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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Dantrium vial 20mg
Dosage Form : INJ
Dosage Strength : 20mg
Packaging : 12X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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DOSAGE - CAPSULE;ORAL - 100MG
USFDA APPLICATION NUMBER - 17443
DOSAGE - CAPSULE;ORAL - 25MG
USFDA APPLICATION NUMBER - 17443
DOSAGE - CAPSULE;ORAL - 50MG
USFDA APPLICATION NUMBER - 17443
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ABOUT THIS PAGE
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PharmaCompass offers a list of Dantrolene 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 Dantrolene manufacturer or Dantrolene supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dantrolene manufacturer or Dantrolene supplier.
PharmaCompass also assists you with knowing the Dantrolene API Price utilized in the formulation of products. Dantrolene API Price is not always fixed or binding as the Dantrolene Price is obtained through a variety of data sources. The Dantrolene Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dantrolene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dantrolene, including repackagers and relabelers. The FDA regulates Dantrolene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dantrolene 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 Dantrolene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dantrolene supplier is an individual or a company that provides Dantrolene active pharmaceutical ingredient (API) or Dantrolene finished formulations upon request. The Dantrolene suppliers may include Dantrolene API manufacturers, exporters, distributors and traders.
click here to find a list of Dantrolene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dantrolene DMF (Drug Master File) is a document detailing the whole manufacturing process of Dantrolene active pharmaceutical ingredient (API) in detail. Different forms of Dantrolene DMFs exist exist since differing nations have different regulations, such as Dantrolene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dantrolene DMF submitted to regulatory agencies in the US is known as a USDMF. Dantrolene USDMF includes data on Dantrolene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dantrolene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dantrolene suppliers with USDMF 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 Dantrolene as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dantrolene 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 Dantrolene 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 Dantrolene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dantrolene NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dantrolene suppliers with NDC on PharmaCompass.
Dantrolene 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 Dantrolene 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 Dantrolene GMP manufacturer or Dantrolene GMP API supplier for your needs.
A Dantrolene CoA (Certificate of Analysis) is a formal document that attests to Dantrolene's compliance with Dantrolene specifications and serves as a tool for batch-level quality control.
Dantrolene CoA mostly includes findings from lab analyses of a specific batch. For each Dantrolene 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.
Dantrolene may be tested according to a variety of international standards, such as European Pharmacopoeia (Dantrolene EP), Dantrolene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dantrolene USP).
