Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. Anhydrous Ceftriaxone Sodium
2. Benaxona
3. Cefatriaxone
4. Cefaxona
5. Ceftrex
6. Ceftriaxon
7. Ceftriaxon Curamed
8. Ceftriaxon Hexal
9. Ceftriaxona Andreu
10. Ceftriaxona Ldp Torlan
11. Ceftriaxone
12. Ceftriaxone Irex
13. Ceftriaxone Sodium
14. Ceftriaxone Sodium, Anhydrous
15. Ceftriaxone, Disodium Salt
16. Ceftriaxone, Disodium Salt, Hemiheptahydrate
17. Lendacin
18. Longacef
19. Longaceph
20. Ro 13 9904
21. Ro 13-9904
22. Ro 139904
23. Ro-13-9904
24. Ro13 9904
25. Ro13-9904
26. Ro139904
27. Rocefalin
28. Rocefin
29. Rocephin
30. Rocephine
31. Tacex
32. Terbac
1. Ceftriaxone Sodium
2. Ceftriaxone
3. 74578-69-1
4. 104376-79-6
5. Ro-139904
6. Ceftriaxone Sodium Salt
7. Octx
8. Ceftriaxone Sodium Trihydrate
9. Schembl537013
10. Chembl1200995
11. Mfcd00941454
12. Akos015961150
13. Ac-1851
14. Disodium;(6r,7r)-7-[[(2e)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(2-methyl-6-oxido-5-oxo-1,2,4-triazin-3-yl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
15. Sodium (6r,7r)-7-((e)-2-(2-aminothiazol-4-yl)-2-(methoxyimino)acetamido)-3-((6-hydroxy-2-methyl-5-oxo-2,5-dihydro-1,2,4-triazin-3-ylthio)methyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
16. Sodium;(6r,7r)-7-[[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(2-methyl-5,6-dioxo-1h-1,2,4-triazin-3-yl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
| Molecular Weight | 576.6 g/mol |
|---|---|
| Molecular Formula | C18H17N8NaO7S3 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 13 |
| Rotatable Bond Count | 8 |
| Exact Mass | 576.02800271 g/mol |
| Monoisotopic Mass | 576.02800271 g/mol |
| Topological Polar Surface Area | 291 Ų |
| Heavy Atom Count | 37 |
| Formal Charge | 0 |
| Complexity | 1120 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Rocephin |
| PubMed Health | Ceftriaxone (Injection) |
| Drug Classes | Antibiotic |
| Drug Label | Rocephin is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-t... |
| Active Ingredient | Ceftriaxone sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Hoffmann La Roche |
| 2 of 2 | |
|---|---|
| Drug Name | Rocephin |
| PubMed Health | Ceftriaxone (Injection) |
| Drug Classes | Antibiotic |
| Drug Label | Rocephin is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. Ceftriaxone sodium is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-t... |
| Active Ingredient | Ceftriaxone sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Hoffmann La Roche |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
J - Antiinfectives for systemic use
J01 - Antibacterials for systemic use
J01D - Other beta-lactam antibacterials
J01DD - Third-generation cephalosporins
J01DD04 - Ceftriaxone
API SUPPLIERS
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29982
Submission : 2016-11-28
Status : Active
Type : II
Date of Issue : 2020-04-16
Valid Till : 2022-07-06
Written Confirmation Number : WC-0378A2
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32857
Submission : 2018-06-12
Status : Active
Type : II
Registrant Name : UK Chemical Farm Co., Ltd.
Registration Date : 2024-01-24
Registration Number : 20170413-116-G-139-13(7)
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd.
Manufacturer Address : Economy & Technological Development Zone, First Medical Zone, Datong, Shanxi, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33501
Submission : 2019-02-28
Status : Active
Type : II
Registrant Name : UK Chemical Farm Co., Ltd.
Registration Date : 2024-01-24
Registration Number : 20170413-116-G-139-13(7)
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd.
Manufacturer Address : Economy & Technological Development Zone, First Medical Zone, Datong, Shanxi, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24160
Submission : 2010-08-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20077
Submission : 2006-11-09
Status : Inactive
Type : II
Certificate Number : R1-CEP 2006-305 - Rev 03
Issue Date : 2022-07-15
Type : Chemical
Substance Number : 991
Status : Valid
Registration Number : 220MF10091
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2008-03-28
Latest Date of Registration : --
NDC Package Code : 51065-004
Start Marketing Date : 2012-07-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2018-01-23
Registration Number : 20180123-116-G-147-14
Manufacturer Name : (주)경보약약@[Raw product manufacturer]Sinopharm Weiqida Pharmaceutical Co. Ltd.@Henan Kangda Pharmaceutical Co., Ltd.
