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DOSAGE - SOLUTION;INTRAVENOUS - EQ 200MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
USFDA APPLICATION NUMBER - 22225
DOSAGE - SOLUTION;INTRAVENOUS - EQ 500MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
USFDA APPLICATION NUMBER - 22225
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PharmaCompass offers a list of Sugammadex Sodium 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 Sugammadex Sodium manufacturer or Sugammadex Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sugammadex Sodium manufacturer or Sugammadex Sodium supplier.
PharmaCompass also assists you with knowing the Sugammadex Sodium API Price utilized in the formulation of products. Sugammadex Sodium API Price is not always fixed or binding as the Sugammadex Sodium Price is obtained through a variety of data sources. The Sugammadex Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sugammadex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sugammadex, including repackagers and relabelers. The FDA regulates Sugammadex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sugammadex 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 Sugammadex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sugammadex supplier is an individual or a company that provides Sugammadex active pharmaceutical ingredient (API) or Sugammadex finished formulations upon request. The Sugammadex suppliers may include Sugammadex API manufacturers, exporters, distributors and traders.
click here to find a list of Sugammadex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sugammadex DMF (Drug Master File) is a document detailing the whole manufacturing process of Sugammadex active pharmaceutical ingredient (API) in detail. Different forms of Sugammadex DMFs exist exist since differing nations have different regulations, such as Sugammadex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sugammadex DMF submitted to regulatory agencies in the US is known as a USDMF. Sugammadex USDMF includes data on Sugammadex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sugammadex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sugammadex 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 Sugammadex Drug Master File in Japan (Sugammadex JDMF) empowers Sugammadex 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 Sugammadex JDMF during the approval evaluation for pharmaceutical products. At the time of Sugammadex 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 Sugammadex 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 Sugammadex Drug Master File in Korea (Sugammadex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sugammadex. The MFDS reviews the Sugammadex KDMF as part of the drug registration process and uses the information provided in the Sugammadex KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sugammadex 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 Sugammadex API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sugammadex suppliers with KDMF on PharmaCompass.
A Sugammadex written confirmation (Sugammadex WC) is an official document issued by a regulatory agency to a Sugammadex manufacturer, verifying that the manufacturing facility of a Sugammadex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sugammadex APIs or Sugammadex finished pharmaceutical products to another nation, regulatory agencies frequently require a Sugammadex WC (written confirmation) as part of the regulatory process.
click here to find a list of Sugammadex 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 Sugammadex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sugammadex 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 Sugammadex 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 Sugammadex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sugammadex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sugammadex suppliers with NDC on PharmaCompass.
Sugammadex 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 Sugammadex 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 Sugammadex GMP manufacturer or Sugammadex GMP API supplier for your needs.
A Sugammadex CoA (Certificate of Analysis) is a formal document that attests to Sugammadex's compliance with Sugammadex specifications and serves as a tool for batch-level quality control.
Sugammadex CoA mostly includes findings from lab analyses of a specific batch. For each Sugammadex 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.
Sugammadex may be tested according to a variety of international standards, such as European Pharmacopoeia (Sugammadex EP), Sugammadex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sugammadex USP).
