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API SUPPLIERS
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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
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Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...
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 one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...
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-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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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, Price,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.
PharmaCompass also assists you with knowing the Daprodustat API Price utilized in the formulation of products. Daprodustat API Price is not always fixed or binding as the Daprodustat Price is obtained through a variety of data sources. The Daprodustat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Daprodustat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daprodustat, including repackagers and relabelers. The FDA regulates Daprodustat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daprodustat 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 Daprodustat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Daprodustat supplier is an individual or a company that provides Daprodustat active pharmaceutical ingredient (API) or Daprodustat finished formulations upon request. The Daprodustat suppliers may include Daprodustat API manufacturers, exporters, distributors and traders.
click here to find a list of Daprodustat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Daprodustat DMF (Drug Master File) is a document detailing the whole manufacturing process of Daprodustat active pharmaceutical ingredient (API) in detail. Different forms of Daprodustat DMFs exist exist since differing nations have different regulations, such as Daprodustat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Daprodustat DMF submitted to regulatory agencies in the US is known as a USDMF. Daprodustat USDMF includes data on Daprodustat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Daprodustat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Daprodustat suppliers with USDMF 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 Daprodustat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Daprodustat 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 Daprodustat 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 Daprodustat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Daprodustat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Daprodustat suppliers with NDC on PharmaCompass.
Daprodustat 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 Daprodustat 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 Daprodustat GMP manufacturer or Daprodustat GMP API supplier for your needs.
A Daprodustat CoA (Certificate of Analysis) is a formal document that attests to Daprodustat's compliance with Daprodustat specifications and serves as a tool for batch-level quality control.
Daprodustat CoA mostly includes findings from lab analyses of a specific batch. For each Daprodustat 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.
Daprodustat may be tested according to a variety of international standards, such as European Pharmacopoeia (Daprodustat EP), Daprodustat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Daprodustat USP).
