Find Amifampridine Phosphate manufacturers, exporters & distributors on PharmaCompass

PharmaCompass

Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

0

CEP/COS

CEP/COS Certifications

0

JDMF

JDMFs Filed

0

EU WC

EU WC

0

KDMF

KDMF

0

VMF

NDC API

API REF. PRICE (USD/KG)

MARKET PLACE

0

API

0

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

0

Canada

Canada

0

Australia

Australia

0

South Africa

South Africa

0

Listed Dossiers

Listed Dossiers

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

PATENTS & EXCLUSIVITIES

0

Health Canada Patents

DIGITAL CONTENT

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

GLOBAL SALES INFORMATION

US Medicaid

NA

Annual Reports

NA

Finished Drug Prices

NA

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

Click the arrow to open the dropdown
read-moreClick the button for full data set
Also known as: Zenas, 3,4-diaminopyridine phosphate, 446254-47-3, Firdapse (tn), Amifampridine phosphate [mi], 3,4-pyridinediamine, phosphate (1:1)
Molecular Formula
C5H10N3O4P
Molecular Weight
207.12  g/mol
InChI Key
KAICRBBQCRKMPO-UHFFFAOYSA-N
FDA UNII
8HF8FIN815

Amifampridine Phosphate
4-Aminopyridine derivative that acts as a POTASSIUM CHANNEL blocker to increase release of ACETYLCHOLINE from nerve terminals. It is used in the treatment of CONGENITAL MYASTHENIC SYNDROMES.
1 2D Structure

Amifampridine Phosphate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
phosphoric acid;pyridine-3,4-diamine
2.1.2 InChI
InChI=1S/C5H7N3.H3O4P/c6-4-1-2-8-3-5(4)7;1-5(2,3)4/h1-3H,7H2,(H2,6,8);(H3,1,2,3,4)
2.1.3 InChI Key
KAICRBBQCRKMPO-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CN=CC(=C1N)N.OP(=O)(O)O
2.2 Other Identifiers
2.2.1 UNII
8HF8FIN815
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 3,4 Diaminopyridine

2. 3,4-diaminopyridine

3. Amifampridine

4. Firdapse

5. Ruzurgi

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 207.12 g/mol
Molecular Formula C5H10N3O4P
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count7
Rotatable Bond Count0
Exact Mass207.04089281 g/mol
Monoisotopic Mass207.04089281 g/mol
Topological Polar Surface Area143 Ų
Heavy Atom Count13
Formal Charge0
Complexity124
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

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.)


4.2 FDA Pharmacological Classification
4.2.1 Pharmacological Classes
Potassium Channel Blocker [EPC]; Potassium Channel Antagonists [MoA]

USDMF

read-more
read-more

01

Hetero Drugs Ltd

India

USDMF

arrow
BIO Partnering at JPM
Not Confirmed

01

BIO Partnering at JPM
Not Confirmed

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

blank

02

BIO Partnering at JPM
Not Confirmed

02

BIO Partnering at JPM
Not Confirmed

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

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

NDC API

read-more
read-more

01

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

AMIFAMPRIDINE PHOSPHATE

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

blank

02

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

AMIFAMPRIDINE PHOSPHATE

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

blank

03

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

AMIFAMPRIDINE PHOSPHATE

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

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

read-more
read-more

01

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Amifampridine Phosphate

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...

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 in the market and in the pipeline, MSN has 6 API (including Oncology) and one finished dosage facilities (one more for Oncology is being built) and an integrated R&D Center for Contract Research And Manufacturing Services (CRAMS) located in Hyderabad. MSN has won the trust of more than 250 customers across 65 countries around the globe covering the US, Europe, Latin America, Middle-East, Asia Pacific, Africa and CIS markets. Our product basket offers 100 APIs
blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

API Reference Price

read-more
read-more
[{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1683225000,"product":"MSN PHARMACEUTICAL PRODUCT NAME AMIFAMPRIDINE PHOSPHATE FQ","address":"MSN HOUSE,PLOT NO.C-24,INDUSTRIAL E SANATH NAGAR,HYDERABAD","city":"HYDERABAD TS","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"NEW YORK JOHN F K","customer":"TO THE ORDER","customerCountry":"UNITED STATES","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"40000","totalValueFC":"19542","currency":"USD","unitRateINR":3216000,"date":"05-May-2023","totalValueINR":"1608000","totalValueInUsd":"19542","indian_port":"HYDERABAD AIR","hs_no":"29199090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE,PLOT NO.C-24,INDUSTRIAL E SANATH NAGAR,HYDERABAD, HYDERABAD TS","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688149800,"product":"AMIFAMPRIDINE PHOSPHATE GMP MENGE 7.2KG - PRODUCT NR. 538.01- AS PER INVOICE","address":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST","city":"GADDAPOTHARAM HYD,TELANGANA","supplier":"CHIRACON GMBH","supplierCountry":"GERMANY","foreign_port":"NA","customer":"TIEFENBACHER API + INGREDIENTS GMBH","customerCountry":"INDIA","quantity":"7.20","actualQuantity":"7.2","unit":"KGS","unitRateFc":"34000","totalValueFC":"269552.6","currency":"EUR","unitRateINR":"3077000.4","date":"01-Jul-2023","totalValueINR":"22154399.69","totalValueInUsd":"269552.6","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SURVEY NO.42, GADDAPOTHARAM,KAZIPA LLY IND AREA, SANGAREDDY DIST"}]
05-May-2023
01-Jul-2023
KGS
overview
Loading...

Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

Upgrade, download data, analyse, strategize, subscribe with us contact

Drugs in Development

read-more
read-more

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

blank

01

Dydo Pharma

Japan
arrow
Biotech Showcase
Not Confirmed

Dydo Pharma

Japan
arrow
Biotech Showcase
Not Confirmed

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

blank

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

blank

02

Biotech Showcase
Not Confirmed
Biotech Showcase
Not Confirmed

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

blank

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

blank

03

Biotech Showcase
Not Confirmed
Biotech Showcase
Not Confirmed

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

blank

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

blank

04

Biotech Showcase
Not Confirmed
Biotech Showcase
Not Confirmed

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

blank

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

blank

05

Biotech Showcase
Not Confirmed
Biotech Showcase
Not Confirmed

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

blank

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

blank

06

Biotech Showcase
Not Confirmed
Biotech Showcase
Not Confirmed

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

blank

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

blank

07

Biotech Showcase
Not Confirmed
Biotech Showcase
Not Confirmed

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

blank

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

blank

08

Biotech Showcase
Not Confirmed
Biotech Showcase
Not Confirmed

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

blank

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

blank

09

Biotech Showcase
Not Confirmed
Biotech Showcase
Not Confirmed

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

blank

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

blank

10

Biotech Showcase
Not Confirmed
Biotech Showcase
Not Confirmed

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

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Digital Content read-more

Create Content with PharmaCompass, ask us

DATA COMPILATION #PharmaFlow

read-more
read-more

NEWS #PharmaBuzz

read-more
read-more

Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

ABOUT THIS PAGE

Amifampridine Phosphate Manufacturers

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.

Amifampridine Phosphate Suppliers

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.

Amifampridine Phosphate USDMF

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.

Amifampridine Phosphate NDC

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).

Finished drug products

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.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Amifampridine Phosphate CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty