Synopsis
Synopsis
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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
API SUPPLIERS
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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 2014-213 - Rev 01
Issue Date : 2025-03-26
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_
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-27
Pay. Date : 2013-09-19
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
DMF Review : Reviewed
Rev. Date : 2014-01-06
Pay. Date : 2013-09-27
DMF Number : 26047
Submission : 2012-06-08
Status : Active
Type : II
Certificate Number : R1-CEP 2008-124 - Rev 00
Issue Date : 2015-11-20
Type : Chemical
Substance Number : 1188
Status : Withdrawn by EDQM F...
Date of Issue : 2015-08-25
Valid Till : 2018-08-25
Written Confirmation Number : WC-0342
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-29
Pay. Date : 2014-02-25
DMF Number : 23474
Submission : 2010-01-18
Status : Active
Type : II
Date of Issue : 2022-05-17
Valid Till : 2025-05-16
Written Confirmation Number : WC-0008
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25390
Submission : 2011-09-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27033
Submission : 2013-04-03
Status : Inactive
Type : II
Certificate Number : R0-CEP 2014-217 - Rev 00
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
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9478
Submission : 1991-12-31
Status : Inactive
Type : II
Certificate Number : R1-CEP 2001-073 - Rev 00
Issue Date : 2006-07-13
Type : TSE
Substance Number : 1188
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13687
Submission : 1998-09-01
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
Certificate Number : R1-CEP 1999-158 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2007-04-04
Type : Chemical
Substance Number : 1188
Certificate Number : R1-CEP 2001-073 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2006-07-13
Type : TSE
Substance Number : 1188
Certificate Number : R1-CEP 2003-014 - Rev 02
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2014-06-02
Type : Chemical
Substance Number : 1188
Certificate Number : R0-CEP 2014-217 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2016-12-02
Type : Chemical
Substance Number : 1188
Certificate Number : R0-CEP 2004-123 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2007-08-01
Type : Chemical
Substance Number : 1188
Certificate Number : R1-CEP 2011-239 - Rev 00
Status : Suspended by EDQM GMP non-compliance
Issue Date : 2019-03-08
Type : Chemical
Substance Number : 1188
Certificate Number : R1-CEP 2009-347 - Rev 02
Status : Valid
Issue Date : 2018-10-31
Type : Chemical
Substance Number : 1188
Certificate Number : R0-CEP 2010-192 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2014-01-08
Type : Chemical
Substance Number : 1188
Certificate Number : R1-CEP 2001-449 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2008-05-14
Type : Chemical
Substance Number : 1188
Certificate Number : R0-CEP 2007-314 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2010-01-21
Type : Chemical
Substance Number : 1188
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
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...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company comme...
About the Company : HENGDIAN GROUP was established in 1975, till now it has become a transnational,conglomerate group and been one of the largest private-owned enterprises in China. The Pharmaceutical...
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 : 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...
About the Company : QINGDAO QINGMEI BIOTECH(hereinafter referred to as Qingmei) is a specialized pharmaceutical company founded by DAYON INTERNATIONAL HOLDING LIMITED, which is to expand international...
About the Company : Sichuan Renan Pharmaceutical Co., Ltd., founded in June 2013 with 325 acres and more than 1000 employees , located in Yuechi Pharmaceutical Industrial Park, Guangan city Sichuan pr...
About the Company : SNEHA MEDICARE PVT LTD., one of the pioneers in API sourcing and supply in India, was established in 1985 by Shri. Kirti M Shah in the name of SNEHA CHEMICALS, which was later chan...
About the Company : Suzhou Tianlu Bio-pharmaceutical Co.,Ltd., established in Dec.1999 covering an area of 26,666 square meters, is a high-tech shareholding company with a total investment of one hund...
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 
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]DRUG PRODUCT COMPOSITIONS
DOSAGE - FOR SUSPENSION;ORAL - 500MG/5ML
USFDA APPLICATION NUMBER - 202091
DOSAGE - CAPSULE;ORAL - 400MG
USFDA APPLICATION NUMBER - 203195
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
Coating Systems & Additives
Thickeners and Stabilizers
Direct Compression
Controlled & Modified Release
Taste Masking
Granulation
Chewable & Orodispersible Aids
Co-Processed Excipients
Topical
Disintegrants & Superdisintegrants
Lubricants & Glidants
Film Formers & Plasticizers
Empty Capsules
Solubilizers
Parenteral
Rheology Modifiers
Emulsifying Agents
API Stability Enhancers
Coloring Agents
Vegetarian Capsules
Surfactant & Foaming Agents
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
APIs
Reply
23 Apr 2025
Reply
01 Apr 2025
Reply
02 Jan 2025
Reply
19 Nov 2024
Reply
18 Sep 2024
Reply
19 Feb 2024
Reply
22 Nov 2023
Reply
05 Oct 2023
Reply
21 Sep 2023
Reply
04 Aug 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
95
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 Cefspan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefspan, including repackagers and relabelers. The FDA regulates Cefspan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefspan 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 Cefspan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefspan supplier is an individual or a company that provides Cefspan active pharmaceutical ingredient (API) or Cefspan finished formulations upon request. The Cefspan suppliers may include Cefspan API manufacturers, exporters, distributors and traders.
click here to find a list of Cefspan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cefspan DMF (Drug Master File) is a document detailing the whole manufacturing process of Cefspan active pharmaceutical ingredient (API) in detail. Different forms of Cefspan DMFs exist exist since differing nations have different regulations, such as Cefspan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cefspan DMF submitted to regulatory agencies in the US is known as a USDMF. Cefspan USDMF includes data on Cefspan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cefspan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cefspan 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 Cefspan Drug Master File in Japan (Cefspan JDMF) empowers Cefspan 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 Cefspan JDMF during the approval evaluation for pharmaceutical products. At the time of Cefspan 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 Cefspan 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 Cefspan Drug Master File in Korea (Cefspan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cefspan. The MFDS reviews the Cefspan KDMF as part of the drug registration process and uses the information provided in the Cefspan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Cefspan 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 Cefspan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Cefspan suppliers with KDMF on PharmaCompass.
A Cefspan CEP of the European Pharmacopoeia monograph is often referred to as a Cefspan Certificate of Suitability (COS). The purpose of a Cefspan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cefspan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cefspan to their clients by showing that a Cefspan CEP has been issued for it. The manufacturer submits a Cefspan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cefspan CEP holder for the record. Additionally, the data presented in the Cefspan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cefspan DMF.
A Cefspan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cefspan 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 Cefspan suppliers with CEP (COS) on PharmaCompass.
A Cefspan written confirmation (Cefspan WC) is an official document issued by a regulatory agency to a Cefspan manufacturer, verifying that the manufacturing facility of a Cefspan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cefspan APIs or Cefspan finished pharmaceutical products to another nation, regulatory agencies frequently require a Cefspan WC (written confirmation) as part of the regulatory process.
click here to find a list of Cefspan 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 Cefspan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cefspan 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 Cefspan 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 Cefspan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefspan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cefspan suppliers with NDC on PharmaCompass.
Cefspan 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 Cefspan 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 Cefspan GMP manufacturer or Cefspan GMP API supplier for your needs.
A Cefspan CoA (Certificate of Analysis) is a formal document that attests to Cefspan's compliance with Cefspan specifications and serves as a tool for batch-level quality control.
Cefspan CoA mostly includes findings from lab analyses of a specific batch. For each Cefspan 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.
Cefspan may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefspan EP), Cefspan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefspan USP).
Comment (1)
