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API SUPPLIERS
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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
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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...
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PharmaCompass offers a list of Regadenoson Monohydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Regadenoson Monohydrate manufacturer or Regadenoson Monohydrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Regadenoson Monohydrate manufacturer or Regadenoson Monohydrate supplier.
PharmaCompass also assists you with knowing the Regadenoson Monohydrate API Price utilized in the formulation of products. Regadenoson Monohydrate API Price is not always fixed or binding as the Regadenoson Monohydrate Price is obtained through a variety of data sources. The Regadenoson Monohydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Regadenoson manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Regadenoson, including repackagers and relabelers. The FDA regulates Regadenoson manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Regadenoson 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Regadenoson supplier is an individual or a company that provides Regadenoson active pharmaceutical ingredient (API) or Regadenoson finished formulations upon request. The Regadenoson suppliers may include Regadenoson API manufacturers, exporters, distributors and traders.
click here to find a list of Regadenoson suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Regadenoson DMF (Drug Master File) is a document detailing the whole manufacturing process of Regadenoson active pharmaceutical ingredient (API) in detail. Different forms of Regadenoson DMFs exist exist since differing nations have different regulations, such as Regadenoson USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Regadenoson DMF submitted to regulatory agencies in the US is known as a USDMF. Regadenoson USDMF includes data on Regadenoson's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Regadenoson USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Regadenoson suppliers with USDMF on PharmaCompass.
A Regadenoson written confirmation (Regadenoson WC) is an official document issued by a regulatory agency to a Regadenoson manufacturer, verifying that the manufacturing facility of a Regadenoson active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Regadenoson APIs or Regadenoson finished pharmaceutical products to another nation, regulatory agencies frequently require a Regadenoson WC (written confirmation) as part of the regulatory process.
click here to find a list of Regadenoson 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Regadenoson 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Regadenoson NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Regadenoson suppliers with NDC on PharmaCompass.
Regadenoson 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 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 GMP manufacturer or Regadenoson GMP API supplier for your needs.
A Regadenoson CoA (Certificate of Analysis) is a formal document that attests to Regadenoson's compliance with Regadenoson specifications and serves as a tool for batch-level quality control.
Regadenoson CoA mostly includes findings from lab analyses of a specific batch. For each Regadenoson 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Regadenoson EP), Regadenoson JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Regadenoson USP).
