Synopsis
0
CEP/COS
0
KDMF
0
NDC API
0
VMF
0
FDF
0
FDA Orange Book
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
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
0
News #PharmaBuzz
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Click Us!
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-27
Pay. Date : 2019-12-20
DMF Number : 20709
Submission : 2007-07-20
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
Market Place
ABOUT THIS PAGE
A Argatroban Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Argatroban Monohydrate, including repackagers and relabelers. The FDA regulates Argatroban Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Argatroban Monohydrate 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 Argatroban Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Argatroban Monohydrate supplier is an individual or a company that provides Argatroban Monohydrate active pharmaceutical ingredient (API) or Argatroban Monohydrate finished formulations upon request. The Argatroban Monohydrate suppliers may include Argatroban Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Argatroban Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Argatroban Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Argatroban Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Argatroban Monohydrate DMFs exist exist since differing nations have different regulations, such as Argatroban Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Argatroban Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Argatroban Monohydrate USDMF includes data on Argatroban Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Argatroban Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Argatroban Monohydrate 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 Argatroban Monohydrate Drug Master File in Japan (Argatroban Monohydrate JDMF) empowers Argatroban Monohydrate 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 Argatroban Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Argatroban Monohydrate 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 Argatroban Monohydrate suppliers with JDMF on PharmaCompass.
A Argatroban Monohydrate written confirmation (Argatroban Monohydrate WC) is an official document issued by a regulatory agency to a Argatroban Monohydrate manufacturer, verifying that the manufacturing facility of a Argatroban Monohydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Argatroban Monohydrate APIs or Argatroban Monohydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Argatroban Monohydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Argatroban Monohydrate suppliers with Written Confirmation (WC) on PharmaCompass.
Argatroban Monohydrate 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 Argatroban Monohydrate 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 Argatroban Monohydrate GMP manufacturer or Argatroban Monohydrate GMP API supplier for your needs.
A Argatroban Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Argatroban Monohydrate's compliance with Argatroban Monohydrate specifications and serves as a tool for batch-level quality control.
Argatroban Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Argatroban Monohydrate 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.
Argatroban Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Argatroban Monohydrate EP), Argatroban Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Argatroban Monohydrate USP).
LOOKING FOR A SUPPLIER?
