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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
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
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 : 29982
Submission : 2016-11-28
Status : Active
Type : II
Date of Issue : 2025-09-24
Valid Till : 2028-07-06
Written Confirmation Number : WC-0378
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4996
Submission : 1983-06-21
Status : Active
Type : II
Certificate Number : R1-CEP 2004-137 - Rev 04
Issue Date : 2016-09-02
Type : Chemical
Substance Number : 991
Status : Valid
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 : Kyungbo Pharmaceutical Co., Ltd.@[Product manufacturer] Sinopharm Weiqida Pharmaceutical Co. Ltd.@Henan Kangda Pharmaceutical Co., Ltd.
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do @ [Jopum Manufacturing Plant] 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 Fine Chemical Co., Ltd.
Registration Date : 2009-09-24
Registration Number : 20090924-127-G-28-02
Manufacturer Name : Hanmi Fine Chemical Co., Ltd.
Manufacturer Address : 57 Gyeongje-ro, Siheung-si, Gyeonggi-do
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 : 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
Registrant Name : HK Innoen Co., Ltd.
Registration Date : 2018-02-27
Registration Number : 20170413-116-G-139-13(4)
Manufacturer Name : Sinopharm Weiqida Pharmaceutical Co., Ltd.
Manufacturer Address : Economic & Technological Development Zone, First Medical Zone, Datong, Shanxi, China
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USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-21
DMF Number : 17541
Submission : 2004-07-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17259
Submission : 2004-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17824
Submission : 2004-10-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13656
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17884
Submission : 2004-12-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15931
Submission : 2002-03-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17714
Submission : 2004-09-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17257
Submission : 2004-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16467
Submission : 2003-03-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4996
Submission : 1983-06-21
Status : Active
Type : II
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 2004-137 - Rev 04
Status : Valid
Issue Date : 2016-09-02
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Registration Number : 221MF10275
Registrant's Address : CJ CheilJedang Building 292, Ssangnim-dong, Jung-gu, Seoul, 100-400, Korea
Initial Date of Registration : 2009-12-15
Latest Date of Registration : 2009-12-15
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 : 2018-01-19
Registration Number : 302MF10121
Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA
Initial Date of Registration : 2020-10-05
Latest Date of Registration : 2020-10-05
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 : 2021-01-05
Registration Number : 224MF10215
Registrant's Address : No. 98 Hainan Road, Economic and Technical Development Zone, Shijiazhuang, Hebei Prov...
Initial Date of Registration : 2012-11-12
Latest Date of Registration : 2017-12-21
Japanese Pharmacopoeia Ceftriaxone Sodium Hydrate
Registration Number : 231MF10043
Registrant's Address : No. 98 Hainan Road, Economic and Technical Development Zone, Shijiazhuang, Hebei Prov...
Initial Date of Registration : 2019-02-13
Latest Date of Registration : 2019-02-13
Japanese Pharmacopoeia Ceftriaxone Sodium Hydrate (For manufacturing purposes only)
Registration Number : 228MF10220
Registrant's Address : Village Saidpura, Tehsil Dera Bassi, District Sahibzada Ajit Singh Nagar-140 507, Pun...
Initial Date of Registration : 2016-11-22
Latest Date of Registration : 2022-07-13
Registration Number : 222MF10241
Registrant's Address : Orchid Towers, 313, Valuvar Kottam High Road, Nungambakkam, Chennai-600 034, India
Initial Date of Registration : 2010-10-13
Latest Date of Registration : 2010-10-13
Registration Number : 227MF10262
Registrant's Address : No. 849 Dongjia Town, Licheng District, Jinan, Shandong, China
Initial Date of Registration : 2015-11-11
Latest Date of Registration : 2015-11-11
Sterile Ceftriaxone Sodium Hydrate
Registration Number : 302MF10095
Registrant's Address : No. 849 Dongjia Town, Licheng District, Jinan, Shandong, China
Initial Date of Registration : 2020-08-05
Latest Date of Registration : 2020-08-05
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Cefotaxime Sodium (Sterile) USP
Date of Issue : 2022-08-31
Valid Till : 2025-07-14
Written Confirmation Number : WC-0090
Address of the Firm : MIs Kopran Research Laboratories Limited, K-4/4, Additional MIDC, Birwadi, Mahad...
Ceftriaxone Sodium USP/BP/Ph. Eur.
Date of Issue : 2022-11-18
Valid Till : 2025-08-06
Written Confirmation Number : WC-0145
Address of the Firm : Unit-ll, Village-Saidpura, Tehsil-Derabassi, District-Sahibzada Ajit Singh Nagar...
Ceftriaxone Sodium (Sterile) Ph.Eur.
Date of Issue : 2025-08-01
Valid Till : 2028-07-21
Written Confirmation Number : WC-0131
Address of the Firm : Plot No.121-128, 128A-133,138-151 & 159-164,\\nSIDCO Industrial Estate Alathur,\...
Ceftriaxone Sodium Sterile USP/EP/BP
Date of Issue : 2025-09-24
Valid Till : 2028-07-06
Written Confirmation Number : WC-0378
Address of the Firm : Plot No. 100, 118G, Sec-56, Phase-IV, HSIIDC, Kundli, Sonipat, Haryana, INDIA Ku...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2018-01-23
Registration Number : 20180123-116-G-147-14
Manufacturer Name : Kyungbo Pharmaceutical Co., ...
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do @ [Jopum Manufacturing Plant] Economic & Tec...
Registrant Name : Kangil Chemical Pharm Co., Ltd.
Registration Date : 2019-03-18
Registration Number : 20141117-116-G-125-11(5)
Manufacturer Name : NCPC Hebei Huamin Pharmaceut...
