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1. Cefixime
2. Cefixime Anhydrous
3. Cefixime Trihydrate
4. Fk 027
5. Fk-027
6. Fk027
7. Fr 17027
8. Fr-17027
9. Fr17027
1. Cefixime
2. 97164-56-2
3. 79350-37-1
4. Cefixime(e)-form
5. (e)-cefixime
6. Cefixime Anhydrous, (e)-
7. U7rwt9j78o
8. Cfix
9. (6r,7r)-7-(((2e)-2-(2-amino-4-thiazolyl)-2-((carboxymethoxy)imino)acetyl)amino)-3-ethenyl-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid
10. (6r,7r)-7-[[(2e)-2-(2-amino-1,3-thiazol-4-yl)-2-(carboxymethoxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
11. 5-thia-1-azabicyclo(4.2.0)oct-2-ene-2-carboxylic Acid, 7-(((2e)-2-(2-amino-4-thiazolyl)-2-((carboxymethoxy)imino)acetyl)amino)-3-ethenyl-8-oxo-, (6r,7r)-
12. Cefixime Impurity D
13. Unii-u7rwt9j78o
14. (6r,7r)-7-[[(2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(carboxymethoxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
15. Cefiximetrihydrate
16. Prestwick2_000462
17. Epitope Id:116227
18. Schembl24946
19. Schembl49534
20. Chembl427069
21. Bdbm88962
22. Chebi:93248
23. Gtpl10898
24. Cid_56642849
25. Hms1569m06
26. (6r,7r)-7-((z)-2-(2-aminothiazol-4-yl)-2-((carboxymethoxy)imino)acetamido)-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
27. Zinc4468778
28. Ncgc00185001-01
29. (e)-cefixime (cefixime Ep Impurity D)
30. Q163901
31. J-005196
32. J-501698
33. Brd-k04993501-001-01-9
34. [6r-[6alpha,7beta(e)]]-7-[[(2-amino-4-thiazolyl)[(car
35. (6r,7r)-7-[[(2e)-2-(2-amino-1,3-thiazol-4-yl)-2-(carboxymethoxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid;hydrate
36. (6r,7r)-7-[[(2e)-2-(2-amino-4-thiazolyl)-2-(carboxymethoxyimino)-1-oxoethyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid;hydrate
37. (6r,7r)-7-[[(2e)-2-(2-aminothiazol-4-yl)-2-(carboxymethyloximino)acetyl]amino]-8-keto-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid;hydrate
38. (6r,7r)-7-[[(2e)-2-(2-azanyl-1,3-thiazol-4-yl)-2-(2-hydroxy-2-oxoethyloxyimino)ethanoyl]amino]-3-ethenyl-8-oxidanylidene-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid;hydrate
39. (6r,7r)-7-[[(2z)-2-(2-amino-thiazol-4-yl)-2-[(carboxymethoxy)imino]acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene -2-carboxylic Acid
40. (6r,7r,e)-7-(2-(2-aminothiazol-4-yl)-2-(carboxymethoxyimino)acetamido)-8-oxo-3-vinyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid
| Molecular Weight | 453.5 g/mol |
|---|---|
| Molecular Formula | C16H15N5O7S2 |
| XLogP3 | -0.7 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 8 |
| Exact Mass | 453.04129018 g/mol |
| Monoisotopic Mass | 453.04129018 g/mol |
| Topological Polar Surface Area | 238 Ų |
| Heavy Atom Count | 30 |
| Formal Charge | 0 |
| Complexity | 861 |
| 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 | 1 |
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
J01DD08 - Cefixime
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41651
Submission : 2025-03-27
Status : Active
Type : II
Certificate Number : CEP 2019-162 - Rev 01
Issue Date : 2024-07-19
Type : Chemical
Substance Number : 1188
Status : Valid
Registration Number : 302MF10060
Registrant's Address : No. 519 Jiangnan Road, Hengdian Industrial Zone, Dongyang City, Jinhua, Zhejiang Province, China
Initial Date of Registration : 2020-05-25
Latest Date of Registration :

GDUFA
DMF Review : Reviewed
Rev. Date : 2022-11-28
Pay. Date : 2022-08-19
DMF Number : 36694
Submission : 2022-07-22
Status : Active
Type : II
Certificate Number : CEP 2021-361 - Rev 01
Issue Date : 2025-06-19
Type : Chemical
Substance Number : 1188
Status : Valid
Registration Number : 226MF10199
Registrant's Address : No. 849 Dongjia Town, Licheng District, Jinan, Shandong, China
Initial Date of Registration : 2014-10-27
Latest Date of Registration :
Registrant Name : Seongi Bio Co., Ltd.
Registration Date : 2015-05-15
Registration Number : 20150515-26-A-318-10
Manufacturer Name : Qilu Antibiotics Pharmaceutical Co., Ltd
Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, China_x000D_

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DMF Number : 27527
Submission : 2013-09-27
Status : Active
Type : II
Certificate Number : R0-CEP 2010-192 - Rev 00
Issue Date : 2014-01-08
Type : Chemical
Substance Number : 1188
Status : Withdrawn by Holder

GDUFA
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Rev. Date : 2014-07-29
Pay. Date : 2014-02-25
DMF Number : 23474
Submission : 2010-01-18
Status : Active
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Valid Till : 2025-05-16
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DMF Number : 27033
Submission : 2013-04-03
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Issue Date : 2016-12-02
Type : Chemical
Substance Number : 1188
Status : Withdrawn by Holder
Registration Number : 224MF10092
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2012-04-25
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Certificate Number : R1-CEP 2001-073 - Rev 00
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Type : TSE
Substance Number : 1188
Status : Withdrawn by Holder

