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API SUPPLIERS
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
NDC
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USDMF
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-18
Pay. Date : 2021-01-13
DMF Number : 35433
Submission : 2021-01-04
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-08
Pay. Date : 2016-09-16
DMF Number : 30834
Submission : 2016-09-13
Status :
Type : II
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-24
Pay. Date : 2015-06-24
DMF Number : 29315
Submission : 2015-06-23
Status :
Type : II
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Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
About the Company : Farmak, A.S. is a privately held chemical and pharmaceutical company based in the Czech Republic. It specializes in researching, developing and producing active pharmaceutical ingr...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
About the Company : USV is a leading health care company with focus on Active Pharmaceutical Ingredients (marketed globally with emphasis on regulated markets of USA, European Union and Japan), Brande...
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INTERMEDIATES SUPPLIERS
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ABOUT THIS PAGE
A Regadenoson Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Regadenoson Monohydrate, including repackagers and relabelers. The FDA regulates Regadenoson Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Regadenoson 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 Regadenoson Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Regadenoson Monohydrate supplier is an individual or a company that provides Regadenoson Monohydrate active pharmaceutical ingredient (API) or Regadenoson Monohydrate finished formulations upon request. The Regadenoson Monohydrate suppliers may include Regadenoson Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Regadenoson Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Regadenoson Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Regadenoson Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Regadenoson Monohydrate DMFs exist exist since differing nations have different regulations, such as Regadenoson Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Regadenoson Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Regadenoson Monohydrate USDMF includes data on Regadenoson Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Regadenoson Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Regadenoson Monohydrate suppliers with USDMF on PharmaCompass.
A Regadenoson Monohydrate written confirmation (Regadenoson Monohydrate WC) is an official document issued by a regulatory agency to a Regadenoson Monohydrate manufacturer, verifying that the manufacturing facility of a Regadenoson Monohydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Regadenoson Monohydrate APIs or Regadenoson Monohydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Regadenoson Monohydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Regadenoson Monohydrate suppliers with Written Confirmation (WC) 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 Regadenoson Monohydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Regadenoson Monohydrate 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 Regadenoson Monohydrate 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 Regadenoson Monohydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Regadenoson Monohydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Regadenoson Monohydrate suppliers with NDC on PharmaCompass.
Regadenoson 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 Regadenoson 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 Regadenoson Monohydrate GMP manufacturer or Regadenoson Monohydrate GMP API supplier for your needs.
A Regadenoson Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Regadenoson Monohydrate's compliance with Regadenoson Monohydrate specifications and serves as a tool for batch-level quality control.
Regadenoson Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Regadenoson 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.
Regadenoson Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Regadenoson Monohydrate EP), Regadenoson Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Regadenoson Monohydrate USP).
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