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API SUPPLIERS
AMI Lifesciences is Driven by Chemistry. Powered by People.
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
NDC
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
ASolution Pharmaceuticals: Your CDMO Partner for APIs and Specialty Molecules.
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USDMF
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38201
Submission : 2023-03-24
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37896
Submission : 2022-12-23
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-13
Pay. Date : 2017-12-29
DMF Number : 32401
Submission : 2018-02-06
Status :
Type : II
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China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
tert-butyl (1R,2S,5S)-2-aMino-5-(diMethylcarbaMoyl...
CAS Number : 365998-36-3
End Use API : Edoxaban Tosylate
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
tert-Butyl [(1R,2S,5S)-2-amino-5-[(dimethylamino)c...
CAS Number : 1210348-34-7
End Use API : Edoxaban Tosylate
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
2-bromo-5-methyl-6,7-dihydro-4H-[1,3]thiazolo[5,4-...
CAS Number : 852291-42-0
End Use API : Edoxaban Tosylate
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
(1S,4S,5S)-4-Bromo-6-oxabicyclo[3.2.1]octan-7-one
CAS Number : 139893-81-5
End Use API : Edoxaban Tosylate
About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experie...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
5-Methyl-4,5,6,7-tetrahydrothiazolo[5,4-c] pyridin...
CAS Number : 720720-96-7
End Use API : Edoxaban Tosylate
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
tert-Butyl [(1R,2S,5S)-2-Amino-5-[(dimethylamino) ...
CAS Number : 365998-36-3
End Use API : Edoxaban Tosylate
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Ethyl 2-((5-chloropyridin-2-yl) amino)-2-oxoacetat...
CAS Number : 1243308-37-3
End Use API : Edoxaban Tosylate
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
tert-Butyl [(1R,2S,5S)-2- amino-5- [(dimethylamino...
CAS Number : 1210348-34-7
End Use API : Edoxaban Tosylate
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
5-Methyl-4,5,6,7- tetrahydrothiazolo[5,4- c]pyridi...
CAS Number : 720720-96-7
End Use API : Edoxaban Tosylate
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
2-[(5-Chloropyridin-2- yl)amino]-2-oxoacetic acid ...
CAS Number : 1243308-37-3
End Use API : Edoxaban Tosylate
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
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PharmaCompass offers a list of Edoxaban Tosylate 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 Edoxaban Tosylate manufacturer or Edoxaban Tosylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Edoxaban Tosylate manufacturer or Edoxaban Tosylate supplier.
PharmaCompass also assists you with knowing the Edoxaban Tosylate API Price utilized in the formulation of products. Edoxaban Tosylate API Price is not always fixed or binding as the Edoxaban Tosylate Price is obtained through a variety of data sources. The Edoxaban Tosylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Edoxaban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Edoxaban, including repackagers and relabelers. The FDA regulates Edoxaban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Edoxaban 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 Edoxaban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Edoxaban supplier is an individual or a company that provides Edoxaban active pharmaceutical ingredient (API) or Edoxaban finished formulations upon request. The Edoxaban suppliers may include Edoxaban API manufacturers, exporters, distributors and traders.
click here to find a list of Edoxaban suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Edoxaban DMF (Drug Master File) is a document detailing the whole manufacturing process of Edoxaban active pharmaceutical ingredient (API) in detail. Different forms of Edoxaban DMFs exist exist since differing nations have different regulations, such as Edoxaban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Edoxaban DMF submitted to regulatory agencies in the US is known as a USDMF. Edoxaban USDMF includes data on Edoxaban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Edoxaban USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Edoxaban 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 Edoxaban Drug Master File in Korea (Edoxaban KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Edoxaban. The MFDS reviews the Edoxaban KDMF as part of the drug registration process and uses the information provided in the Edoxaban KDMF to evaluate the safety and efficacy of the drug.
After submitting a Edoxaban 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 Edoxaban API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Edoxaban suppliers with KDMF on PharmaCompass.
A Edoxaban written confirmation (Edoxaban WC) is an official document issued by a regulatory agency to a Edoxaban manufacturer, verifying that the manufacturing facility of a Edoxaban active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Edoxaban APIs or Edoxaban finished pharmaceutical products to another nation, regulatory agencies frequently require a Edoxaban WC (written confirmation) as part of the regulatory process.
click here to find a list of Edoxaban 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 Edoxaban as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Edoxaban 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 Edoxaban 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 Edoxaban and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Edoxaban NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Edoxaban suppliers with NDC on PharmaCompass.
Edoxaban 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 Edoxaban 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 Edoxaban GMP manufacturer or Edoxaban GMP API supplier for your needs.
A Edoxaban CoA (Certificate of Analysis) is a formal document that attests to Edoxaban's compliance with Edoxaban specifications and serves as a tool for batch-level quality control.
Edoxaban CoA mostly includes findings from lab analyses of a specific batch. For each Edoxaban 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.
Edoxaban may be tested according to a variety of international standards, such as European Pharmacopoeia (Edoxaban EP), Edoxaban JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Edoxaban USP).
