Synopsis
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CEP/COS
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JDMF
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VMF
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South Africa
DRUG PRODUCT COMPOSITIONS0
Weekly News Recap #Phispers
API SUPPLIERS
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
NDC 
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
NDC
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
NDC
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USDMF
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39785
Submission : 2024-03-26
Status :
Type : II
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39757
Submission : 2024-03-22
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
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
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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 vertically integrated fast-growing Pharmaceutical company headquartered in Hyderabad with best-in-class facilities & a commitment to operational excellence, quality, ...
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
About the Company : Specializing in natural & oncology APIs, we establish R&D and production platforms for new salt, crystal form & synthetic biology research. We cooperate with clients for IND, NDA, ...
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, ...
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...
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...
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Drugs in Development
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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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Parenteral
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30 Nov 2024
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ABOUT THIS PAGE
A Cabozantinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cabozantinib, including repackagers and relabelers. The FDA regulates Cabozantinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cabozantinib 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cabozantinib supplier is an individual or a company that provides Cabozantinib active pharmaceutical ingredient (API) or Cabozantinib finished formulations upon request. The Cabozantinib suppliers may include Cabozantinib API manufacturers, exporters, distributors and traders.
click here to find a list of Cabozantinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cabozantinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Cabozantinib active pharmaceutical ingredient (API) in detail. Different forms of Cabozantinib DMFs exist exist since differing nations have different regulations, such as Cabozantinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cabozantinib DMF submitted to regulatory agencies in the US is known as a USDMF. Cabozantinib USDMF includes data on Cabozantinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cabozantinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cabozantinib 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 Drug Master File in Korea (Cabozantinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cabozantinib. The MFDS reviews the Cabozantinib KDMF as part of the drug registration process and uses the information provided in the Cabozantinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cabozantinib 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cabozantinib suppliers with KDMF on PharmaCompass.
A Cabozantinib written confirmation (Cabozantinib WC) is an official document issued by a regulatory agency to a Cabozantinib manufacturer, verifying that the manufacturing facility of a Cabozantinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cabozantinib APIs or Cabozantinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Cabozantinib WC (written confirmation) as part of the regulatory process.
click here to find a list of Cabozantinib 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cabozantinib 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cabozantinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cabozantinib suppliers with NDC on PharmaCompass.
Cabozantinib 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 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 GMP manufacturer or Cabozantinib GMP API supplier for your needs.
A Cabozantinib CoA (Certificate of Analysis) is a formal document that attests to Cabozantinib's compliance with Cabozantinib specifications and serves as a tool for batch-level quality control.
Cabozantinib CoA mostly includes findings from lab analyses of a specific batch. For each Cabozantinib 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Cabozantinib EP), Cabozantinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cabozantinib USP).
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