotecan suppliers may include Irinotecan API manufacturers, exporters, distributors and traders.
click here to find a list of Irinotecan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Irinotecan DMF (Drug Master File) is a document detailing the whole manufacturing process of Irinotecan active pharmaceutical ingredient (API) in detail. Different forms of Irinotecan DMFs exist exist since differing nations have different regulations, such as Irinotecan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Irinotecan DMF submitted to regulatory agencies in the US is known as a USDMF. Irinotecan USDMF includes data on Irinotecan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Irinotecan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Irinotecan 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 Irinotecan Drug Master File in Japan (Irinotecan JDMF) empowers Irinotecan 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 Irinotecan JDMF during the approval evaluation for pharmaceutical products. At the time of Irinotecan 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 Irinotecan 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 Irinotecan Drug Master File in Korea (Irinotecan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Irinotecan. The MFDS reviews the Irinotecan KDMF as part of the drug registration process and uses the information provided in the Irinotecan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Irinotecan 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 Irinotecan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Irinotecan suppliers with KDMF on PharmaCompass.
A Irinotecan CEP of the European Pharmacopoeia monograph is often referred to as a Irinotecan Certificate of Suitability (COS). The purpose of a Irinotecan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Irinotecan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Irinotecan to their clients by showing that a Irinotecan CEP has been issued for it. The manufacturer submits a Irinotecan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Irinotecan CEP holder for the record. Additionally, the data presented in the Irinotecan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Irinotecan DMF.
A Irinotecan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Irinotecan 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 Irinotecan suppliers with CEP (COS) on PharmaCompass.
A Irinotecan written confirmation (Irinotecan WC) is an official document issued by a regulatory agency to a Irinotecan manufacturer, verifying that the manufacturing facility of a Irinotecan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Irinotecan APIs or Irinotecan finished pharmaceutical products to another nation, regulatory agencies frequently require a Irinotecan WC (written confirmation) as part of the regulatory process.
click here to find a list of Irinotecan 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 Irinotecan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Irinotecan 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 Irinotecan 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 Irinotecan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Irinotecan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Irinotecan suppliers with NDC on PharmaCompass.
Irinotecan 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 Irinotecan 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 Irinotecan GMP manufacturer or Irinotecan GMP API supplier for your needs.
A Irinotecan CoA (Certificate of Analysis) is a formal document that attests to Irinotecan's compliance with Irinotecan specifications and serves as a tool for batch-level quality control.
Irinotecan CoA mostly includes findings from lab analyses of a specific batch. For each Irinotecan 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.
Irinotecan may be tested according to a variety of international standards, such as European Pharmacopoeia (Irinotecan EP), Irinotecan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Irinotecan USP).
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