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Issue Date : 2018-10-31
Type : Chemical
Substance Number : 1188
Status : Valid

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Pay. Date :
DMF Number : 9478
Submission : 1991-12-31
Status : Inactive
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Submission : 2002-05-20
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GDUFA
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Type : II

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Certificate Number : R1-CEP 1999-158 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2007-04-04
Type : Chemical
Substance Number : 1188

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Substance Number : 1188

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Certificate Number : R1-CEP 2003-014 - Rev 02
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Substance Number : 1188

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Substance Number : 1188

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Status : Suspended by EDQM GMP non-compliance
Issue Date : 2019-03-08
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Substance Number : 1188

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Issue Date : 2018-10-31
Type : Chemical
Substance Number : 1188

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Status : Withdrawn by Holder
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Substance Number : 1188

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Substance Number : 1188

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Certificate Number : R0-CEP 2007-314 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2010-01-21
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Substance Number : 1188

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Latest Date of Registration : 2012-04-25

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Details:
Cefixime is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Gonorrhea.
Lead Product(s): Cefixime,Azithromycin,Doxycycline
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Aurum Institute | Nyanza Reproductive Health Society | Partners for Health and Development in Africa | National Institute of Allergy and Infectious Diseases
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 21, 2024

Lead Product(s) : Cefixime,Azithromycin,Doxycycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Aurum Institute | Nyanza Reproductive Health Society | Partners for Health and Development in Africa | National Institute of Allergy and Infectious Diseases
Deal Size : Inapplicable
Deal Type : Inapplicable
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Details : Cefixime is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Gonorrhea.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 21, 2024

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Details:
Cefixime Trihydrate is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Substance-Related Disorders.
Lead Product(s): Cefixime,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Miscellaneous
Sponsor: Pharma Metric Labs
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 29, 2021

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Lead Product(s) : Cefixime,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Pharma Metric Labs
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers
Details : Cefixime Trihydrate is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Substance-Related Disorders.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 29, 2021

Details:
Cefixime is a Other Small Molecule drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Syphilis.
Lead Product(s): Cefixime,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 23, 2018

Lead Product(s) : Cefixime,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cefixime is a Other Small Molecule drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Syphilis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 23, 2018

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Details:
SKF101804 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Bacterial Infections.
Lead Product(s): SKF101804,Cefixime
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 24, 2018

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Lead Product(s) : SKF101804,Cefixime
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SKF101804 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Bacterial Infections.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
January 24, 2018

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Details:
Cefixime is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Bacterial Infections.
Lead Product(s): Cefixime,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 06, 2017

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Cefixime,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Cefixime is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Bacterial Infections.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 06, 2017

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PharmaCompass offers a list of Cefixime 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 Cefixime manufacturer or Cefixime supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefixime manufacturer or Cefixime supplier.
PharmaCompass also assists you with knowing the Cefixime API Price utilized in the formulation of products. Cefixime API Price is not always fixed or binding as the Cefixime Price is obtained through a variety of data sources. The Cefixime Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cefiximum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefiximum, including repackagers and relabelers. The FDA regulates Cefiximum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefiximum 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 Cefiximum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefiximum supplier is an individual or a company that provides Cefiximum active pharmaceutical ingredient (API) or Cefiximum finished formulations upon request. The Cefiximum suppliers may include Cefiximum API manufacturers, exporters, distributors and traders.
click here to find a list of Cefiximum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefiximum DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefiximum active pharmaceutical ingredient (API) in detail. Different forms of Cefiximum DMFs exist exist since differing nations have different regulations, such as Cefiximum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefiximum DMF submitted to regulatory agencies in the US is known as a USDMF. Cefiximum USDMF includes data on Cefiximum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefiximum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefiximum 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 Cefiximum Drug Master File in Japan (Cefiximum JDMF) empowers Cefiximum 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 Cefiximum JDMF during the approval evaluation for pharmaceutical products. At the time of Cefiximum 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 Cefiximum 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 Cefiximum Drug Master File in Korea (Cefiximum KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefiximum. The MFDS reviews the Cefiximum KDMF as part of the drug registration process and uses the information provided in the Cefiximum KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cefiximum 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 Cefiximum API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cefiximum suppliers with KDMF on PharmaCompass.
A Cefiximum CEP of the European Pharmacopoeia monograph is often referred to as a Cefiximum Certificate of Suitability (COS). The purpose of a Cefiximum CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefiximum EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefiximum to their clients by showing that a Cefiximum CEP has been issued for it. The manufacturer submits a Cefiximum CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefiximum CEP holder for the record. Additionally, the data presented in the Cefiximum CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefiximum DMF.
A Cefiximum CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefiximum 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 Cefiximum suppliers with CEP (COS) on PharmaCompass.
A Cefiximum written confirmation (Cefiximum WC) is an official document issued by a regulatory agency to a Cefiximum manufacturer, verifying that the manufacturing facility of a Cefiximum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefiximum APIs or Cefiximum finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefiximum WC (written confirmation) as part of the regulatory process.
click here to find a list of Cefiximum 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 Cefiximum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefiximum 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 Cefiximum 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 Cefiximum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefiximum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefiximum suppliers with NDC on PharmaCompass.
Cefiximum 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 Cefiximum 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 Cefiximum GMP manufacturer or Cefiximum GMP API supplier for your needs.
A Cefiximum CoA (Certificate of Analysis) is a formal document that attests to Cefiximum's compliance with Cefiximum specifications and serves as a tool for batch-level quality control.
Cefiximum CoA mostly includes findings from lab analyses of a specific batch. For each Cefiximum 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.
Cefiximum may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefiximum EP), Cefiximum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefiximum USP).