Synopsis
0
CEP/COS
0
EU WC
0
KDMF
0
VMF
0
Listed Suppliers
0
API
0
FDF
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
0
News #PharmaBuzz
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
ABOUT THIS PAGE
A Fasudil hydrochloride hemihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fasudil hydrochloride hemihydrate, including repackagers and relabelers. The FDA regulates Fasudil hydrochloride hemihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fasudil hydrochloride hemihydrate 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 hemihydrate supplier is an individual or a company that provides Fasudil hydrochloride hemihydrate active pharmaceutical ingredient (API) or Fasudil hydrochloride hemihydrate finished formulations upon request. The Fasudil hydrochloride hemihydrate suppliers may include Fasudil hydrochloride hemihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Fasudil hydrochloride hemihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fasudil hydrochloride hemihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Fasudil hydrochloride hemihydrate active pharmaceutical ingredient (API) in detail. Different forms of Fasudil hydrochloride hemihydrate DMFs exist exist since differing nations have different regulations, such as Fasudil hydrochloride hemihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fasudil hydrochloride hemihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Fasudil hydrochloride hemihydrate USDMF includes data on Fasudil hydrochloride hemihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fasudil hydrochloride hemihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fasudil hydrochloride hemihydrate 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 hemihydrate Drug Master File in Japan (Fasudil hydrochloride hemihydrate JDMF) empowers Fasudil hydrochloride hemihydrate 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 hemihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Fasudil hydrochloride hemihydrate 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 hemihydrate 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 hemihydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fasudil hydrochloride hemihydrate 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 hemihydrate 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 hemihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fasudil hydrochloride hemihydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fasudil hydrochloride hemihydrate suppliers with NDC on PharmaCompass.
Fasudil hydrochloride hemihydrate 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 hemihydrate 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 hemihydrate GMP manufacturer or Fasudil hydrochloride hemihydrate GMP API supplier for your needs.
A Fasudil hydrochloride hemihydrate CoA (Certificate of Analysis) is a formal document that attests to Fasudil hydrochloride hemihydrate's compliance with Fasudil hydrochloride hemihydrate specifications and serves as a tool for batch-level quality control.
Fasudil hydrochloride hemihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Fasudil hydrochloride hemihydrate 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 hemihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Fasudil hydrochloride hemihydrate EP), Fasudil hydrochloride hemihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fasudil hydrochloride hemihydrate USP).
LOOKING FOR A SUPPLIER?
