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ABOUT THIS PAGE
A Fasudil Hydrochloride Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fasudil Hydrochloride Hydrate, including repackagers and relabelers. The FDA regulates Fasudil Hydrochloride Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fasudil Hydrochloride 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.
A Fasudil Hydrochloride Hydrate supplier is an individual or a company that provides Fasudil Hydrochloride Hydrate active pharmaceutical ingredient (API) or Fasudil Hydrochloride Hydrate finished formulations upon request. The Fasudil Hydrochloride Hydrate suppliers may include Fasudil Hydrochloride Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Fasudil Hydrochloride Hydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fasudil Hydrochloride Hydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fasudil Hydrochloride Hydrate active pharmaceutical ingredient (API) in detail. Different forms of Fasudil Hydrochloride Hydrate DMFs exist exist since differing nations have different regulations, such as Fasudil Hydrochloride Hydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fasudil Hydrochloride Hydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Fasudil Hydrochloride Hydrate USDMF includes data on Fasudil Hydrochloride Hydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fasudil Hydrochloride Hydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fasudil Hydrochloride 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 Fasudil Hydrochloride Hydrate Drug Master File in Japan (Fasudil Hydrochloride Hydrate JDMF) empowers Fasudil Hydrochloride 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 Fasudil Hydrochloride Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Fasudil Hydrochloride 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 Fasudil Hydrochloride Hydrate suppliers with JDMF 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 Fasudil Hydrochloride Hydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fasudil Hydrochloride Hydrate 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 Fasudil Hydrochloride Hydrate 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 Fasudil Hydrochloride Hydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fasudil Hydrochloride Hydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fasudil Hydrochloride Hydrate suppliers with NDC on PharmaCompass.
Fasudil Hydrochloride 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 Fasudil Hydrochloride 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 Fasudil Hydrochloride Hydrate GMP manufacturer or Fasudil Hydrochloride Hydrate GMP API supplier for your needs.
A Fasudil Hydrochloride Hydrate CoA (Certificate of Analysis) is a formal document that attests to Fasudil Hydrochloride Hydrate's compliance with Fasudil Hydrochloride Hydrate specifications and serves as a tool for batch-level quality control.
Fasudil Hydrochloride Hydrate CoA mostly includes findings from lab analyses of a specific batch. For each Fasudil Hydrochloride 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.
Fasudil Hydrochloride Hydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Fasudil Hydrochloride Hydrate EP), Fasudil Hydrochloride Hydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fasudil Hydrochloride Hydrate USP).
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