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1. Alpha Heparin
2. Alpha-heparin
3. Heparin
4. Heparin Sodium
5. Heparin, Sodium
6. Heparin, Unfractionated
7. Heparinic Acid
8. Liquaemin
9. Unfractionated Heparin
1. (2s,3s,4r,5r,6r)-6-{[(2s,3s,4s,5r,6s)-6-{[(2r,3s,4s,5r)-2-carboxy-4,6-dihydroxy-5-(sulfooxy)oxan-3-yl]oxy}-2-hydroxy-4-(sulfomethyl)-5-(sulfooxy)oxan-3-yl]oxy}-3-{[(2r,3r,4r,5s,6r)-3-acetamido-4,5-dihydroxy-6-[(sulfooxy)methyl]oxan-2-yl]oxy}-4,5-dihydroxyoxane-2-carboxylic Acid
2. Hepflush
3. Chembl526514
4. Gtpl4214
5. S01xa14
6. Bdbm50480251
7. (2s,3s,4r,5r,6r)-3-[(2r,3r,4r,5s,6r)-3-acetamido-4,5-dihydroxy-6-(sulfooxymethyl)oxan-2-yl]oxy-6-[(2s,3s,4s,5r,6s)-6-[(2r,3s,4s,5r)-2-carboxy-4,6-dihydroxy-5-sulfooxyoxan-3-yl]oxy-2-hydroxy-4-(sulfomethyl)-5-sulfooxyoxan-3-yl]oxy-4,5-dihydroxyoxane-2-carboxylic Acid
1. 9005-49-6
Molecular Weight | 1039.9 g/mol |
---|---|
Molecular Formula | C26H41NO34S4 |
XLogP3 | -10.4 |
Hydrogen Bond Donor Count | 14 |
Hydrogen Bond Acceptor Count | 34 |
Rotatable Bond Count | 18 |
Exact Mass | 1039.0392821 g/mol |
Monoisotopic Mass | 1039.0392821 g/mol |
Topological Polar Surface Area | 589 Ų |
Heavy Atom Count | 65 |
Formal Charge | 0 |
Complexity | 2140 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 19 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Heparin sodium |
Drug Label | Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. They contain no bacteriostat or antimicrobial agent or added buffer. Edetate disodium, anhydrous is ad... |
Active Ingredient | Heparin sodium |
Dosage Form | Injectable |
Route | Injection |
Strength | 5,000 units/ml; 10,000 units/ml; 20,000 units/ml; 1,000 units/ml |
Market Status | Prescription |
Company | Hospira; Shenzhen Techdow; Sandoz; Pfizer; Fresenius Kabi Usa; Hikma Maple; Sagent Pharms |
2 of 2 | |
---|---|
Drug Name | Heparin sodium |
Drug Label | Intravenous solutions with heparin sodium (derived from porcine intestinal mucosa) are sterile, nonpyrogenic fluids for intravenous administration. They contain no bacteriostat or antimicrobial agent or added buffer. Edetate disodium, anhydrous is ad... |
Active Ingredient | Heparin sodium |
Dosage Form | Injectable |
Route | Injection |
Strength | 5,000 units/ml; 10,000 units/ml; 20,000 units/ml; 1,000 units/ml |
Market Status | Prescription |
Company | Hospira; Shenzhen Techdow; Sandoz; Pfizer; Fresenius Kabi Usa; Hikma Maple; Sagent Pharms |
Anticoagulants
Agents that prevent BLOOD CLOTTING. (See all compounds classified as Anticoagulants.)
Fibrinolytic Agents
Fibrinolysin or agents that convert plasminogen to FIBRINOLYSIN. (See all compounds classified as Fibrinolytic Agents.)
