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Chemistry

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Also known as: Ceftriaxone sodium, Ceftriaxone, 74578-69-1, 104376-79-6, Ro-139904, Ceftriaxone sodium salt
Molecular Formula
C18H17N8NaO7S3
Molecular Weight
576.6  g/mol
InChI Key
YOBPSXOHCHDCMU-VKZZUTNHSA-M

Ceftriaxone
A broad-spectrum cephalosporin antibiotic and cefotaxime derivative with a very long half-life and high penetrability to meninges, eyes and inner ears.
1 2D Structure

Ceftriaxone

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
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
2.1.2 InChI
InChI=1S/C18H18N8O7S3.Na/c1-25-18(22-12(28)13(29)23-25)36-4-6-3-34-15-9(14(30)26(15)10(6)16(31)32)21-11(27)8(24-33-2)7-5-35-17(19)20-7;/h5,9,15H,3-4H2,1-2H3,(H2,19,20)(H,21,27)(H,23,29)(H,31,32);/q;+1/p-1/b24-8-;/t9-,15-;/m1./s1
2.1.3 InChI Key
YOBPSXOHCHDCMU-VKZZUTNHSA-M
2.1.4 Canonical SMILES
CN1C(=NC(=O)C(=O)N1)SCC2=C(N3C(C(C3=O)NC(=O)C(=NOC)C4=CSC(=N4)N)SC2)C(=O)[O-].[Na+]
2.1.5 Isomeric SMILES
CN1C(=NC(=O)C(=O)N1)SCC2=C(N3[C@@H]([C@@H](C3=O)NC(=O)/C(=N\OC)/C4=CSC(=N4)N)SC2)C(=O)[O-].[Na+]
2.2 Synonyms
2.2.1 MeSH Synonyms

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

2.2.2 Depositor-Supplied Synonyms

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

2.3 Create Date
2008-02-05
3 Chemical and Physical Properties
Molecular Weight 576.6 g/mol
Molecular Formula C18H17N8NaO7S3
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count13
Rotatable Bond Count8
Exact Mass576.02800271 g/mol
Monoisotopic Mass576.02800271 g/mol
Topological Polar Surface Area291 Ų
Heavy Atom Count37
Formal Charge0
Complexity1120
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameRocephin
PubMed HealthCeftriaxone (Injection)
Drug ClassesAntibiotic
Drug LabelRocephin 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 IngredientCeftriaxone sodium
Dosage FormInjectable
RouteInjection
Strengtheq 500mg base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyHoffmann La Roche

2 of 2  
Drug NameRocephin
PubMed HealthCeftriaxone (Injection)
Drug ClassesAntibiotic
Drug LabelRocephin 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 IngredientCeftriaxone sodium
Dosage FormInjectable
RouteInjection
Strengtheq 500mg base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyHoffmann La Roche

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Cephalosporins [CS]; Cephalosporin Antibacterial [EPC]
5.3 ATC Code

