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ABOUT THIS PAGE
A Sivelestat Sodium Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sivelestat Sodium Hydrate, including repackagers and relabelers. The FDA regulates Sivelestat Sodium Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sivelestat Sodium Hydrate 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 Sivelestat Sodium Hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sivelestat Sodium Hydrate supplier is an individual or a company that provides Sivelestat Sodium Hydrate active pharmaceutical ingredient (API) or Sivelestat Sodium Hydrate finished formulations upon request. The Sivelestat Sodium Hydrate suppliers may include Sivelestat Sodium Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sivelestat Sodium Hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sivelestat Sodium Hydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sivelestat Sodium Hydrate active pharmaceutical ingredient (API) in detail. Different forms of Sivelestat Sodium Hydrate DMFs exist exist since differing nations have different regulations, such as Sivelestat Sodium Hydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sivelestat Sodium Hydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sivelestat Sodium Hydrate USDMF includes data on Sivelestat Sodium Hydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sivelestat Sodium Hydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sivelestat Sodium Hydrate 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 Sivelestat Sodium Hydrate Drug Master File in Japan (Sivelestat Sodium Hydrate JDMF) empowers Sivelestat Sodium Hydrate 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 Sivelestat Sodium Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Sivelestat Sodium Hydrate 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 Sivelestat Sodium Hydrate suppliers with JDMF on PharmaCompass.
Sivelestat Sodium Hydrate 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 Sivelestat Sodium Hydrate 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 Sivelestat Sodium Hydrate GMP manufacturer or Sivelestat Sodium Hydrate GMP API supplier for your needs.
A Sivelestat Sodium Hydrate CoA (Certificate of Analysis) is a formal document that attests to Sivelestat Sodium Hydrate's compliance with Sivelestat Sodium Hydrate specifications and serves as a tool for batch-level quality control.
Sivelestat Sodium Hydrate CoA mostly includes findings from lab analyses of a specific batch. For each Sivelestat Sodium Hydrate 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.
Sivelestat Sodium Hydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sivelestat Sodium Hydrate EP), Sivelestat Sodium Hydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sivelestat Sodium Hydrate USP).
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