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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
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DMF Number : 29982
Submission : 2016-11-28
Status : Active
Type : II
Date of Issue : 2022-08-12
Valid Till : 2025-07-06
Written Confirmation Number : WC-0378
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DMF Number : 32857
Submission : 2018-06-12
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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
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DMF Number : 33501
Submission : 2019-02-28
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Type : II
Registrant Name : Sechang International Co., Ltd.
Registration Date : 2018-07-16
Registration Number : 20170413-116-G-139-13(5)
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd.
Manufacturer Address : Economic & Technological Development Zone, First Medical Zone, Datong, Shanxi, China
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DMF Number : 19337
Submission : 2006-04-04
Status : Inactive
Type : II
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DMF Number : 24160
Submission : 2010-08-31
Status : Inactive
Type : II
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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
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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
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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
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DMF Number : 33015
Submission : 2018-08-01
Status : Inactive
Type : II
Registrant Name : International Pharmaceutical Co., Ltd.
Registration Date : 2019-01-21
Registration Number : 20170413-116-G-139-13(6)
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd.
Manufacturer Address : Economic&Technological Development Zone, First Medical Zone, Datong, Shanxi, China
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About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
About the Company : We are a privately held Italian company founded in 1973. We are a fully integrated manufacturer of Cephalosporin, Carbapenem and Penicillin APIs as well as Finished Dosage Formula...
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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
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Application Number :
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Registration Country : Italy
Regulatory Info : Generic
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Dosage Form : Powder for Injection
Dosage Strength : 2G
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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
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Application Number :
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Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
ceftriaxonnatrium (hemiheptahydrat)
Brand Name : Ceftriaxone MIP
Dosage Form : POWDER FOR SOLUTION FOR INFUSION
Dosage Strength : 2 G
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Application Number :
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Registration Country : Sweden
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
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Registration Country : Italy
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Brand Name : CEFTRIAXONE SUN
Dosage Form : Powder And Solvent For Injection
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Packaging : 1 UNIT 1000 MG - PARENTERAL USE
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Registration Country : Italy
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Brand Name : CEFTRIAXONE MYLAN GENERICS
Dosage Form : Powder And Solvent For Injection
Dosage Strength : 1 g/3.5 ml
Packaging : 1 UNIT 1000 MG - PARENTERAL USE
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Application Number :
Regulatory Info :
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
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Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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Brand Name : Sirtap
Dosage Form : Ceftriaxone 1.000Mg 1 Unit Parenteral Use Ev
Dosage Strength : 1 ampoule EV 1 g + 1 ampoule solv 10 ml
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Registration Country : Italy
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Brand Name : Ceftriaxon Villerton
Dosage Form : Powder for injection fluid, resolution
Dosage Strength : 1 g
Packaging : Hood glass
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Registration Country : Norway
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Brand Name : Ceftriaxone
Dosage Form : Dry Powder Injectable
Dosage Strength : 1GM
Packaging : 10 ml
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Packaging : 10 ml
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Brand Name : Ceftriaxone
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Brand Name : Virexim
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Application Number : 65305
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Brand Name : Ceftriaxone
Dosage Form : Dry Powder Injection
Dosage Strength : 500MG
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Packaging : Vial
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Brand Name : UTRIXONE
Dosage Form : INJECTION
Dosage Strength : 2G
Packaging : Vial
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Dosage Form : Injection
Dosage Strength : 1.5GM
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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.
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
Application : Parenteral
Excipient Details : It is a dextrose monohydrate pyrogen-free that is a physiological sugar used to provide excipient and API benefits.
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PharmaCompass offers a list of Ceftriaxone 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 Ceftriaxone manufacturer or Ceftriaxone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ceftriaxone manufacturer or Ceftriaxone supplier.
