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API SUPPLIERS
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Pfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.
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NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Ganaxolone
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Marinus Pharmaceuticals
Deal Size : $1.5 million
Deal Type : Termination
Orion and Marinus Terminate Agreement for Ganaxolone in Europe
Details : under the termination agreement, Marinus regains Ztalmy (ganaxolone) rights in Europe. It is approved for the adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder.
Product Name : Ztalmy
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
December 30, 2024
Lead Product(s) : Ganaxolone
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Marinus Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ztalmy (ganaxolone) is a positive allosteric modulation of the gamma-aminobutyric acid type A (GABAA) receptor in the CNS. It is used for the treatment of epileptic seizures associated with CDKL5 deficiency disorder.
Product Name : Ztalmy
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 31, 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ganaxolone 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 Ganaxolone manufacturer or Ganaxolone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ganaxolone manufacturer or Ganaxolone supplier.
PharmaCompass also assists you with knowing the Ganaxolone API Price utilized in the formulation of products. Ganaxolone API Price is not always fixed or binding as the Ganaxolone Price is obtained through a variety of data sources. The Ganaxolone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ganaxolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ganaxolone, including repackagers and relabelers. The FDA regulates Ganaxolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ganaxolone 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 Ganaxolone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ganaxolone supplier is an individual or a company that provides Ganaxolone active pharmaceutical ingredient (API) or Ganaxolone finished formulations upon request. The Ganaxolone suppliers may include Ganaxolone API manufacturers, exporters, distributors and traders.
click here to find a list of Ganaxolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Ganaxolone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ganaxolone 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 Ganaxolone 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 Ganaxolone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ganaxolone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ganaxolone suppliers with NDC on PharmaCompass.
Ganaxolone 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 Ganaxolone 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 Ganaxolone GMP manufacturer or Ganaxolone GMP API supplier for your needs.
A Ganaxolone CoA (Certificate of Analysis) is a formal document that attests to Ganaxolone's compliance with Ganaxolone specifications and serves as a tool for batch-level quality control.
Ganaxolone CoA mostly includes findings from lab analyses of a specific batch. For each Ganaxolone 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.
Ganaxolone may be tested according to a variety of international standards, such as European Pharmacopoeia (Ganaxolone EP), Ganaxolone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ganaxolone USP).
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