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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
API SUPPLIERS
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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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 : 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 : 16650
Submission : 2003-06-16
Status : Active
Type : II
Certificate Number : R1-CEP 2002-203 - Rev 01
Issue Date : 2011-05-23
Type : Chemical
Substance Number : 991
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25946
Submission : 2012-02-29
Status : Inactive
Type : II
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
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Ceftriaxone Sodium (Sterile) (USP/BP/Ph. Eur.)
Date of Issue : 2016-09-06
Valid Till : 2019-07-02
Written Confirmation Number : WC-0145
Address of the Firm : Village- Saidpura,Tehsil-Derabassi, District-Mohali (Punjab) India-140 507
Date of Issue : 2014-03-06
Valid Till : 2017-02-22
Written Confirmation Number : WC-269
Address of the Firm : (UNIT-1), Village-Saidapur, Tehsil-Derabassi, Dist. Mohali(Punjab)-140507
Date of Issue : 2019-08-16
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131N
Address of the Firm : Plot No 121-128,128A-133,138-151 & 159-164 SIDCO Industrial Estate, Alathur, Kan...
Date of Issue : 2019-08-16
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131-A
Address of the Firm : Plot Nos. 121-128, 128A-133, 138-151 & 159-164, SIDCO Industrial Estate, Alathur...
Date of Issue : 2020-04-16
Valid Till : 2022-07-06
Written Confirmation Number : WC-0378A2
Address of the Firm : Plot No 100 Sector 56, HSIIDC, Kundli district sonepat, Haryana
Ceftriaxone Sodium Sterile (BP/USP/EP)
Date of Issue : 2016-07-06
Valid Till : 2019-07-06
Written Confirmation Number : WC-0378
Address of the Firm : Plot No. 100 Sector 56 Phase IV, HSIIDC Kundli, District Sonepat Haryana India
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Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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 : Akums Lifescience Ltd. is a research-based, vertically integrated company specializing in the development, manufacturing and sale of APIs and intermediates. Akums has established i...
About the Company : Asia Pioneer Pharmaceuticals is a leading supplier of fine chemicals, pharmaceutical intermediates, active pharmaceutical ingredients and other compounds. It also offers finished p...
About the Company : We can help your company solve the payment problems during the trading from chinese factories. We supply you with OEM from china.We are professsionals with the competitive price an...
About the Company : We are pharma manufacturing and API trading service which runs round the clock manufacturing services. We strive to deliver the best value to our customers to ever improving servic...
About the Company : Nantong Chem-land Co., Ltd. is located in Nantong city, a developed port city which distance from Shanghai is only 1.5 hours by car. Established in 2006, we have developed quickly ...
About the Company : Nectar Lifesciences Ltd. (NLL) is a knowledge driven organization which constitutes a vital part of fast growing Indian Pharmaceutical Industry. In a short span of existence, NLL h...
About the Company : Established in 1992 as an export-oriented unit (EOU), Orchid Pharma Ltd. (Orchid) is a vertically integrated company spanning the entire pharmaceutical value chain from discovery t...
About the Company : Located in Jinan, Qilu Pharmaceutical is one of the leading pharmaceutical companies in China. It focuses on developing, manufacturing and marketing of generic drugs and active pha...
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Regulatory Info : Generic
Registration Country : Pakistan
Brand Name : Ceftrixin
Dosage Form : I/V INJECTION
Dosage Strength : 1G
Packaging : 1x1 vial
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Pakistan
Regulatory Info : Generic
Registration Country : Pakistan
Brand Name : Noor I/M
Dosage Form : I/M INJECTION
Dosage Strength : 250MG
Packaging : as per requirement
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Pakistan
Regulatory Info :
Registration Country : India
Ceftriaxone; Tazobactam Sodium
Brand Name : Virexim-T
Dosage Form : Injection
Dosage Strength : 1000MG; 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Ceftriaxone; Tazobactam Sodium
Dosage : Injection
Dosage Strength : 1000MG; 250MG
Brand Name : Virexim-T
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name : Stericef
Dosage Form : INJECTION
Dosage Strength : 1G
Packaging :
Approval Date :
Application Number : 65305
Regulatory Info : Generic
Registration Country : India
Packaging :
Regulatory Info : Generic
Dosage : INJECTION
Dosage Strength : 1G
Brand Name : Stericef
Approval Date :
Application Number : 65305
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : Powder for Injection
Dosage Strength : 2G
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Packaging :
Regulatory Info : Generic
Dosage : Powder for Injection
Dosage Strength : 2G
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : INJECTABLE
Dosage Strength : 1000MG
Packaging : Vial
Approval Date :
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Regulatory Info : Generic
Registration Country : India
Packaging : Vial
Regulatory Info : Generic
Dosage : INJECTABLE
Dosage Strength : 1000MG
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Dosage Form : Injection
Dosage Strength : 1G
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Registration Country : China
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Dosage : Injection
Dosage Strength : 1G
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Registration Country : China
Regulatory Info :
Registration Country : Turkey
Brand Name : Taksidem
Dosage Form : Powder for I.V. Inject...
