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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- INJECTABLE;INTRAVENOUS - 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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PharmaCompass offers a list of Argatroban 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 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.
PharmaCompass also assists you with knowing the Argatroban API Price utilized in the formulation of products. Argatroban API Price is not always fixed or binding as the Argatroban Price is obtained through a variety of data sources. The Argatroban Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ARGATROBAN IN 0.9% SODIUM CHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ARGATROBAN IN 0.9% SODIUM CHLORIDE, including repackagers and relabelers. The FDA regulates ARGATROBAN IN 0.9% SODIUM CHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ARGATROBAN IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ARGATROBAN IN 0.9% SODIUM CHLORIDE supplier is an individual or a company that provides ARGATROBAN IN 0.9% SODIUM CHLORIDE active pharmaceutical ingredient (API) or ARGATROBAN IN 0.9% SODIUM CHLORIDE finished formulations upon request. The ARGATROBAN IN 0.9% SODIUM CHLORIDE suppliers may include ARGATROBAN IN 0.9% SODIUM CHLORIDE API manufacturers, exporters, distributors and traders.
click here to find a list of ARGATROBAN IN 0.9% SODIUM CHLORIDE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ARGATROBAN IN 0.9% SODIUM CHLORIDE DMF (Drug Master File) is a document detailing the whole manufacturing process of ARGATROBAN IN 0.9% SODIUM CHLORIDE active pharmaceutical ingredient (API) in detail. Different forms of ARGATROBAN IN 0.9% SODIUM CHLORIDE DMFs exist exist since differing nations have different regulations, such as ARGATROBAN IN 0.9% SODIUM CHLORIDE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ARGATROBAN IN 0.9% SODIUM CHLORIDE DMF submitted to regulatory agencies in the US is known as a USDMF. ARGATROBAN IN 0.9% SODIUM CHLORIDE USDMF includes data on ARGATROBAN IN 0.9% SODIUM CHLORIDE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ARGATROBAN IN 0.9% SODIUM CHLORIDE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ARGATROBAN IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE Drug Master File in Japan (ARGATROBAN IN 0.9% SODIUM CHLORIDE JDMF) empowers ARGATROBAN IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE JDMF during the approval evaluation for pharmaceutical products. At the time of ARGATROBAN IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE Drug Master File in Korea (ARGATROBAN IN 0.9% SODIUM CHLORIDE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ARGATROBAN IN 0.9% SODIUM CHLORIDE. The MFDS reviews the ARGATROBAN IN 0.9% SODIUM CHLORIDE KDMF as part of the drug registration process and uses the information provided in the ARGATROBAN IN 0.9% SODIUM CHLORIDE KDMF to evaluate the safety and efficacy of the drug.
After submitting a ARGATROBAN IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ARGATROBAN IN 0.9% SODIUM CHLORIDE suppliers with KDMF on PharmaCompass.
A ARGATROBAN IN 0.9% SODIUM CHLORIDE written confirmation (ARGATROBAN IN 0.9% SODIUM CHLORIDE WC) is an official document issued by a regulatory agency to a ARGATROBAN IN 0.9% SODIUM CHLORIDE manufacturer, verifying that the manufacturing facility of a ARGATROBAN IN 0.9% SODIUM CHLORIDE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ARGATROBAN IN 0.9% SODIUM CHLORIDE APIs or ARGATROBAN IN 0.9% SODIUM CHLORIDE finished pharmaceutical products to another nation, regulatory agencies frequently require a ARGATROBAN IN 0.9% SODIUM CHLORIDE WC (written confirmation) as part of the regulatory process.
click here to find a list of ARGATROBAN IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ARGATROBAN IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ARGATROBAN IN 0.9% SODIUM CHLORIDE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ARGATROBAN IN 0.9% SODIUM CHLORIDE suppliers with NDC on PharmaCompass.
ARGATROBAN IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE GMP manufacturer or ARGATROBAN IN 0.9% SODIUM CHLORIDE GMP API supplier for your needs.
A ARGATROBAN IN 0.9% SODIUM CHLORIDE CoA (Certificate of Analysis) is a formal document that attests to ARGATROBAN IN 0.9% SODIUM CHLORIDE's compliance with ARGATROBAN IN 0.9% SODIUM CHLORIDE specifications and serves as a tool for batch-level quality control.
ARGATROBAN IN 0.9% SODIUM CHLORIDE CoA mostly includes findings from lab analyses of a specific batch. For each ARGATROBAN IN 0.9% SODIUM CHLORIDE 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 IN 0.9% SODIUM CHLORIDE may be tested according to a variety of international standards, such as European Pharmacopoeia (ARGATROBAN IN 0.9% SODIUM CHLORIDE EP), ARGATROBAN IN 0.9% SODIUM CHLORIDE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ARGATROBAN IN 0.9% SODIUM CHLORIDE USP).