J - Antiinfectives for systemic use

J01 - Antibacterials for systemic use

J01D - Other beta-lactam antibacterials

J01DD - Third-generation cephalosporins

J01DD04 - Ceftriaxone


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NO 849 DONGJIA TOWN LICHENG DISTRICT JINAN CITY 250105 SHANDONG CHINA SDNF","customerAddress":"621 RING ROAD MALL, SECTOR-3"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740421800,"product":"CEFTRIAXONE SODIUM NON STERILE (IP) CEFTRIAXONE SODIUM NON STERILE (IP)","address":"M-134, 2ND FLOOR","city":"NEW DELHI","supplier":"LIZHU PHARMACEUTICAL TRADING ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"RAJASTHAN ANTIBIOTICS","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"68","totalValueFC":"686145.3","currency":"N\/A","unitRateINR":"5967","date":"25-Feb-2025","totalValueINR":"59670000","totalValueInUsd":"686145.3","indian_port":"JNPT","hs_no":"29419090","bill_no":"8560791","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Non-sterile","supplierPort":"SHANGHAI","supplierAddress":"ROOM 513, 515-517, FLOOR 5 ADMIN BU ILDING, LIVZON INDUSTRIAL PARK, NO. 38 CHUANGYE NORTH RD., JINWAN, ZHU China","customerAddress":"M-134, 2ND FLOOR"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741113000,"product":"CEFTRIAXONE SODIUM STERILE USP CEFTRIAXONE SODIUM STERILE USP","address":"S.C.O.857, CABIN NO. 10, 2ND FLOOR,","city":"CHANDIGARH.","supplier":"LIZHU PHARMACEUTICAL TRADING ","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"VENUS REMEDIES","customerCountry":"INDIA","quantity":"1500.00","actualQuantity":"1500","unit":"KGS","unitRateFc":"83.5","totalValueFC":"126887.5","currency":"USD","unitRateINR":"7327.1","date":"05-Mar-2025","totalValueINR":"10990687.5","totalValueInUsd":"126887.5","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"8713736","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"CHENGDU","supplierAddress":"NORTH GUIHUA ROAD GONGBEI ZHUHAI CH INA 519020 , , CHINA SDNF CHINA","customerAddress":"S.C.O.857, CABIN NO. 10, 2ND FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741285800,"product":"CEFTRIAXONE SODIUM (NON-STERILE) I.P CHEMICAL","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"NUTRAINNO HONGKONG LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"8922.00","actualQuantity":"8922","unit":"KGS","unitRateFc":"68","totalValueFC":"614978","currency":"USD","unitRateINR":"5970.4","date":"07-Mar-2025","totalValueINR":"53267908.8","totalValueInUsd":"614978","indian_port":"Madras Sea","hs_no":"29419090","bill_no":"8752887","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Non-sterile","supplierPort":"SHANGHAI","supplierAddress":"SHOP 185G\/F HANG WAI IND CTR NO 6 K IN TAI ST TUEN MUN NT HONGKONG CHIN A, , CHINA CHINA","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741285800,"product":"STERILE CEFTRIAXONE SODIUM BP\/USP STERILE CEFTRIAXONE SODIUM BP\/USP","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"QILU PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"8.00","actualQuantity":"8","unit":"KGS","unitRateFc":"180","totalValueFC":"1459.7","currency":"USD","unitRateINR":"15804","date":"07-Mar-2025","totalValueINR":"126432","totalValueInUsd":"1459.7","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"8749712","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"BEIJING","supplierAddress":"NO.849 DONGJIA TOWN LICHENG DISTRI CT JINAN CITY SDNF China","customerAddress":"101, SITARAM MANSION,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741285800,"product":"STERILE CEFTRIAXONE SODIUM BP\/USP STERILE CEFTRIAXONE SODIUM BP\/USP","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"QILU PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"32.00","actualQuantity":"32","unit":"KGS","unitRateFc":"180","totalValueFC":"5838.6","currency":"USD","unitRateINR":"15804","date":"07-Mar-2025","totalValueINR":"505728","totalValueInUsd":"5838.6","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"8749712","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"BEIJING","supplierAddress":"NO.849 DONGJIA TOWN LICHENG DISTRI CT JINAN CITY SDNF China","customerAddress":"101, SITARAM MANSION,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741631400,"product":"CEFTRIAXONE SODIUM STERILE USP CEFTRIAXONE SODIUM STERILE USP","address":"S.C.O.857, CABIN NO. 10, 2ND FLOOR,","city":"CHANDIGARH.","supplier":"LIZHU PHARMACEUTICAL TRADING ","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"VENUS REMEDIES","customerCountry":"INDIA","quantity":"465.00","actualQuantity":"465","unit":"KGS","unitRateFc":"83","totalValueFC":"39121.9","currency":"USD","unitRateINR":"7287.4","date":"11-Mar-2025","totalValueINR":"3388641","totalValueInUsd":"39121.9","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"8815761","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"CHENGDU","supplierAddress":"NORTH