Synopsis
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1. 3,4 Diaminopyridine
2. 3,4-diaminopyridine
3. Amifampridine
4. Firdapse
5. Ruzurgi
1. Zenas
2. 3,4-diaminopyridine Phosphate
3. 446254-47-3
4. Firdapse (tn)
5. Amifampridine Phosphate [mi]
6. 3,4-pyridinediamine, Phosphate (1:1)
7. Amifampridine Phosphate [usan]
8. Amifampridine Phosphate [mart.]
9. Amifampridine Phosphate [who-dd]
10. 446254-47-3 (phosphate)
11. Amifampridine (phosphate)
12. Amifampridine Phosphate [ema Epar]
13. 3,4-dapp
14. 8hf8fin815
15. Pyridine-3,4-diamine Phosphate
16. Amifampridine Phosphate (usan)
17. Unii-8hf8fin815
18. Phosphoric Acid;pyridine-3,4-diamine
19. Starbld0005260
20. Schembl3958357
21. Chembl3301611
22. Dtxsid40196254
23. Hy-14946a
24. Amifampridine Phosphate [orange Book]
25. Cs-0009524
26. 3,4-diaminopyridin-1-ium Dihydrogen Phosphate
27. D10689
28. Q27270515
Molecular Weight | 207.12 g/mol |
---|---|
Molecular Formula | C5H10N3O4P |
Hydrogen Bond Donor Count | 5 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 0 |
Exact Mass | 207.04089281 g/mol |
Monoisotopic Mass | 207.04089281 g/mol |
Topological Polar Surface Area | 143 Ų |
Heavy Atom Count | 13 |
Formal Charge | 0 |
Complexity | 124 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Neuromuscular Agents
Drugs used for their actions on skeletal muscle. Included are agents that act directly on skeletal muscle, those that alter neuromuscular transmission (NEUROMUSCULAR BLOCKING AGENTS), and drugs that act centrally as skeletal muscle relaxants (MUSCLE RELAXANTS, CENTRAL). Drugs used in the treatment of movement disorders are ANTI-DYSKINESIA AGENTS. (See all compounds classified as Neuromuscular Agents.)
Potassium Channel Blockers
A class of drugs that act by inhibition of potassium efflux through cell membranes. Blockade of potassium channels prolongs the duration of ACTION POTENTIALS. They are used as ANTI-ARRHYTHMIA AGENTS and VASODILATOR AGENTS. (See all compounds classified as Potassium Channel Blockers.)
GDUFA
DMF Review : Complete
Rev. Date : 2022-10-06
Pay. Date : 2022-09-15
DMF Number : 37447
Submission : 2022-09-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-08
Pay. Date : 2022-06-14
DMF Number : 34624
Submission : 2020-02-29
Status : Active
Type : II
NDC Package Code : 69988-0053
Start Marketing Date : 2020-08-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 65977-0138
Start Marketing Date : 2018-11-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69766-082
Start Marketing Date : 2020-02-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products...
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
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Details:
Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium channel blocker that received approval to treat Lambert-Eaton myasthenic syndrome in Japan.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Brand Name: Firdapse
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Catalyst Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 24, 2024
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Catalyst Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Catalyst Pharma Sub-Licensee Gets Approval For FIRDAPSE® in Japan
Details : Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium channel blocker that received approval to treat Lambert-Eaton myasthenic syndrome in Japan.
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 24, 2024
Details:
Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium channel blocker that recieved FDA approval for its max dose to treat Lambert-Eaton myasthenic syndrome.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Brand Name: Firdapse
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 30, 2024
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Catalyst Receives U.S. FDA Approval For Increased Maximum Daily Dose For FIRDAPSE®
Details : Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium channel blocker that recieved FDA approval for its max dose to treat Lambert-Eaton myasthenic syndrome.
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 30, 2024
Details:
Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Brand Name: Firdapse
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: DyDo Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 2023
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : DyDo Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Catalyst Pharmaceuticals Announces FIRDAPSE® New Drug Application Submitted in Japan by Partner D...
Details : Firdapse (amifampridine) is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that causes depolarization of the presynaptic membrane and slows or inhibits repolarization.
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 18, 2023
Details:
Firdapse (amifampridine) is approved for the treatment of Lambert-Eaton myasthenic syndrome and FDA recently accepted to review the Company's sNDA to increase the indicated maximum daily dosage of amifampridine tablets 10 mg from 80mg to 100mg.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Brand Name: Firdapse
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 13, 2023
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Firdapse (amifampridine) is approved for the treatment of Lambert-Eaton myasthenic syndrome and FDA recently accepted to review the Company's sNDA to increase the indicated maximum daily dosage of amifampridine tablets 10 mg from 80mg to 100mg.
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 13, 2023
Details:
Firdapse (amifampridine phosphate) is a broad spectrum potassium channel blocker. Amifampridine is the only evidence-based, FDA-approved treatment for adult patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Brand Name: Firdapse
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 23, 2023
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Firdapse (amifampridine phosphate) is a broad spectrum potassium channel blocker. Amifampridine is the only evidence-based, FDA-approved treatment for adult patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 23, 2023
Details:
A favorable decision from the Federal Court of Canada setting aside second time decision of Canada’s national healthcare regulatory agency, Health Canada, to approve Ruzurgi® (amifampridine) for Lambert-Eaton Myasthenic Syndrome ("LEMS") patients.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Brand Name: Ruzurgi
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: KYE Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2022
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : KYE Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : A favorable decision from the Federal Court of Canada setting aside second time decision of Canada’s national healthcare regulatory agency, Health Canada, to approve Ruzurgi® (amifampridine) for Lambert-Eaton Myasthenic Syndrome ("LEMS") patients.