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do @ [Production Factory] Economic & Technological Development Zone First Medical Zone, Datong, Shanxi, China. @ No.66 , Jingwu Road, Xiangcheng City, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17884
Submission : 2004-12-04
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-158 - Rev 05
Issue Date : 2019-07-02
Type : Chemical
Substance Number : 991
Status : Valid
Registration Number : 219MF10097
Registrant's Address : 57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Initial Date of Registration : 2007-03-14
Latest Date of Registration : --
Registrant Name : Hanmi Precision Chemical Co., Ltd.
Registration Date : 2009-09-24
Registration Number : 20090924-127-G-28-02
Manufacturer Name : Hanmi Precision Chemical Co., Ltd.
Manufacturer Address : 57 Gyeongje-ro, Siheung-si, Gyeonggi-do
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13656
Submission : 1998-09-01
Status : Inactive
Type : II
Certificate Number : R1-CEP 2001-084 - Rev 01
Issue Date : 2008-05-06
Type : Chemical
Substance Number : 991
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19337
Submission : 2006-04-04
Status : Inactive
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
Details:
Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.
Lead Product(s): Zoliflodacin,Ceftriaxone,Azithromycin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: The Global Antibiotic Research and Development Partnership
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 17, 2020
Lead Product(s) : Zoliflodacin,Ceftriaxone,Azithromycin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : The Global Antibiotic Research and Development Partnership
Deal Size : Undisclosed
Deal Type : Agreement
GARDP, Dr. Reddy’s and Aurigene Pharmaceutical Services Limited Sign MOU for Antibiotic Access T...
Details : Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
December 17, 2020
Details:
Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.
Lead Product(s): Zoliflodacin,Ceftriaxone,Azithromycin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: The Global Antibiotic Research and Development Partnership
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 17, 2020
Lead Product(s) : Zoliflodacin,Ceftriaxone,Azithromycin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : The Global Antibiotic Research and Development Partnership
Deal Size : Undisclosed
Deal Type : Agreement
GARDP, Dr. Reddy’s and Aurigene Pharmaceutical Services Limited Sign MOU for Antibiotic Access T...
Details : Through this MOU, the parties will seek to collaborate on efforts to determine market potential for zoliflodacin, therapeutic value to patients and explore possibilities to enter into future manufacturing and supply agreements.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
December 17, 2020
Details:
Zoliflodacin, an antibiotic, is currently undergoing evaluation in late-stage clinical trials with patients for treating gonorrhea, in combination with ceftriaxone/azithromycin.
Lead Product(s): Zoliflodacin,Ceftriaxone,Azithromycin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 24, 2024
Lead Product(s) : Zoliflodacin,Ceftriaxone,Azithromycin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Innoviva’s Zoliflodacin Phase 3 Data in Uncomplicated Gonorrhea Announced at ESCMID 2024
Details : Zoliflodacin, an antibiotic, is currently undergoing evaluation in late-stage clinical trials with patients for treating gonorrhea, in combination with ceftriaxone/azithromycin.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 24, 2024
Details:
Elores, a cutting-edge antibiotic novel combination of Ceftriaxone (third generation beta-lactam cephalosporin), Sulbactam (beta-lactamase inhibitor) and Disodium EDTA (Class 1 Antibiotic Resistance Breaker) for complicated urinary tract infections.
Lead Product(s): Ceftriaxone,Edetate Calcium Disodium,Sulbactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Elores
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2023
Lead Product(s) : Ceftriaxone,Edetate Calcium Disodium,Sulbactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Venus Remedies Expands Reach with the Launch of Elores in Ecuador
Details : Elores, a cutting-edge antibiotic novel combination of Ceftriaxone (third generation beta-lactam cephalosporin), Sulbactam (beta-lactamase inhibitor) and Disodium EDTA (Class 1 Antibiotic Resistance Breaker) for complicated urinary tract infections.
Brand Name : Elores
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 14, 2023
Details:
Under the agreement, Hasten acquired Roche's China mainland rights for Rocephin® (ceftriaxone sodium), a long-acting, broad spectrum cephalosporin antibiotic, including the product's marketing authorization and certain intellectual property, including trademarks.
Lead Product(s): Ceftriaxone
Therapeutic Area: Infections and Infectious Diseases Brand Name: Rocephin
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Hasten Biopharmaceutic
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition May 04, 2023
Lead Product(s) : Ceftriaxone
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Hasten Biopharmaceutic
Deal Size : Undisclosed
Deal Type : Acquisition
Hasten Acquires Commercial Rights In China For Roche’s Antibiotic Rocephin®
Details : Under the agreement, Hasten acquired Roche's China mainland rights for Rocephin® (ceftriaxone sodium), a long-acting, broad spectrum cephalosporin antibiotic, including the product's marketing authorization and certain intellectual property, including t...