Dosage Strength : 2G
Packaging : 1 vial + 1 ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Packaging : 1 vial + 1 ampoule
Regulatory Info :
Dosage : Powder for I.V. Inject...
Dosage Strength : 2G
Brand Name : Taksidem
Approval Date :
Application Number :
Registration Country : Turkey
Regulatory Info :
Registration Country : Turkey
Brand Name : MOXICUM
Dosage Form : POWDER FOR INJECTION
Dosage Strength : 2000MG
Packaging : ?1 OR ?10 WITH OR WITHOUT SOLVENT (WFI OR LIDOCAINE)
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Packaging : ?1 OR ?10 WITH OR WITHOUT SOLVENT (WFI OR LIDOCAINE)
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Dosage : POWDER FOR INJECTION
Dosage Strength : 2000MG
Brand Name : MOXICUM
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Registration Country : Turkey
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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 Rocephine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rocephine, including repackagers and relabelers. The FDA regulates Rocephine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rocephine 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 Rocephine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rocephine supplier is an individual or a company that provides Rocephine active pharmaceutical ingredient (API) or Rocephine finished formulations upon request. The Rocephine suppliers may include Rocephine API manufacturers, exporters, distributors and traders.
click here to find a list of Rocephine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rocephine DMF (Drug Master File) is a document detailing the whole manufacturing process of Rocephine active pharmaceutical ingredient (API) in detail. Different forms of Rocephine DMFs exist exist since differing nations have different regulations, such as Rocephine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rocephine DMF submitted to regulatory agencies in the US is known as a USDMF. Rocephine USDMF includes data on Rocephine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rocephine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rocephine 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 Rocephine Drug Master File in Japan (Rocephine JDMF) empowers Rocephine 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 Rocephine JDMF during the approval evaluation for pharmaceutical products. At the time of Rocephine 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 Rocephine 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 Rocephine Drug Master File in Korea (Rocephine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rocephine. The MFDS reviews the Rocephine KDMF as part of the drug registration process and uses the information provided in the Rocephine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rocephine 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 Rocephine API can apply through the Korea Drug Master File (KDMF).
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A Rocephine CEP of the European Pharmacopoeia monograph is often referred to as a Rocephine Certificate of Suitability (COS). The purpose of a Rocephine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rocephine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rocephine to their clients by showing that a Rocephine CEP has been issued for it. The manufacturer submits a Rocephine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rocephine CEP holder for the record. Additionally, the data presented in the Rocephine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rocephine DMF.
A Rocephine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rocephine 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 Rocephine suppliers with CEP (COS) on PharmaCompass.
A Rocephine written confirmation (Rocephine WC) is an official document issued by a regulatory agency to a Rocephine manufacturer, verifying that the manufacturing facility of a Rocephine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rocephine APIs or Rocephine finished pharmaceutical products to another nation, regulatory agencies frequently require a Rocephine 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 Rocephine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rocephine 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 Rocephine 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 Rocephine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rocephine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rocephine suppliers with NDC on PharmaCompass.
Rocephine 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 Rocephine 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 Rocephine GMP manufacturer or Rocephine GMP API supplier for your needs.
A Rocephine CoA (Certificate of Analysis) is a formal document that attests to Rocephine's compliance with Rocephine specifications and serves as a tool for batch-level quality control.
Rocephine CoA mostly includes findings from lab analyses of a specific batch. For each Rocephine 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.
Rocephine may be tested according to a variety of international standards, such as European Pharmacopoeia (Rocephine EP), Rocephine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rocephine USP).
Comment (5)