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Undisclosed
Lead Product(s): Insulin Glulisine,Insulin aspart,Neutral Protamine Hagedorn Insulin,Glucagon,Glucose,Heparin Sodium
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Protein
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 22, 2016
Lead Product(s) : Insulin Glulisine,Insulin aspart,Neutral Protamine Hagedorn Insulin,Glucagon,Glucose,Heparin Sodium
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
September 22, 2016
Details:
Undisclosed
Lead Product(s): Taurolidine,Heparin Sodium
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 12, 2025
Lead Product(s) : Taurolidine,Heparin Sodium
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections...
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
February 12, 2025
Details:
Undisclosed
Lead Product(s): Taurolidine,Heparin Sodium
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 04, 2024
Lead Product(s) : Taurolidine,Heparin Sodium
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
December 04, 2024
Details:
Undisclosed
Lead Product(s): Taurolidine,Heparin Sodium
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 27, 2024
Lead Product(s) : Taurolidine,Heparin Sodium
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
November 27, 2024
Details:
Through the agreement, Cordemix will supply DefenCath (taurolidine and heparin) to dialysis clinics for CRBSI in adult patients with kidney failure receiving chronic hemodialysis.
Lead Product(s): Taurolidine,Heparin Sodium
Therapeutic Area: Immunology Brand Name: Defencath
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 19, 2024
Lead Product(s) : Taurolidine,Heparin Sodium
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Undisclosed
Deal Type : Agreement
CorMedix Inc. Announces New Commercial Agreement
Details : Through the agreement, Cordemix will supply DefenCath (taurolidine and heparin) to dialysis clinics for CRBSI in adult patients with kidney failure receiving chronic hemodialysis.
Product Name : Defencath
Product Type : Antibiotic
Upfront Cash : Undisclosed
September 19, 2024
Details:
Through the agreement, the company will focus on the supply and commercialization of DefenCath (taurolidine and heparin) for the treatment of catheter-related bloodstream infections.
Lead Product(s): Taurolidine,Heparin Sodium
Therapeutic Area: Immunology Brand Name: Defencath
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: ARC Dialysis, LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 04, 2024
Lead Product(s) : Taurolidine,Heparin Sodium
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : ARC Dialysis, LLC
Deal Size : Undisclosed
Deal Type : Agreement
CorMedix Inc. Announces Commercial Agreement With ARC Dialysis, LLC
Details : Through the agreement, the company will focus on the supply and commercialization of DefenCath (taurolidine and heparin) for the treatment of catheter-related bloodstream infections.
Product Name : Defencath
Product Type : Antibiotic
Upfront Cash : Undisclosed
August 04, 2024
Details:
Undisclosed
Lead Product(s): VMX-C001,Rivaroxaban,Heparin Sodium
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Enzyme
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 24, 2024
Lead Product(s) : VMX-C001,Rivaroxaban,Heparin Sodium
Therapeutic Area : Hematology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Effects of VMX-C001 on the Anticoagulant Effect of Different Forms of Heparin
Details : Undisclosed
Product Name : Undisclosed
Product Type : Enzyme
Upfront Cash : Inapplicable
July 24, 2024
Details:
The agreement aims for the supply of DefenCath, a combination of taurolidine, a thiadiazinane antimicrobial and heparin, an anti-coagulant, indicated to reduce catheter-related bloodstream infections.
Lead Product(s): Taurolidine,Heparin Sodium
Therapeutic Area: Infections and Infectious Diseases Brand Name: DefenCath
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: CorMedix
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 28, 2024
Lead Product(s) : Taurolidine,Heparin Sodium
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : CorMedix
Deal Size : Undisclosed
Deal Type : Agreement
CorMedix Inc. Announces Commercial Agreement With Top Tier Dialysis Provider
Details : The agreement aims for the supply of DefenCath, a combination of taurolidine, a thiadiazinane antimicrobial and heparin, an anti-coagulant, indicated to reduce catheter-related bloodstream infections.
