Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
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 : 2022-08-12
Valid Till : 2025-07-06
Written Confirmation Number : WC-0378
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 : 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
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 :
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 : 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
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
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
Ceftriaxone Sodium, Sterile And Bacterial Endoto...
Certificate Number : R1-CEP 2003-169 - Rev 01
Status : Valid
Issue Date : 2011-02-18
Type : Chemical
Substance Number : 991
Certificate Number : R1-CEP 2005-189 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2013-10-09
Type : Chemical
Substance Number : 991
Ceftriaxone Sodium, Sterile, Process T
Certificate Number : R0-CEP 2001-087 - Rev 01
Status : Expired
Issue Date : 2004-07-29
Type : Chemical
Substance Number : 991
Certificate Number : R1-CEP 2001-084 - Rev 01
Status : Valid
Issue Date : 2008-05-06
Type : Chemical
Substance Number : 991
Ceftriaxone Sodium, Sterile; Process A
Certificate Number : R1-CEP 1998-013 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2004-11-12
Type : Chemical
Substance Number : 991
Certificate Number : R0-CEP 2001-222 - Rev 02
Status : Expired
Issue Date : 2005-08-22
Type : Chemical
Substance Number : 991
Certificate Number : R1-CEP 2000-017 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2007-05-29
Type : Chemical
Substance Number : 991
Certificate Number : R0-CEP 2003-214 - Rev 00
Status : Expired
Issue Date : 2005-01-26
Type : Chemical
Substance Number : 991
Certificate Number : R1-CEP 1999-192 - Rev 05
Status : Valid
Issue Date : 2018-02-16
Type : Chemical
Substance Number : 991
Certificate Number : R1-CEP 2004-137 - Rev 04
Status : Valid
Issue Date : 2016-09-02
Type : Chemical
Substance Number : 991
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/FDF Prices: Book a Demo to explore the features and consider upgrading later
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Excipients by Applications
Parenteral
Fillers, Diluents & Binders
Digital Content
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
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
91
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 ROCEPHIN KIT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ROCEPHIN KIT, including repackagers and relabelers. The FDA regulates ROCEPHIN KIT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ROCEPHIN KIT 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 ROCEPHIN KIT manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ROCEPHIN KIT supplier is an individual or a company that provides ROCEPHIN KIT active pharmaceutical ingredient (API) or ROCEPHIN KIT finished formulations upon request. The ROCEPHIN KIT suppliers may include ROCEPHIN KIT API manufacturers, exporters, distributors and traders.
click here to find a list of ROCEPHIN KIT suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ROCEPHIN KIT DMF (Drug Master File) is a document detailing the whole manufacturing process of ROCEPHIN KIT active pharmaceutical ingredient (API) in detail. Different forms of ROCEPHIN KIT DMFs exist exist since differing nations have different regulations, such as ROCEPHIN KIT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ROCEPHIN KIT DMF submitted to regulatory agencies in the US is known as a USDMF. ROCEPHIN KIT USDMF includes data on ROCEPHIN KIT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ROCEPHIN KIT USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ROCEPHIN KIT 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 ROCEPHIN KIT Drug Master File in Japan (ROCEPHIN KIT JDMF) empowers ROCEPHIN KIT 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 ROCEPHIN KIT JDMF during the approval evaluation for pharmaceutical products. At the time of ROCEPHIN KIT 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 ROCEPHIN KIT 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 ROCEPHIN KIT Drug Master File in Korea (ROCEPHIN KIT KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ROCEPHIN KIT. The MFDS reviews the ROCEPHIN KIT KDMF as part of the drug registration process and uses the information provided in the ROCEPHIN KIT KDMF to evaluate the safety and efficacy of the drug.
After submitting a ROCEPHIN KIT 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 ROCEPHIN KIT API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ROCEPHIN KIT suppliers with KDMF on PharmaCompass.
A ROCEPHIN KIT CEP of the European Pharmacopoeia monograph is often referred to as a ROCEPHIN KIT Certificate of Suitability (COS). The purpose of a ROCEPHIN KIT CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ROCEPHIN KIT EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ROCEPHIN KIT to their clients by showing that a ROCEPHIN KIT CEP has been issued for it. The manufacturer submits a ROCEPHIN KIT CEP (COS) as part of the market authorization procedure, and it takes on the role of a ROCEPHIN KIT CEP holder for the record. Additionally, the data presented in the ROCEPHIN KIT CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ROCEPHIN KIT DMF.
A ROCEPHIN KIT CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ROCEPHIN KIT 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 ROCEPHIN KIT suppliers with CEP (COS) on PharmaCompass.
A ROCEPHIN KIT written confirmation (ROCEPHIN KIT WC) is an official document issued by a regulatory agency to a ROCEPHIN KIT manufacturer, verifying that the manufacturing facility of a ROCEPHIN KIT active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ROCEPHIN KIT APIs or ROCEPHIN KIT finished pharmaceutical products to another nation, regulatory agencies frequently require a ROCEPHIN KIT WC (written confirmation) as part of the regulatory process.
click here to find a list of ROCEPHIN KIT 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 ROCEPHIN KIT as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ROCEPHIN KIT 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 ROCEPHIN KIT 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 ROCEPHIN KIT and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ROCEPHIN KIT NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ROCEPHIN KIT suppliers with NDC on PharmaCompass.
ROCEPHIN KIT 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 ROCEPHIN KIT 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 ROCEPHIN KIT GMP manufacturer or ROCEPHIN KIT GMP API supplier for your needs.
A ROCEPHIN KIT CoA (Certificate of Analysis) is a formal document that attests to ROCEPHIN KIT's compliance with ROCEPHIN KIT specifications and serves as a tool for batch-level quality control.
ROCEPHIN KIT CoA mostly includes findings from lab analyses of a specific batch. For each ROCEPHIN KIT 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.
ROCEPHIN KIT may be tested according to a variety of international standards, such as European Pharmacopoeia (ROCEPHIN KIT EP), ROCEPHIN KIT JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ROCEPHIN KIT USP).