Brand Name : Ruzurgi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 11, 2022
Details:
FIRDAPSE® (amifampridine phosphate) Tablets 10 mg is an oral, nonspecific, voltage-dependent, potassium channel blocker that causes depolarization of presynaptic membrane and slows or inhibits repolarization for treatment of adults with Lambert-Eaton myasthenic syndrome.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Brand Name: Firdapse
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2022
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Not Applicable
Deal Type : Not Applicable
Catalyst Pharmaceuticals Further Strengthens FIRDAPSE® U.S. Patent Portfolio
Details : FIRDAPSE® (amifampridine phosphate) Tablets 10 mg is an oral, nonspecific, voltage-dependent, potassium channel blocker that causes depolarization of presynaptic membrane and slows or inhibits repolarization for treatment of adults with Lambert-Eaton my...
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 02, 2022
Details:
U.S. FDA approval of Ruzurgi® (Jacobus Pharmaceutical Company's amifampridine product) for the treatment of pediatric patients with Lambert-Eaton myasthenic syndrome ("LEMS") violated Catalyst's exclusivity for FIRDAPSE® (amifampridine) Tablets 10 mg under the Orphan Drug Act.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Brand Name: Ruzurgi
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2022
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Catalyst Pharmaceuticals Reports that the FDA Marketing Approval Previously Granted for Ruzurgi® ...
Details : U.S. FDA approval of Ruzurgi® (Jacobus Pharmaceutical Company's amifampridine product) for the treatment of pediatric patients with Lambert-Eaton myasthenic syndrome ("LEMS") violated Catalyst's exclusivity for FIRDAPSE® (amifampridine) Tablets 10 mg u...
Brand Name : Ruzurgi
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 03, 2022
Details:
Firdapse® (amifampridine) Tablets 10 mg for the treatment of adults with LEMS was approved in 2018 by the U.S. Food & Drug Administration ("FDA"), and Firdapse® is commercially available in the United States as a treatment for adults with LEMS.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Brand Name: Firdapse
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2021
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Firdapse® (amifampridine) Tablets 10 mg for the treatment of adults with LEMS was approved in 2018 by the U.S. Food & Drug Administration ("FDA"), and Firdapse® is commercially available in the United States as a treatment for adults with LEMS.
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 30, 2021
Details:
DyDo Pharma will have joint rights to develop Firdapse® (amifampridine phosphate), and exclusive rights to commercialize the product, in Japan. Firdapse® is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that slows or inhibits repolarization.
Lead Product(s): Amifampridine Phosphate
Therapeutic Area: Immunology Brand Name: Firdapse
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: DyDo Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement June 28, 2021
Lead Product(s) : Amifampridine Phosphate
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : DyDo Pharma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : DyDo Pharma will have joint rights to develop Firdapse® (amifampridine phosphate), and exclusive rights to commercialize the product, in Japan. Firdapse® is an oral, nonspecific, voltage-dependent, potassium (K+) channel blocker that slows or inhibits ...
Brand Name : Firdapse
Molecule Type : Small molecule
Upfront Cash : Undisclosed
June 28, 2021
Regulatory Info :
Registration Country : Sweden
Brand Name : Firdapse
Dosage Form : TABLET
Dosage Strength : 10 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
A Amifampridine Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amifampridine Phosphate, including repackagers and relabelers. The FDA regulates Amifampridine Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amifampridine Phosphate 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 Amifampridine Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amifampridine Phosphate supplier is an individual or a company that provides Amifampridine Phosphate active pharmaceutical ingredient (API) or Amifampridine Phosphate finished formulations upon request. The Amifampridine Phosphate suppliers may include Amifampridine Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Amifampridine Phosphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amifampridine Phosphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Amifampridine Phosphate active pharmaceutical ingredient (API) in detail. Different forms of Amifampridine Phosphate DMFs exist exist since differing nations have different regulations, such as Amifampridine Phosphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amifampridine Phosphate DMF submitted to regulatory agencies in the US is known as a USDMF. Amifampridine Phosphate USDMF includes data on Amifampridine Phosphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amifampridine Phosphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amifampridine Phosphate 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 Amifampridine Phosphate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amifampridine Phosphate 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 Amifampridine Phosphate 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 Amifampridine Phosphate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amifampridine Phosphate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Amifampridine Phosphate suppliers with NDC on PharmaCompass.
Amifampridine Phosphate 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 Amifampridine Phosphate 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 Amifampridine Phosphate GMP manufacturer or Amifampridine Phosphate GMP API supplier for your needs.
A Amifampridine Phosphate CoA (Certificate of Analysis) is a formal document that attests to Amifampridine Phosphate's compliance with Amifampridine Phosphate specifications and serves as a tool for batch-level quality control.
Amifampridine Phosphate CoA mostly includes findings from lab analyses of a specific batch. For each Amifampridine Phosphate 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.
Amifampridine Phosphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Amifampridine Phosphate EP), Amifampridine Phosphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amifampridine Phosphate USP).
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