GUIHUA ROAD GONGBEI ZHUHAI CH INA 519020 , , CHINA SDNF CHINA","customerAddress":"S.C.O.857, CABIN NO. 10, 2ND FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741631400,"product":"CEFTRIAXONE SODIUM STERILE USP CEFTRIAXONE SODIUM STERILE USP","address":"S.C.O.857, CABIN NO. 10, 2ND FLOOR,","city":"CHANDIGARH.","supplier":"LIZHU PHARMACEUTICAL TRADING ","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"VENUS REMEDIES","customerCountry":"INDIA","quantity":"735.00","actualQuantity":"735","unit":"KGS","unitRateFc":"83","totalValueFC":"61837.8","currency":"USD","unitRateINR":"7287.4","date":"11-Mar-2025","totalValueINR":"5356239","totalValueInUsd":"61837.8","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"8815761","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"CHENGDU","supplierAddress":"NORTH GUIHUA ROAD GONGBEI ZHUHAI CH INA 519020 , , CHINA SDNF CHINA","customerAddress":"S.C.O.857, CABIN NO. 10, 2ND FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741804200,"product":"CEFTRIAXONE SODIUM (NON STERILE) IP CEFTRIAXONE SODIUM (NON STERILE) IP","address":"M-134, 2ND FLOOR","city":"NEW DELHI","supplier":"SHANDONG XINQUAN PHARMACEUTICAL CO., LTD","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"RAJASTHAN ANTIBIOTICS","customerCountry":"INDIA","quantity":"10000.00","actualQuantity":"10000","unit":"KGS","unitRateFc":"68","totalValueFC":"689282.7","currency":"USD","unitRateINR":"5970.4","date":"13-Mar-2025","totalValueINR":"59704000","totalValueInUsd":"689282.7","indian_port":"JNPT","hs_no":"29419090","bill_no":"8870025","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Non-sterile","supplierPort":"QINGDAO","supplierAddress":"ECONOMIC DEVELOPMENT ZONE, YIYUAN C OUNTY, ZIBO CITY, SHANDONG PROVINCE SDNF China","customerAddress":"M-134, 2ND FLOOR"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742754600,"product":"CEFTRIAXONE SODIUM (NON-STERILE) CEFTRIAXONE SODIUM (NON-STERILE)","address":"1705, 4TH FLOOR, ONKAR BHAWAN","city":"DELHI","supplier":"HENAN KANGDA PHARMACEUTICAL CO., LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"STERILE INDIA PVT. LTD","customerCountry":"INDIA","quantity":"4606.95","actualQuantity":"4606.948","unit":"KGS","unitRateFc":"65","totalValueFC":"301810.8","currency":"USD","unitRateINR":"5674.5","date":"24-Mar-2025","totalValueINR":"26142126.43","totalValueInUsd":"301810.8","indian_port":"JNPT","hs_no":"29419090","bill_no":"9062724","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Non-sterile","supplierPort":"SHANGHAI","supplierAddress":"NO.66, JINGWU ROAD, XIANGCHENG CITY , HENAN PROVINCE, CHINA CHINA, , CH INA CHINA","customerAddress":"1705, 4TH FLOOR, ONKAR BHAWAN"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742927400,"product":"CEFTRIAXONE SODIUM STERILE USP CEFTRIAXONE SODIUM STERILE USP","address":"3RD FLOOR, AVM TOWERS, BESIDE","city":"KUKATPALLY, HYDERABAD.AP","supplier":"CHINA SINOPHARM INTERNATIONAL CORP.","supplierCountry":"CHINA","foreign_port":"XINGANG (CHINA)","customer":"YELURI FORMULATIONS PRIVATE ","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"79","totalValueFC":"3981.1","currency":"USD","unitRateINR":"6896.7","date":"26-Mar-2025","totalValueINR":"344835","totalValueInUsd":"3981.1","indian_port":"Madras Sea","hs_no":"29419090","bill_no":"9115668","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"XINGANG (CHINA)","supplierAddress":"ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHANXI,CHINA CHINA","customerAddress":"3RD FLOOR, AVM TOWERS, BESIDE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742927400,"product":"CEFTRIAXONE SODIUM STERILE USP CEFTRIAXONE SODIUM STERILE USP","address":"3RD FLOOR, AVM TOWERS, BESIDE","city":"KUKATPALLY, HYDERABAD.AP","supplier":"CHINA SINOPHARM INTERNATIONAL CORP.","supplierCountry":"CHINA","foreign_port":"XINGANG (CHINA)","customer":"YELURI FORMULATIONS PRIVATE ","customerCountry":"INDIA","quantity":"3050.00","actualQuantity":"3050","unit":"KGS","unitRateFc":"79","totalValueFC":"242848.3","currency":"USD","unitRateINR":"6896.7","date":"26-Mar-2025","totalValueINR":"21034935","totalValueInUsd":"242848.3","indian_port":"Madras Sea","hs_no":"29419090","bill_no":"9115668","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Sterile","supplierPort":"XINGANG (CHINA)","supplierAddress":"ECONOMIC AND TECHNOLOGICAL DEVELOPMENT ZONE, SHANXI,CHINA CHINA","customerAddress":"3RD FLOOR, AVM TOWERS, BESIDE"}]
01-Jan-2021
29-Mar-2025
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ABOUT THIS PAGE

