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API SUPPLIERS
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INTERMEDIATE SUPPLIERS
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ABOUT THIS PAGE
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PharmaCompass offers a list of Epalrestat 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 Epalrestat manufacturer or Epalrestat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Epalrestat manufacturer or Epalrestat supplier.
PharmaCompass also assists you with knowing the Epalrestat API Price utilized in the formulation of products. Epalrestat API Price is not always fixed or binding as the Epalrestat Price is obtained through a variety of data sources. The Epalrestat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Aldorin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aldorin, including repackagers and relabelers. The FDA regulates Aldorin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aldorin 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 Aldorin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aldorin supplier is an individual or a company that provides Aldorin active pharmaceutical ingredient (API) or Aldorin finished formulations upon request. The Aldorin suppliers may include Aldorin API manufacturers, exporters, distributors and traders.
click here to find a list of Aldorin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Aldorin Drug Master File in Japan (Aldorin JDMF) empowers Aldorin 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 Aldorin JDMF during the approval evaluation for pharmaceutical products. At the time of Aldorin 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 Aldorin suppliers with JDMF 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 Aldorin Drug Master File in Korea (Aldorin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aldorin. The MFDS reviews the Aldorin KDMF as part of the drug registration process and uses the information provided in the Aldorin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aldorin 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 Aldorin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Aldorin suppliers with KDMF on PharmaCompass.
A Aldorin written confirmation (Aldorin WC) is an official document issued by a regulatory agency to a Aldorin manufacturer, verifying that the manufacturing facility of a Aldorin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aldorin APIs or Aldorin finished pharmaceutical products to another nation, regulatory agencies frequently require a Aldorin WC (written confirmation) as part of the regulatory process.
click here to find a list of Aldorin suppliers with Written Confirmation (WC) on PharmaCompass.
Aldorin 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 Aldorin 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 Aldorin GMP manufacturer or Aldorin GMP API supplier for your needs.
A Aldorin CoA (Certificate of Analysis) is a formal document that attests to Aldorin's compliance with Aldorin specifications and serves as a tool for batch-level quality control.
Aldorin CoA mostly includes findings from lab analyses of a specific batch. For each Aldorin 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.
Aldorin may be tested according to a variety of international standards, such as European Pharmacopoeia (Aldorin EP), Aldorin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aldorin USP).
