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- INJECTABLE;INTRAVENOUS - 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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