Product Name : DefenCath
Product Type : Antibiotic
Upfront Cash : Undisclosed
May 28, 2024
Details:
Undisclosed
Lead Product(s): Bivalirudin,Heparin Sodium
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Peptide
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 25, 2023
Lead Product(s) : Bivalirudin,Heparin Sodium
Therapeutic Area : Undisclosed
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
Details : Undisclosed
Product Name : Undisclosed
Product Type : Peptide
Upfront Cash : Inapplicable
July 25, 2023
Details:
CorMedix intends to use the net proceeds for the commercialization of Taurolock Hep500 (taurolidine), approved to be instilled into catheter-based devices for hemodialysis in order to maintain patency of the vascular access device.
Lead Product(s): Taurolidine,Heparin Sodium
Therapeutic Area: Nephrology Brand Name: Defencath
Study Phase: Phase IVProduct Type: Antibiotic
Sponsor: RBC Capital Markets
Deal Size: $40.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering June 28, 2023
Lead Product(s) : Taurolidine,Heparin Sodium
Therapeutic Area : Nephrology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : RBC Capital Markets
Deal Size : $40.0 million
Deal Type : Public Offering
Details : CorMedix intends to use the net proceeds for the commercialization of Taurolock Hep500 (taurolidine), approved to be instilled into catheter-based devices for hemodialysis in order to maintain patency of the vascular access device.
Product Name : Defencath
Product Type : Antibiotic
Upfront Cash : Undisclosed
June 28, 2023
Regulatory Info :
Registration Country : Norway
Brand Name : Hepa Flex
Dosage Form : Infusion fluid, resolution
Dosage Strength : 2.5 IE/ml
Packaging : Plastic bag
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Brand Name : Epsoclar
Dosage Form : Heparin Sodium 5.000Iu 10 Units Parenteral Use
Dosage Strength : 10 VIALS SC EV 5,000 IU 1 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Diclofenac epolaminum; Heparin natricum
Brand Name : Flectoparin Tissugel
Dosage Form : Pfl
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Heparin LEO
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 5000 IU / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Heparine Leo
Dosage Form : Injection fluid, resolution
Dosage Strength : 5 000 IE/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Brand Name : Pharepa
Dosage Form : Heparin Sodium 25,000Iu 1 Unit Parenteral Use
Dosage Strength : 1 vial EV 25,000 IU 5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Brand Name : Heparin LEO
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 5000 IU / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
Brand Name : Ecasolv Preriemp
Dosage Form : Calcium Heparin 12.500Iu 10 Units Parenteral Use
Dosage Strength : 10 syringes preriemp 12,500 IU 0.5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
Brand Name : Disebrin
Dosage Form :
Dosage Strength : Coll 3 Ml 5%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Switzerland
Acidum flufenamicum; Hydroxyethyl salicylas; Heparinum natricum
Brand Name : Assan
Dosage Form : Emgel
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Ukraine
Brand Name : HEPARIN-BIOLIK
Dosage Form : Injection solution
Dosage Strength : 5000IU/1ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Ukraine
Packaging :
Regulatory Info :
Dosage : Injection solution
Dosage Strength : 5000IU/1ML
Brand Name : HEPARIN-BIOLIK
Approval Date :
Application Number :
Registration Country : Ukraine
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Vial
Dosage Strength : 5000IU/ML
Packaging : 10 ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging : 10 ml
Regulatory Info :
Dosage : Vial
Dosage Strength : 5000IU/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Vial
Dosage Strength : 5000IU/ML
Packaging : 1 ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging : 1 ml
Regulatory Info :
Dosage : Vial
Dosage Strength : 5000IU/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Vial
Dosage Strength : 20000IU/ML
Packaging : 1 ml
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging : 1 ml
Regulatory Info :
Dosage : Vial
Dosage Strength : 20000IU/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 5000IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 5000IU
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : South Korea
Brand Name : HANLIM HEPARIN
Dosage Form : INJECTION
Dosage Strength : 25000IU
Packaging : 5ml, 10V
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Korea
Packaging : 5ml, 10V
Regulatory Info : Generic
Dosage : INJECTION
Dosage Strength : 25000IU
Brand Name : HANLIM HEPARIN
Approval Date :
Application Number :
Registration Country : South Korea
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 5000IU/1ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Packaging :
Regulatory Info : Generic
Dosage : Injection
Dosage Strength : 5000IU/1ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : South Korea
Brand Name :
Dosage Form : Injection
Dosage Strength : 25000IU
Packaging : 5ml × 10 Vials
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Korea
Packaging : 5ml × 10 Vials
Regulatory Info : Generic
Dosage : Injection
Dosage Strength : 25000IU
Brand Name :
Approval Date :
Application Number :
Registration Country : South Korea
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 5000IU
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 5000IU
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Turkey
Brand Name : Heparinum
Dosage Form : Solution for IV Inject...
