Synopsis
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CEP/COS
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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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NDC 
KDMF
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
EU-WC
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39274
Submission : 2023-12-29
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39141
Submission : 2023-12-01
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38207
Submission : 2023-03-31
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-07-28
Valid Till : 2025-11-30
Written Confirmation Number : WC-0390
Address of the Firm : Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District -532409, Andhr...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-07-28
Valid Till : 2025-11-30
Written Confirmation Number : WC-0390
Address of the Firm : Devunipalavalasa Village, Ranasthalam Mandal, Srikakulam District -532409, Andhr...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the ...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
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 critical and high-g...
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
About the Company : Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing of generic APIs and ...
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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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
4-Chloro-6,7-dimethoxyquinoline
CAS Number : 35654-56-9
End Use API : Cabozantinib
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.
1-((4-Fluoro phenyl) Carbamoyl) Cyclopropane Carbo...
CAS Number : 849217-48-7
End Use API : Cabozantinib
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-((6,7-Dimethoxyquinolin-4-yl)oxy)aniline
CAS Number : 190728-25-7
End Use API : Cabozantinib
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.
Cyclopropane-1,1-dicarboxylic acid methyl ester
CAS Number : 113020-21-6
End Use API : Cabozantinib
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.
1,1-Cyclopropanedicarboxylic acid
CAS Number : 598-10-7
End Use API : Cabozantinib
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 - CAPSULE;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 203756
DOSAGE - CAPSULE;ORAL - EQ 80MG BASE
USFDA APPLICATION NUMBER - 203756
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Topical
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DATA COMPILATION #PharmaFlow
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Global Sales Information
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ABOUT THIS PAGE
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PharmaCompass offers a list of Cabozantinib 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 Cabozantinib manufacturer or Cabozantinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cabozantinib manufacturer or Cabozantinib supplier.
PharmaCompass also assists you with knowing the Cabozantinib API Price utilized in the formulation of products. Cabozantinib API Price is not always fixed or binding as the Cabozantinib Price is obtained through a variety of data sources. The Cabozantinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cabozantinib S-Malate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cabozantinib S-Malate, including repackagers and relabelers. The FDA regulates Cabozantinib S-Malate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cabozantinib S-Malate 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 Cabozantinib S-Malate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cabozantinib S-Malate supplier is an individual or a company that provides Cabozantinib S-Malate active pharmaceutical ingredient (API) or Cabozantinib S-Malate finished formulations upon request. The Cabozantinib S-Malate suppliers may include Cabozantinib S-Malate API manufacturers, exporters, distributors and traders.
click here to find a list of Cabozantinib S-Malate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cabozantinib S-Malate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cabozantinib S-Malate active pharmaceutical ingredient (API) in detail. Different forms of Cabozantinib S-Malate DMFs exist exist since differing nations have different regulations, such as Cabozantinib S-Malate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cabozantinib S-Malate DMF submitted to regulatory agencies in the US is known as a USDMF. Cabozantinib S-Malate USDMF includes data on Cabozantinib S-Malate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cabozantinib S-Malate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cabozantinib S-Malate suppliers with USDMF 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 Cabozantinib S-Malate Drug Master File in Korea (Cabozantinib S-Malate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cabozantinib S-Malate. The MFDS reviews the Cabozantinib S-Malate KDMF as part of the drug registration process and uses the information provided in the Cabozantinib S-Malate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cabozantinib S-Malate 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 Cabozantinib S-Malate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cabozantinib S-Malate suppliers with KDMF on PharmaCompass.
A Cabozantinib S-Malate written confirmation (Cabozantinib S-Malate WC) is an official document issued by a regulatory agency to a Cabozantinib S-Malate manufacturer, verifying that the manufacturing facility of a Cabozantinib S-Malate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cabozantinib S-Malate APIs or Cabozantinib S-Malate finished pharmaceutical products to another nation, regulatory agencies frequently require a Cabozantinib S-Malate WC (written confirmation) as part of the regulatory process.
click here to find a list of Cabozantinib S-Malate 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 Cabozantinib S-Malate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cabozantinib S-Malate 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 Cabozantinib S-Malate 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 Cabozantinib S-Malate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cabozantinib S-Malate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cabozantinib S-Malate suppliers with NDC on PharmaCompass.
Cabozantinib S-Malate 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 Cabozantinib S-Malate 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 Cabozantinib S-Malate GMP manufacturer or Cabozantinib S-Malate GMP API supplier for your needs.
A Cabozantinib S-Malate CoA (Certificate of Analysis) is a formal document that attests to Cabozantinib S-Malate's compliance with Cabozantinib S-Malate specifications and serves as a tool for batch-level quality control.
Cabozantinib S-Malate CoA mostly includes findings from lab analyses of a specific batch. For each Cabozantinib S-Malate 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.
Cabozantinib S-Malate may be tested according to a variety of international standards, such as European Pharmacopoeia (Cabozantinib S-Malate EP), Cabozantinib S-Malate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cabozantinib S-Malate USP).