Brand Name : Rocephin
Molecule Type : Small molecule
Upfront Cash : Undisclosed
May 04, 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : CEFTRIAXONE THINKS
Dosage Form : Powder And Solvent For Injection
Dosage Strength : 1 g/3.5 ml
Packaging : 1 UNIT 1000 MG - PARENTERAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Generic
Registration Country : Pakistan
Brand Name : Ceftrixin I/M
Dosage Form : I/M INJECTION
Dosage Strength : 1G
Packaging : 1x1 vial
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Pakistan
Regulatory Info : RX
Registration Country : USA
Brand Name : CEFTRIAXONE
Dosage Form : INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
Dosage Strength : EQ 500MG BASE/VIAL
Packaging :
Approval Date : 2008-01-11
Application Number : 65305
Regulatory Info : RX
Registration Country : USA
Regulatory Info : Generic
Registration Country : South Korea
Brand Name : HANLIM CEFTRIAXONE SODIUM
Dosage Form : INJECTION
Dosage Strength : 500MG
Packaging : 10V
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Korea
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CEFTRIAXONE
Dosage Form : INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
Dosage Strength : EQ 1GM BASE/VIAL
Packaging :
Approval Date : 2003-09-30
Application Number : 65125
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name :
Dosage Form : Powder for Injection
Dosage Strength : 2G
Packaging : 1 vial powder
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Turkey
Brand Name : Cefridem
Dosage Form : Powder for I.V. Injection
Dosage Strength : 1G
Packaging : 1 vial + 1 ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Regulatory Info :
Registration Country : Norway
Brand Name : Ceftriaxon Stragen
Dosage Form : Powder for injection fluid, resolution
Dosage Strength : 500 mg
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CEFTRIAXONE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10GM BASE/VIAL
Packaging :
Approval Date : 2013-01-07
Application Number : 91068
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : CEFTRIAXONE ZENTIVA
Dosage Form : Powder And Solvent For Solution
Dosage Strength : 1 g
Packaging : 1 UNIT 1000 MG - PARENTERAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Towa Pharma is dedicated to researching, developing, producing, and promoting generic drugs.
Regulatory Info :
Registration Country : Italy
Brand Name : CEFTRIAXONE THINKS
Dosage Form : Powder And Solvent For Injection
Dosage Strength : 1 g/3.5 ml
Packaging : 1 UNIT 1000 MG - PARENTERAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Rocefin
Dosage Form : Ceftriaxone 1.000Mg 1 Unit Parenteral Use
Dosage Strength : 1 vial IM 1 g + 1 ampoule solv 3.5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Eraxitron
Dosage Form : Ceftriaxone 1.000Mg 1 Unit Parenteral Use
Dosage Strength : 1 vial IM 1 g + 1 ampoule solv 3.5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Generic
Registration Country : Italy
Brand Name : Axobat
Dosage Form : Injectable
Dosage Strength : 500MG
Packaging : 2 ML
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Ceftriaxone
Dosage Form : Ceftriaxone 1.000Mg 1 Unit Parenteral Use
Dosage Strength : 1 vial IM 1 g + 1 ampoule solv 3.5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Ceftriaxone
Dosage Form : Ceftriaxone 2.000Mg 10 Units Parenteral Use Ev
Dosage Strength : 10 vials 2 g groun for infusion
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Generic
Registration Country : Turkey
Brand Name :
Dosage Form : POWDER FOR INJECTION
Dosage Strength : 2G
Packaging : 1 Vial + 1 Lidocaine Amp Or 1 Or 10 Vials Without Solvent
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
Regulatory Info :
Registration Country : Italy
Brand Name : CEFTRIAXONE ZENTIVA
Dosage Form : Powder And Solvent For Solution
Dosage Strength : 1 g
Packaging : 1 UNIT 1000 MG - PARENTERAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
ceftriaxonnatrium (hemiheptahydrat)
Brand Name : Ceftriaxone Want Fullerton
Dosage Form : POWDER FOR SOLUTION FOR INJECTION
Dosage Strength : 1 G
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 : Norway
Brand Name : Ceftriaxon Villerton
Dosage Form : Powder for injection fluid, resolution
Dosage Strength : 1 g
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Ceftriaxone-AFT
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Ceftriaxone-AFT
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Ceftriaxone Viatris
Dosage Form :
Dosage Strength :
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Ceftriaxone Viatris
Dosage Form :
Dosage Strength :
Packaging : 10
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Ceftriaxone Viatris
Dosage Form :
Dosage Strength :
Packaging : 10
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Actylis
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : Hydrochloric Acid NF
Application : Parenteral
Excipient Details : A&C's Hydrochloric Acid NF is used as a low pH neutralizing agent for pharmaceutical applications.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
Dosage Form : Tablet
Grade : Not Available
Brand Name : DEXTROSE MONOHYDRATE F
Application : Fillers, Diluents & Binders
Excipient Details : Dextrose monohydrate provides key excipient and nutrient benefits as a filler/binder and a carbohydrate source. Glucose or dextrose is the monomer of natural starch polymer.