PharmaCompass also assists you with knowing the Ceftriaxone API Price utilized in the formulation of products. Ceftriaxone API Price is not always fixed or binding as the Ceftriaxone Price is obtained through a variety of data sources. The Ceftriaxone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 7-Aminoceftriaxone sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 7-Aminoceftriaxone sodium, including repackagers and relabelers. The FDA regulates 7-Aminoceftriaxone sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 7-Aminoceftriaxone 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 7-Aminoceftriaxone sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 7-Aminoceftriaxone sodium supplier is an individual or a company that provides 7-Aminoceftriaxone sodium active pharmaceutical ingredient (API) or 7-Aminoceftriaxone sodium finished formulations upon request. The 7-Aminoceftriaxone sodium suppliers may include 7-Aminoceftriaxone sodium API manufacturers, exporters, distributors and traders.
click here to find a list of 7-Aminoceftriaxone sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 7-Aminoceftriaxone sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of 7-Aminoceftriaxone sodium active pharmaceutical ingredient (API) in detail. Different forms of 7-Aminoceftriaxone sodium DMFs exist exist since differing nations have different regulations, such as 7-Aminoceftriaxone sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 7-Aminoceftriaxone sodium DMF submitted to regulatory agencies in the US is known as a USDMF. 7-Aminoceftriaxone sodium USDMF includes data on 7-Aminoceftriaxone sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 7-Aminoceftriaxone sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 7-Aminoceftriaxone 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 7-Aminoceftriaxone sodium Drug Master File in Japan (7-Aminoceftriaxone sodium JDMF) empowers 7-Aminoceftriaxone 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 7-Aminoceftriaxone sodium JDMF during the approval evaluation for pharmaceutical products. At the time of 7-Aminoceftriaxone 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 7-Aminoceftriaxone 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 7-Aminoceftriaxone sodium Drug Master File in Korea (7-Aminoceftriaxone sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 7-Aminoceftriaxone sodium. The MFDS reviews the 7-Aminoceftriaxone sodium KDMF as part of the drug registration process and uses the information provided in the 7-Aminoceftriaxone sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a 7-Aminoceftriaxone 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 7-Aminoceftriaxone sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 7-Aminoceftriaxone sodium suppliers with KDMF on PharmaCompass.
A 7-Aminoceftriaxone sodium CEP of the European Pharmacopoeia monograph is often referred to as a 7-Aminoceftriaxone sodium Certificate of Suitability (COS). The purpose of a 7-Aminoceftriaxone sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 7-Aminoceftriaxone sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 7-Aminoceftriaxone sodium to their clients by showing that a 7-Aminoceftriaxone sodium CEP has been issued for it. The manufacturer submits a 7-Aminoceftriaxone sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a 7-Aminoceftriaxone sodium CEP holder for the record. Additionally, the data presented in the 7-Aminoceftriaxone sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 7-Aminoceftriaxone sodium DMF.
A 7-Aminoceftriaxone sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 7-Aminoceftriaxone 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 7-Aminoceftriaxone sodium suppliers with CEP (COS) on PharmaCompass.
A 7-Aminoceftriaxone sodium written confirmation (7-Aminoceftriaxone sodium WC) is an official document issued by a regulatory agency to a 7-Aminoceftriaxone sodium manufacturer, verifying that the manufacturing facility of a 7-Aminoceftriaxone sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 7-Aminoceftriaxone sodium APIs or 7-Aminoceftriaxone sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a 7-Aminoceftriaxone sodium WC (written confirmation) as part of the regulatory process.
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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 7-Aminoceftriaxone sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 7-Aminoceftriaxone 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 7-Aminoceftriaxone 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 7-Aminoceftriaxone sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 7-Aminoceftriaxone sodium NDC to their finished compounded human drug products, they may choose to do so.
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7-Aminoceftriaxone 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 7-Aminoceftriaxone 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 7-Aminoceftriaxone sodium GMP manufacturer or 7-Aminoceftriaxone sodium GMP API supplier for your needs.
A 7-Aminoceftriaxone sodium CoA (Certificate of Analysis) is a formal document that attests to 7-Aminoceftriaxone sodium's compliance with 7-Aminoceftriaxone sodium specifications and serves as a tool for batch-level quality control.
7-Aminoceftriaxone sodium CoA mostly includes findings from lab analyses of a specific batch. For each 7-Aminoceftriaxone 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.
7-Aminoceftriaxone sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (7-Aminoceftriaxone sodium EP), 7-Aminoceftriaxone sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (7-Aminoceftriaxone sodium USP).
