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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 : 38516
Submission : 2023-06-30
Status :
Type : II
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43321
Submission : 2025-12-23
Status :
Type : II
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Suanfarma, at the Core of a Better Life.
About the Company : Suanfarma is a B2B life sciences company focused on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an innovative and sustai...
Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory thera...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical is a wholly owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Located in the Qihe Economic Development Zone, Sh...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
Lewens Labs transforms healthcare with innovative, sustainable, and affordable pharmaceutical solutions worldwide.
About the Company : Lewens Labs was established with a vision to transform the pharmaceutical industry, inspired by an award-winning engineering project that reduced the cost of Aceclofenac and receiv...
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PharmaCompass offers a list of Daprodustat API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Daprodustat manufacturer or Daprodustat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Daprodustat manufacturer or Daprodustat supplier.
A 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid, including repackagers and relabelers. The FDA regulates 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid 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 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid supplier is an individual or a company that provides 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid active pharmaceutical ingredient (API) or 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid finished formulations upon request. The 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid suppliers may include 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid API manufacturers, exporters, distributors and traders.
click here to find a list of 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid active pharmaceutical ingredient (API) in detail. Different forms of 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid DMFs exist exist since differing nations have different regulations, such as 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid DMF submitted to regulatory agencies in the US is known as a USDMF. 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid USDMF includes data on 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid suppliers with USDMF on PharmaCompass.
A 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid written confirmation (2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid WC) is an official document issued by a regulatory agency to a 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid manufacturer, verifying that the manufacturing facility of a 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid APIs or 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid finished pharmaceutical products to another nation, regulatory agencies frequently require a 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid WC (written confirmation) as part of the regulatory process.
click here to find a list of 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid 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 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid 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 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid 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 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid suppliers with NDC on PharmaCompass.
2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid 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 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid GMP manufacturer or 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid GMP API supplier for your needs.
A 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid CoA (Certificate of Analysis) is a formal document that attests to 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid's compliance with 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid specifications and serves as a tool for batch-level quality control.
2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid CoA mostly includes findings from lab analyses of a specific batch. For each 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid 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.
2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid may be tested according to a variety of international standards, such as European Pharmacopoeia (2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid EP), 2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (2-[(1,3-dicyclohexyl-2,4,6-trioxo-1,3-diazinane-5-carbonyl)amino]acetic acid USP).
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