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VMF
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API SUPPLIERS
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USDMF
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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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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Surfactant & Foaming Agents
Chewable & Orodispersible Aids
Emulsifying Agents
Topical
Co-Processed Excipients
Thickeners and Stabilizers
Solubilizers
Dry Powder Inhalation
Soft Gelatin
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Digital Content
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US Medicaid Prescriptions
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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 Onivyde manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Onivyde, including repackagers and relabelers. The FDA regulates Onivyde manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Onivyde 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 Onivyde manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Onivyde supplier is an individual or a company that provides Onivyde active pharmaceutical ingredient (API) or Onivyde finished formulations upon request. The Onivyde suppliers may include Onivyde API manufacturers, exporters, distributors and traders.
click here to find a list of Onivyde suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Onivyde DMF (Drug Master File) is a document detailing the whole manufacturing process of Onivyde active pharmaceutical ingredient (API) in detail. Different forms of Onivyde DMFs exist exist since differing nations have different regulations, such as Onivyde USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Onivyde DMF submitted to regulatory agencies in the US is known as a USDMF. Onivyde USDMF includes data on Onivyde's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Onivyde USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Onivyde 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 Onivyde Drug Master File in Japan (Onivyde JDMF) empowers Onivyde 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 Onivyde JDMF during the approval evaluation for pharmaceutical products. At the time of Onivyde 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 Onivyde 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 Onivyde Drug Master File in Korea (Onivyde KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Onivyde. The MFDS reviews the Onivyde KDMF as part of the drug registration process and uses the information provided in the Onivyde KDMF to evaluate the safety and efficacy of the drug.
After submitting a Onivyde 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 Onivyde API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Onivyde suppliers with KDMF on PharmaCompass.
A Onivyde CEP of the European Pharmacopoeia monograph is often referred to as a Onivyde Certificate of Suitability (COS). The purpose of a Onivyde CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Onivyde EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Onivyde to their clients by showing that a Onivyde CEP has been issued for it. The manufacturer submits a Onivyde CEP (COS) as part of the market authorization procedure, and it takes on the role of a Onivyde CEP holder for the record. Additionally, the data presented in the Onivyde CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Onivyde DMF.
A Onivyde CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Onivyde 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 Onivyde suppliers with CEP (COS) on PharmaCompass.
A Onivyde written confirmation (Onivyde WC) is an official document issued by a regulatory agency to a Onivyde manufacturer, verifying that the manufacturing facility of a Onivyde active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Onivyde APIs or Onivyde finished pharmaceutical products to another nation, regulatory agencies frequently require a Onivyde WC (written confirmation) as part of the regulatory process.
click here to find a list of Onivyde 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 Onivyde as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Onivyde 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 Onivyde 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 Onivyde and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Onivyde NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Onivyde suppliers with NDC on PharmaCompass.
Onivyde 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 Onivyde 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 Onivyde GMP manufacturer or Onivyde GMP API supplier for your needs.
A Onivyde CoA (Certificate of Analysis) is a formal document that attests to Onivyde's compliance with Onivyde specifications and serves as a tool for batch-level quality control.
Onivyde CoA mostly includes findings from lab analyses of a specific batch. For each Onivyde 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.
Onivyde may be tested according to a variety of international standards, such as European Pharmacopoeia (Onivyde EP), Onivyde JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Onivyde USP).