Dosage Strength : 25000IU/5ML
Packaging : 1 vial&10 vials
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Packaging : 1 vial&10 vials
Regulatory Info :
Dosage : Solution for IV Inject...
Dosage Strength : 25000IU/5ML
Brand Name : Heparinum
Approval Date :
Application Number :
Registration Country : Turkey
DRUG PRODUCT COMPOSITIONS
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
29
PharmaCompass offers a list of Heparin Sodium 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 Heparin Sodium manufacturer or Heparin Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Heparin Sodium manufacturer or Heparin Sodium supplier.
PharmaCompass also assists you with knowing the Heparin Sodium API Price utilized in the formulation of products. Heparin Sodium API Price is not always fixed or binding as the Heparin Sodium Price is obtained through a variety of data sources. The Heparin Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Heparin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Heparin Sodium, including repackagers and relabelers. The FDA regulates Heparin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Heparin Sodium 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 Heparin Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Heparin Sodium supplier is an individual or a company that provides Heparin Sodium active pharmaceutical ingredient (API) or Heparin Sodium finished formulations upon request. The Heparin Sodium suppliers may include Heparin Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Heparin Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Heparin Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Heparin Sodium active pharmaceutical ingredient (API) in detail. Different forms of Heparin Sodium DMFs exist exist since differing nations have different regulations, such as Heparin Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Heparin Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Heparin Sodium USDMF includes data on Heparin Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Heparin Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Heparin Sodium 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 Heparin Sodium Drug Master File in Japan (Heparin Sodium JDMF) empowers Heparin Sodium 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 Heparin Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Heparin Sodium 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 Heparin Sodium suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Heparin Sodium Drug Master File in Korea (Heparin Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Heparin Sodium. The MFDS reviews the Heparin Sodium KDMF as part of the drug registration process and uses the information provided in the Heparin Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Heparin Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Heparin Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Heparin Sodium suppliers with KDMF on PharmaCompass.
A Heparin Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Heparin Sodium Certificate of Suitability (COS). The purpose of a Heparin Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Heparin Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Heparin Sodium to their clients by showing that a Heparin Sodium CEP has been issued for it. The manufacturer submits a Heparin Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Heparin Sodium CEP holder for the record. Additionally, the data presented in the Heparin Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Heparin Sodium DMF.
A Heparin Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Heparin Sodium 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 Heparin Sodium suppliers with CEP (COS) 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 Heparin Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Heparin Sodium 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 Heparin Sodium 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 Heparin Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Heparin Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Heparin Sodium suppliers with NDC on PharmaCompass.
Heparin Sodium 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 Heparin Sodium 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 Heparin Sodium GMP manufacturer or Heparin Sodium GMP API supplier for your needs.
A Heparin Sodium CoA (Certificate of Analysis) is a formal document that attests to Heparin Sodium's compliance with Heparin Sodium specifications and serves as a tool for batch-level quality control.
Heparin Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Heparin Sodium 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.
Heparin Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Heparin Sodium EP), Heparin Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Heparin Sodium USP).