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API SUPPLIERS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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NDC
ASMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-12
Pay. Date : 2013-01-22
DMF Number : 13383
Submission : 1998-09-01
Status :
Type : II
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
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API Imports and Exports
Drugs in Development
Lead Product(s) : Sotagliflozin,Rifampicin
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Effect of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 24, 2017
Lead Product(s) : Venetoclax,Rifampicin
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Genentech
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study to Assess the Effect of Rifampin on the Metabolism of ABT-199
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 25, 2013
Lead Product(s) : Navitoclax,Rifampicin
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study to Assess the Effect of Rifampin on the Metabolism of Navitoclax
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 12, 2010
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Capital Farma, a leading European pharmaceutical company focusing on the development & distribution of niche APIs & Pharma Services.
CAS Number : 75-64-9
End Use API : Rifampicin
About The Company : Capital Farma offers a comprehensive range of pharmaceutical solutions. Our API offering includes active ingredients sourced exclusively from top European manuf...
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REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Rifampicin 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 Rifampicin manufacturer or Rifampicin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rifampicin manufacturer or Rifampicin supplier.
PharmaCompass also assists you with knowing the Rifampicin API Price utilized in the formulation of products. Rifampicin API Price is not always fixed or binding as the Rifampicin Price is obtained through a variety of data sources. The Rifampicin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Eremfat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eremfat, including repackagers and relabelers. The FDA regulates Eremfat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eremfat 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 Eremfat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eremfat supplier is an individual or a company that provides Eremfat active pharmaceutical ingredient (API) or Eremfat finished formulations upon request. The Eremfat suppliers may include Eremfat API manufacturers, exporters, distributors and traders.
click here to find a list of Eremfat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eremfat DMF (Drug Master File) is a document detailing the whole manufacturing process of Eremfat active pharmaceutical ingredient (API) in detail. Different forms of Eremfat DMFs exist exist since differing nations have different regulations, such as Eremfat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eremfat DMF submitted to regulatory agencies in the US is known as a USDMF. Eremfat USDMF includes data on Eremfat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eremfat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eremfat 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 Eremfat Drug Master File in Japan (Eremfat JDMF) empowers Eremfat 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 Eremfat JDMF during the approval evaluation for pharmaceutical products. At the time of Eremfat 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 Eremfat suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Eremfat Drug Master File in Korea (Eremfat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eremfat. The MFDS reviews the Eremfat KDMF as part of the drug registration process and uses the information provided in the Eremfat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eremfat KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Eremfat API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eremfat suppliers with KDMF on PharmaCompass.
A Eremfat CEP of the European Pharmacopoeia monograph is often referred to as a Eremfat Certificate of Suitability (COS). The purpose of a Eremfat CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Eremfat EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Eremfat to their clients by showing that a Eremfat CEP has been issued for it. The manufacturer submits a Eremfat CEP (COS) as part of the market authorization procedure, and it takes on the role of a Eremfat CEP holder for the record. Additionally, the data presented in the Eremfat CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Eremfat DMF.
A Eremfat CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Eremfat CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Eremfat suppliers with CEP (COS) on PharmaCompass.
A Eremfat written confirmation (Eremfat WC) is an official document issued by a regulatory agency to a Eremfat manufacturer, verifying that the manufacturing facility of a Eremfat active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eremfat APIs or Eremfat finished pharmaceutical products to another nation, regulatory agencies frequently require a Eremfat WC (written confirmation) as part of the regulatory process.
click here to find a list of Eremfat 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 Eremfat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eremfat 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 Eremfat 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 Eremfat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eremfat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eremfat suppliers with NDC on PharmaCompass.
Eremfat 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 Eremfat 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 Eremfat GMP manufacturer or Eremfat GMP API supplier for your needs.
A Eremfat CoA (Certificate of Analysis) is a formal document that attests to Eremfat's compliance with Eremfat specifications and serves as a tool for batch-level quality control.
Eremfat CoA mostly includes findings from lab analyses of a specific batch. For each Eremfat 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.
Eremfat may be tested according to a variety of international standards, such as European Pharmacopoeia (Eremfat EP), Eremfat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eremfat USP).