Dosage Form : Injectable / Parenteral
Grade : Not Available
Brand Name : LYCADEX® BIOPHARMA
Application : Parenteral
Excipient Details : It is used upstream in the cell culture process as an energy and carbon source during the production of therapeutic proteins
Pharmacopoeia Ref : EP/USP
Technical Specs : Not Available
Ingredient(s) : Dextrose Monohydrate, low endotoxin
Dosage Form : Injectable / Parenteral
Grade : Not Available
Application : Parenteral
Excipient Details : It is a dextrose monohydrate pyrogen-free that is a physiological sugar used to provide excipient and API benefits.
Dosage Form : Tablet
Grade : Not Available
Brand Name : ROQUETTE DEXTROSE MONOHYD...
Application : Fillers, Diluents & Binders
Excipient Details : Dextrose monohydrate provides key excipient and nutrient benefits as a filler/binder and a carbohydrate source. Glucose or dextrose is the monomer of natural starch polymer.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Parenteral
Fillers, Diluents & Binders
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
A Ceftriaxone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ceftriaxone, including repackagers and relabelers. The FDA regulates Ceftriaxone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ceftriaxone 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 Ceftriaxone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ceftriaxone supplier is an individual or a company that provides Ceftriaxone active pharmaceutical ingredient (API) or Ceftriaxone finished formulations upon request. The Ceftriaxone suppliers may include Ceftriaxone API manufacturers, exporters, distributors and traders.
click here to find a list of Ceftriaxone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ceftriaxone DMF (Drug Master File) is a document detailing the whole manufacturing process of Ceftriaxone active pharmaceutical ingredient (API) in detail. Different forms of Ceftriaxone DMFs exist exist since differing nations have different regulations, such as Ceftriaxone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ceftriaxone DMF submitted to regulatory agencies in the US is known as a USDMF. Ceftriaxone USDMF includes data on Ceftriaxone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ceftriaxone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ceftriaxone 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 Ceftriaxone Drug Master File in Japan (Ceftriaxone JDMF) empowers Ceftriaxone 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 Ceftriaxone JDMF during the approval evaluation for pharmaceutical products. At the time of Ceftriaxone 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 Ceftriaxone 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 Ceftriaxone Drug Master File in Korea (Ceftriaxone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ceftriaxone. The MFDS reviews the Ceftriaxone KDMF as part of the drug registration process and uses the information provided in the Ceftriaxone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ceftriaxone 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 Ceftriaxone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ceftriaxone suppliers with KDMF on PharmaCompass.
A Ceftriaxone CEP of the European Pharmacopoeia monograph is often referred to as a Ceftriaxone Certificate of Suitability (COS). The purpose of a Ceftriaxone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ceftriaxone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ceftriaxone to their clients by showing that a Ceftriaxone CEP has been issued for it. The manufacturer submits a Ceftriaxone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ceftriaxone CEP holder for the record. Additionally, the data presented in the Ceftriaxone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ceftriaxone DMF.
A Ceftriaxone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ceftriaxone 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 Ceftriaxone suppliers with CEP (COS) on PharmaCompass.
A Ceftriaxone written confirmation (Ceftriaxone WC) is an official document issued by a regulatory agency to a Ceftriaxone manufacturer, verifying that the manufacturing facility of a Ceftriaxone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ceftriaxone APIs or Ceftriaxone finished pharmaceutical products to another nation, regulatory agencies frequently require a Ceftriaxone WC (written confirmation) as part of the regulatory process.
click here to find a list of Ceftriaxone suppliers with Written Confirmation (WC) 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 Ceftriaxone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ceftriaxone 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 Ceftriaxone 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 Ceftriaxone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ceftriaxone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ceftriaxone suppliers with NDC on PharmaCompass.
Ceftriaxone 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 Ceftriaxone 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 Ceftriaxone GMP manufacturer or Ceftriaxone GMP API supplier for your needs.
A Ceftriaxone CoA (Certificate of Analysis) is a formal document that attests to Ceftriaxone's compliance with Ceftriaxone specifications and serves as a tool for batch-level quality control.
Ceftriaxone CoA mostly includes findings from lab analyses of a specific batch. For each Ceftriaxone 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.
Ceftriaxone may be tested according to a variety of international standards, such as European Pharmacopoeia (Ceftriaxone EP), Ceftriaxone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ceftriaxone USP).
LOOKING FOR A SUPPLIER?
