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DOSAGE - INJECTABLE;INJECTION - 20MG/ML
USFDA APPLICATION NUMBER - 8453
DOSAGE - INJECTABLE;INJECTION - 100MG/ML **Fe...DOSAGE - INJECTABLE;INJECTION - 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 8845
DOSAGE - INJECTABLE;INJECTION - 20MG/ML **Fed...DOSAGE - INJECTABLE;INJECTION - 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 8845
DOSAGE - INJECTABLE;INJECTION - 50MG/ML **Fed...DOSAGE - INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 8845
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PharmaCompass offers a list of Succinylcholine Chloride 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 Succinylcholine Chloride manufacturer or Succinylcholine Chloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Succinylcholine Chloride manufacturer or Succinylcholine Chloride supplier.
PharmaCompass also assists you with knowing the Succinylcholine Chloride API Price utilized in the formulation of products. Succinylcholine Chloride API Price is not always fixed or binding as the Succinylcholine Chloride Price is obtained through a variety of data sources. The Succinylcholine Chloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Succinylcholine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Succinylcholine, including repackagers and relabelers. The FDA regulates Succinylcholine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Succinylcholine 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 Succinylcholine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Succinylcholine supplier is an individual or a company that provides Succinylcholine active pharmaceutical ingredient (API) or Succinylcholine finished formulations upon request. The Succinylcholine suppliers may include Succinylcholine API manufacturers, exporters, distributors and traders.
click here to find a list of Succinylcholine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Succinylcholine DMF (Drug Master File) is a document detailing the whole manufacturing process of Succinylcholine active pharmaceutical ingredient (API) in detail. Different forms of Succinylcholine DMFs exist exist since differing nations have different regulations, such as Succinylcholine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Succinylcholine DMF submitted to regulatory agencies in the US is known as a USDMF. Succinylcholine USDMF includes data on Succinylcholine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Succinylcholine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Succinylcholine 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 Succinylcholine Drug Master File in Japan (Succinylcholine JDMF) empowers Succinylcholine 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 Succinylcholine JDMF during the approval evaluation for pharmaceutical products. At the time of Succinylcholine 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 Succinylcholine suppliers with JDMF on PharmaCompass.
A Succinylcholine CEP of the European Pharmacopoeia monograph is often referred to as a Succinylcholine Certificate of Suitability (COS). The purpose of a Succinylcholine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Succinylcholine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Succinylcholine to their clients by showing that a Succinylcholine CEP has been issued for it. The manufacturer submits a Succinylcholine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Succinylcholine CEP holder for the record. Additionally, the data presented in the Succinylcholine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Succinylcholine DMF.
A Succinylcholine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Succinylcholine 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 Succinylcholine suppliers with CEP (COS) on PharmaCompass.
A Succinylcholine written confirmation (Succinylcholine WC) is an official document issued by a regulatory agency to a Succinylcholine manufacturer, verifying that the manufacturing facility of a Succinylcholine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Succinylcholine APIs or Succinylcholine finished pharmaceutical products to another nation, regulatory agencies frequently require a Succinylcholine WC (written confirmation) as part of the regulatory process.
click here to find a list of Succinylcholine 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 Succinylcholine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Succinylcholine 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 Succinylcholine 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 Succinylcholine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Succinylcholine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Succinylcholine suppliers with NDC on PharmaCompass.
Succinylcholine 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 Succinylcholine 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 Succinylcholine GMP manufacturer or Succinylcholine GMP API supplier for your needs.
A Succinylcholine CoA (Certificate of Analysis) is a formal document that attests to Succinylcholine's compliance with Succinylcholine specifications and serves as a tool for batch-level quality control.
Succinylcholine CoA mostly includes findings from lab analyses of a specific batch. For each Succinylcholine 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.
Succinylcholine may be tested according to a variety of international standards, such as European Pharmacopoeia (Succinylcholine EP), Succinylcholine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Succinylcholine USP).
