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**Fe...DOSAGE - INJECTABLE;INJECTION - 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Fed...DOSAGE - INJECTABLE;INJECTION - 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Fed...DOSAGE - INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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