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API SUPPLIERS
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USDMF
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-18
Pay. Date : 2013-10-25
DMF Number : 20760
Submission : 2007-08-07
Status :
Type : II
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Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expe...
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DOSAGE - INJECTABLE;INJECTION - 250MG/2.5ML (...DOSAGE - INJECTABLE;INJECTION - 250MG/2.5ML (100MG/ML)
USFDA APPLICATION NUMBER - 203049
DOSAGE - INJECTABLE;INJECTION - 50MG/50ML (1M...DOSAGE - INJECTABLE;INJECTION - 50MG/50ML (1MG/ML)
USFDA APPLICATION NUMBER - 203049
DOSAGE - INJECTABLE;INJECTION - 250MG/2.5ML (...DOSAGE - INJECTABLE;INJECTION - 250MG/2.5ML (100MG/ML)
USFDA APPLICATION NUMBER - 20883
DOSAGE - INJECTABLE;INTRAVENOUS - 50MG/50ML (...DOSAGE - INJECTABLE;INTRAVENOUS - 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22434
DOSAGE - INJECTABLE;INTRAVENOUS - 125MG/125ML...DOSAGE - INJECTABLE;INTRAVENOUS - 125MG/125ML (1MG/ML)
USFDA APPLICATION NUMBER - 22485
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ABOUT THIS PAGE
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PharmaCompass offers a list of Argatroban API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Argatroban manufacturer or Argatroban supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Argatroban manufacturer or Argatroban supplier.
A Argatroban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Argatroban, including repackagers and relabelers. The FDA regulates Argatroban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Argatroban 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Argatroban supplier is an individual or a company that provides Argatroban active pharmaceutical ingredient (API) or Argatroban finished formulations upon request. The Argatroban suppliers may include Argatroban API manufacturers, exporters, distributors and traders.
click here to find a list of Argatroban suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Argatroban DMF (Drug Master File) is a document detailing the whole manufacturing process of Argatroban active pharmaceutical ingredient (API) in detail. Different forms of Argatroban DMFs exist exist since differing nations have different regulations, such as Argatroban USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Argatroban DMF submitted to regulatory agencies in the US is known as a USDMF. Argatroban USDMF includes data on Argatroban's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Argatroban USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Argatroban 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 Drug Master File in Japan (Argatroban JDMF) empowers Argatroban 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Argatroban 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 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 Argatroban Drug Master File in Korea (Argatroban KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Argatroban. The MFDS reviews the Argatroban KDMF as part of the drug registration process and uses the information provided in the Argatroban KDMF to evaluate the safety and efficacy of the drug.
After submitting a Argatroban 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 Argatroban API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Argatroban suppliers with KDMF on PharmaCompass.
A Argatroban written confirmation (Argatroban WC) is an official document issued by a regulatory agency to a Argatroban manufacturer, verifying that the manufacturing facility of a Argatroban active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Argatroban APIs or Argatroban finished pharmaceutical products to another nation, regulatory agencies frequently require a Argatroban WC (written confirmation) as part of the regulatory process.
click here to find a list of Argatroban 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 Argatroban as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Argatroban 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 Argatroban 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 Argatroban and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Argatroban NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Argatroban suppliers with NDC on PharmaCompass.
Argatroban 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 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Argatroban GMP manufacturer or Argatroban GMP API supplier for your needs.
A Argatroban CoA (Certificate of Analysis) is a formal document that attests to Argatroban's compliance with Argatroban specifications and serves as a tool for batch-level quality control.
Argatroban CoA mostly includes findings from lab analyses of a specific batch. For each Argatroban 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Argatroban EP), Argatroban JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Argatroban USP).
