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API SUPPLIERS
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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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Irinotecan Hydrochloride Trihydrate
Certificate Number : CEP 2017-236 - Rev 02
Status : Valid
Issue Date : 2023-09-22
Type : Chemical
Substance Number : 2675
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API Imports and Exports
Drugs in Development
Lead Product(s) : Trilaciclib,Irinotecan Hydrochloride,Oxaliplatin
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : G1 Therapeutics, Inc
Deal Size : Not Applicable
Deal Type : Not Applicable
Fermion's Long Term Customer G1 Therapeutics Received FDA Approval For COSELA™ (Trilaciclib)
Details : The FDA approved COSELA™ (trilaciclib) as the first and only myeloprotection therapy to decrease the incidence of chemotherapy-induced myelosuppression.
Product Name : Cosela
Product Type : Small molecule
Upfront Cash : Not Applicable
February 12, 2021
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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
(S)-8-Ethyl-8-hydroxy-2,3,5,8-tetrahydro-6-oxa-3a-...
CAS Number : 110351-94-5
End Use API : Irinotecan Hydrochloride
About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
2’-Amino-5’-hydroxypropiophenone
CAS Number : 35364-15-9
End Use API : Irinotecan Hydrochloride
About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
7-Ethyl-10-hydroxycamptothecin (SN-38)
CAS Number : 86639-52-3
End Use API : Irinotecan Hydrochloride
About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
2’-Amino-5’-hydroxypropiophenone (AHP)
CAS Number : 35364-15-9
End Use API : Irinotecan Hydrochloride
About The Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commer...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
CAS Number : 4897-50-1
End Use API : Irinotecan Hydrochloride
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
4-Piperidinylpiperidine dihydrochloride
CAS Number : 4876-60-2
End Use API : Irinotecan Hydrochloride
About The Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for...
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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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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 Irinotecan Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Irinotecan Hydrochloride, including repackagers and relabelers. The FDA regulates Irinotecan Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Irinotecan 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 Irinotecan Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Irinotecan Hydrochloride supplier is an individual or a company that provides Irinotecan Hydrochloride active pharmaceutical ingredient (API) or Irinotecan Hydrochloride finished formulations upon request. The Irinotecan Hydrochloride suppliers may include Irinotecan Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Irinotecan Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Irinotecan Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Irinotecan Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Irinotecan Hydrochloride DMFs exist exist since differing nations have different regulations, such as Irinotecan Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Irinotecan Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Irinotecan Hydrochloride USDMF includes data on Irinotecan Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Irinotecan Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Irinotecan 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 Irinotecan Hydrochloride Drug Master File in Japan (Irinotecan Hydrochloride JDMF) empowers Irinotecan 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 Irinotecan Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Irinotecan 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 Irinotecan Hydrochloride 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 Hydrochloride Drug Master File in Korea (Irinotecan Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Irinotecan Hydrochloride. The MFDS reviews the Irinotecan Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Irinotecan Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Irinotecan Hydrochloride 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 Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Irinotecan Hydrochloride suppliers with KDMF on PharmaCompass.
A Irinotecan Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Irinotecan Hydrochloride Certificate of Suitability (COS). The purpose of a Irinotecan Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Irinotecan Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Irinotecan Hydrochloride to their clients by showing that a Irinotecan Hydrochloride CEP has been issued for it. The manufacturer submits a Irinotecan Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Irinotecan Hydrochloride CEP holder for the record. Additionally, the data presented in the Irinotecan Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Irinotecan Hydrochloride DMF.
A Irinotecan Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Irinotecan 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 Irinotecan Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Irinotecan Hydrochloride written confirmation (Irinotecan Hydrochloride WC) is an official document issued by a regulatory agency to a Irinotecan Hydrochloride manufacturer, verifying that the manufacturing facility of a Irinotecan Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Irinotecan Hydrochloride APIs or Irinotecan Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Irinotecan Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Irinotecan Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Irinotecan 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 Irinotecan 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 Irinotecan Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Irinotecan Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Irinotecan Hydrochloride suppliers with NDC on PharmaCompass.
Irinotecan 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 Irinotecan 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 Irinotecan Hydrochloride GMP manufacturer or Irinotecan Hydrochloride GMP API supplier for your needs.
A Irinotecan Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Irinotecan Hydrochloride's compliance with Irinotecan Hydrochloride specifications and serves as a tool for batch-level quality control.
Irinotecan Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Irinotecan 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.
Irinotecan Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Irinotecan Hydrochloride EP), Irinotecan Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Irinotecan Hydrochloride USP).
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