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**Fe...DOSAGE - INJECTABLE;INJECTION - 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Fed...DOSAGE - INJECTABLE;INJECTION - 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Fed...DOSAGE - INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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