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Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Date of Issue : 2025-07-17
Valid Till : 2028-08-26
Written Confirmation Number : SD250073
Address of the Firm : No. 127, Qizhong Avenue, Qihe County, Dezhou City, Shandong Province, China
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Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
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...
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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ABOUT THIS PAGE
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PharmaCompass offers a list of Dotinurad 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 Dotinurad manufacturer or Dotinurad supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dotinurad manufacturer or Dotinurad supplier.
PharmaCompass also assists you with knowing the Dotinurad API Price utilized in the formulation of products. Dotinurad API Price is not always fixed or binding as the Dotinurad Price is obtained through a variety of data sources. The Dotinurad Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dotinurad manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dotinurad, including repackagers and relabelers. The FDA regulates Dotinurad manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dotinurad 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 Dotinurad manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dotinurad supplier is an individual or a company that provides Dotinurad active pharmaceutical ingredient (API) or Dotinurad finished formulations upon request. The Dotinurad suppliers may include Dotinurad API manufacturers, exporters, distributors and traders.
click here to find a list of Dotinurad suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dotinurad DMF (Drug Master File) is a document detailing the whole manufacturing process of Dotinurad active pharmaceutical ingredient (API) in detail. Different forms of Dotinurad DMFs exist exist since differing nations have different regulations, such as Dotinurad USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dotinurad DMF submitted to regulatory agencies in the US is known as a USDMF. Dotinurad USDMF includes data on Dotinurad's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dotinurad USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dotinurad suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Dotinurad Drug Master File in Japan (Dotinurad JDMF) empowers Dotinurad API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Dotinurad JDMF during the approval evaluation for pharmaceutical products. At the time of Dotinurad JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Dotinurad suppliers with JDMF on PharmaCompass.
A Dotinurad written confirmation (Dotinurad WC) is an official document issued by a regulatory agency to a Dotinurad manufacturer, verifying that the manufacturing facility of a Dotinurad active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dotinurad APIs or Dotinurad finished pharmaceutical products to another nation, regulatory agencies frequently require a Dotinurad WC (written confirmation) as part of the regulatory process.
click here to find a list of Dotinurad suppliers with Written Confirmation (WC) on PharmaCompass.
Dotinurad 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 Dotinurad 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 Dotinurad GMP manufacturer or Dotinurad GMP API supplier for your needs.
A Dotinurad CoA (Certificate of Analysis) is a formal document that attests to Dotinurad's compliance with Dotinurad specifications and serves as a tool for batch-level quality control.
Dotinurad CoA mostly includes findings from lab analyses of a specific batch. For each Dotinurad 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.
Dotinurad may be tested according to a variety of international standards, such as European Pharmacopoeia (Dotinurad EP), Dotinurad JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dotinurad USP).
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