Manufacturer Address : No. 98 Hainan Road, Economic & Technological Development Zone, Shijiazhuang, China
Registrant Name : Korea Chorus Co., Ltd.
Registration Date : 2018-01-16
Registration Number : 20141117-116-G-125-11(4)
Manufacturer Name : NCPC Hebei Huamin Pharmaceut...
Manufacturer Address : No.98 Hainan Road, Economic & Technological Development Zone, Shijiazhuang, China
Registrant Name : Korea Union Pharmaceutical Co., Ltd.
Registration Date : 2023-05-15
Registration Number : 20130905-116-G-110-10(3)
Manufacturer Name : Quilu Antibiotics Pharmaceut...
Manufacturer Address : No.849 DongJia Town, Licheng District, Jinan, Shandong, China.
Registrant Name : Korea Union Pharmaceutical Co., Ltd.
Registration Date : 2020-03-17
Registration Number : 20130905-116-G-110-10(2)
Manufacturer Name : Qilu Antibiotics Pharmaceuti...
Manufacturer Address : No.849 Dongjia Town, Licheng District, Jinan, Shandong Province, China
Registrant Name : Saintek Pharma Co., Ltd.
Registration Date : 2020-04-27
Registration Number : 20200427-116-G-160-15
Manufacturer Name : Reyoung Pharmaceutical Co., ...
Manufacturer Address : No.1, Ruiyang Road, Yiyuan County, Shandong Province, China
Registrant Name : HK Innoen Co., Ltd.
Registration Date : 2018-02-27
Registration Number : 20170413-116-G-139-13(4)
Manufacturer Name : Sinopharm Weiqida Pharmaceut...
Manufacturer Address : Economic & Technological Development Zone, First Medical Zone, Datong, Shanxi, China
Registrant Name : Daesung Pharmtech Co., Ltd.
Registration Date : 2018-02-09
Registration Number : 20170413-116-G-139-13(3)
Manufacturer Name : Sinopharm Weiqida Pharmaceut...
Manufacturer Address : Economic & Technological Development Zone, First Medical Zone, Datong, Shanxi, China
Registrant Name : International Pharmaceutical Co., Ltd.
Registration Date : 2019-01-21
Registration Number : 20170413-116-G-139-13(6)
Manufacturer Name : Sinopharm Weiqida Pharmaceut...
Manufacturer Address : Economic&Technological Development Zone, First Medical Zone, Datong, Shanxi, China
Registrant Name : Sechang International Co., Ltd.
Registration Date : 2018-07-16
Registration Number : 20170413-116-G-139-13(5)
Manufacturer Name : Sinopharm Weiqida Pharmaceut...
Manufacturer Address : Economic & Technological Development Zone, First Medical Zone, Datong, Shanxi, China
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ABOUT THIS PAGE
14
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-ACT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 7-ACT, including repackagers and relabelers. The FDA regulates 7-ACT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 7-ACT 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-ACT manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 7-ACT supplier is an individual or a company that provides 7-ACT active pharmaceutical ingredient (API) or 7-ACT finished formulations upon request. The 7-ACT suppliers may include 7-ACT API manufacturers, exporters, distributors and traders.
click here to find a list of 7-ACT suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 7-ACT DMF (Drug Master File) is a document detailing the whole manufacturing process of 7-ACT active pharmaceutical ingredient (API) in detail. Different forms of 7-ACT DMFs exist exist since differing nations have different regulations, such as 7-ACT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 7-ACT DMF submitted to regulatory agencies in the US is known as a USDMF. 7-ACT USDMF includes data on 7-ACT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 7-ACT USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 7-ACT 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-ACT Drug Master File in Japan (7-ACT JDMF) empowers 7-ACT 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-ACT JDMF during the approval evaluation for pharmaceutical products. At the time of 7-ACT 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-ACT 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-ACT Drug Master File in Korea (7-ACT KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 7-ACT. The MFDS reviews the 7-ACT KDMF as part of the drug registration process and uses the information provided in the 7-ACT KDMF to evaluate the safety and efficacy of the drug.
After submitting a 7-ACT 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-ACT API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 7-ACT suppliers with KDMF on PharmaCompass.
A 7-ACT CEP of the European Pharmacopoeia monograph is often referred to as a 7-ACT Certificate of Suitability (COS). The purpose of a 7-ACT CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 7-ACT EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 7-ACT to their clients by showing that a 7-ACT CEP has been issued for it. The manufacturer submits a 7-ACT CEP (COS) as part of the market authorization procedure, and it takes on the role of a 7-ACT CEP holder for the record. Additionally, the data presented in the 7-ACT CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 7-ACT DMF.
A 7-ACT CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 7-ACT 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-ACT suppliers with CEP (COS) on PharmaCompass.
A 7-ACT written confirmation (7-ACT WC) is an official document issued by a regulatory agency to a 7-ACT manufacturer, verifying that the manufacturing facility of a 7-ACT active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 7-ACT APIs or 7-ACT finished pharmaceutical products to another nation, regulatory agencies frequently require a 7-ACT WC (written confirmation) as part of the regulatory process.
click here to find a list of 7-ACT 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 7-ACT as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 7-ACT 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-ACT 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-ACT and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 7-ACT NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 7-ACT suppliers with NDC on PharmaCompass.
7-ACT 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-ACT 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-ACT GMP manufacturer or 7-ACT GMP API supplier for your needs.
A 7-ACT CoA (Certificate of Analysis) is a formal document that attests to 7-ACT's compliance with 7-ACT specifications and serves as a tool for batch-level quality control.
7-ACT CoA mostly includes findings from lab analyses of a specific batch. For each 7-ACT 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-ACT may be tested according to a variety of international standards, such as European Pharmacopoeia (7-ACT EP), 7-ACT JP (Japanese Pharmacopeia) and the US Pharmacopoeia (7-ACT USP).