Looking for 104376-79-6 / Ceftriaxone API manufacturers, exporters & distributors?

Ceftriaxone manufacturers, exporters & distributors 1

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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.

API | Excipient name

Ceftriaxone

Synonyms

Ceftriaxone sodium, 74578-69-1, 104376-79-6, Ro-139904, Ceftriaxone sodium salt, Octx

Cas Number

104376-79-6

About Ceftriaxone

A broad-spectrum cephalosporin antibiotic and cefotaxime derivative with a very long half-life and high penetrability to meninges, eyes and inner ears.

Rocefin Manufacturers

A Rocefin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rocefin, including repackagers and relabelers. The FDA regulates Rocefin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rocefin 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 Rocefin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Rocefin Suppliers

A Rocefin supplier is an individual or a company that provides Rocefin active pharmaceutical ingredient (API) or Rocefin finished formulations upon request. The Rocefin suppliers may include Rocefin API manufacturers, exporters, distributors and traders.

click here to find a list of Rocefin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Rocefin USDMF

A Rocefin DMF (Drug Master File) is a document detailing the whole manufacturing process of Rocefin active pharmaceutical ingredient (API) in detail. Different forms of Rocefin DMFs exist exist since differing nations have different regulations, such as Rocefin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Rocefin DMF submitted to regulatory agencies in the US is known as a USDMF. Rocefin USDMF includes data on Rocefin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rocefin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Rocefin suppliers with USDMF on PharmaCompass.

Rocefin JDMF

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 Rocefin Drug Master File in Japan (Rocefin JDMF) empowers Rocefin 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 Rocefin JDMF during the approval evaluation for pharmaceutical products. At the time of Rocefin 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 Rocefin suppliers with JDMF on PharmaCompass.

Rocefin KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Rocefin Drug Master File in Korea (Rocefin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rocefin. The MFDS reviews the Rocefin KDMF as part of the drug registration process and uses the information provided in the Rocefin KDMF to evaluate the safety and efficacy of the drug.

After submitting a Rocefin 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 Rocefin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Rocefin suppliers with KDMF on PharmaCompass.

Rocefin CEP

A Rocefin CEP of the European Pharmacopoeia monograph is often referred to as a Rocefin Certificate of Suitability (COS). The purpose of a Rocefin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rocefin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rocefin to their clients by showing that a Rocefin CEP has been issued for it. The manufacturer submits a Rocefin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rocefin CEP holder for the record. Additionally, the data presented in the Rocefin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rocefin DMF.

A Rocefin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rocefin 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 Rocefin suppliers with CEP (COS) on PharmaCompass.

Rocefin WC

A Rocefin written confirmation (Rocefin WC) is an official document issued by a regulatory agency to a Rocefin manufacturer, verifying that the manufacturing facility of a Rocefin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rocefin APIs or Rocefin finished pharmaceutical products to another nation, regulatory agencies frequently require a Rocefin WC (written confirmation) as part of the regulatory process.

click here to find a list of Rocefin suppliers with Written Confirmation (WC) on PharmaCompass.

Rocefin NDC

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 Rocefin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Rocefin API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Rocefin 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Rocefin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rocefin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Rocefin suppliers with NDC on PharmaCompass.

Rocefin GMP

Rocefin 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 Rocefin 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 Rocefin GMP manufacturer or Rocefin GMP API supplier for your needs.

Rocefin CoA

A Rocefin CoA (Certificate of Analysis) is a formal document that attests to Rocefin's compliance with Rocefin specifications and serves as a tool for batch-level quality control.

Rocefin CoA mostly includes findings from lab analyses of a specific batch. For each Rocefin 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.

Rocefin may be tested according to a variety of international standards, such as European Pharmacopoeia (Rocefin EP), Rocefin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rocefin USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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