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Chemistry

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Also known as: Cefixime, 97164-56-2, 79350-37-1, Cefixime(e)-form, (e)-cefixime, Cefixime anhydrous, (e)-
Molecular Formula
C16H15N5O7S2
Molecular Weight
453.5  g/mol
InChI Key
OKBVVJOGVLARMR-VINNURBNSA-N
FDA UNII
U7RWT9J78O

Cefixime
A third-generation cephalosporin antibiotic that is stable to hydrolysis by beta-lactamases.
1 2D Structure

Cefixime

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(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
2.1.2 InChI
InChI=1S/C16H15N5O7S2/c1-2-6-4-29-14-10(13(25)21(14)11(6)15(26)27)19-12(24)9(20-28-3-8(22)23)7-5-30-16(17)18-7/h2,5,10,14H,1,3-4H2,(H2,17,18)(H,19,24)(H,22,23)(H,26,27)/b20-9+/t10-,14-/m1/s1
2.1.3 InChI Key
OKBVVJOGVLARMR-VINNURBNSA-N
2.1.4 Canonical SMILES
C=CC1=C(N2C(C(C2=O)NC(=O)C(=NOCC(=O)O)C3=CSC(=N3)N)SC1)C(=O)O
2.1.5 Isomeric SMILES
C=CC1=C(N2[C@@H]([C@@H](C2=O)NC(=O)/C(=N/OCC(=O)O)/C3=CSC(=N3)N)SC1)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
U7RWT9J78O
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Cefixime

2. Cefixime Anhydrous

3. Cefixime Trihydrate

4. Fk 027

5. Fk-027

6. Fk027

7. Fr 17027

8. Fr-17027

9. Fr17027

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2005-11-20
3 Chemical and Physical Properties
Molecular Weight 453.5 g/mol
Molecular Formula C16H15N5O7S2
XLogP3-0.7
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count12
Rotatable Bond Count8
Exact Mass453.04129018 g/mol
Monoisotopic Mass453.04129018 g/mol
Topological Polar Surface Area238 Ų
Heavy Atom Count30
Formal Charge0
Complexity861
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

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


4.2 FDA Pharmacological Classification
4.2.1 Pharmacological Classes
Cephalosporins [CS]; Cephalosporin Antibacterial [EPC]
4.3 ATC Code

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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Certificate Number : R0-CEP 2014-217 - Rev 00

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Certificate Number : R0-CEP 2004-123 - Rev 00

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Cefixime hydrate

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 : 2012-04-25

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Cefixime

Registration Number : 222MF10120

Registrant's Address : Orchid Towers, 313, Valluvar Kottam High Road, Nungambakkam, Chennai-600 034 India

Initial Date of Registration : 2010-04-02

Latest Date of Registration : 2010-04-02

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Cefixime Hydrate

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 : 2023-08-02

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Cefixime hydrate

Registration Number : 302MF10060

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Initial Date of Registration : 2020-05-25

Latest Date of Registration : 2020-05-25

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API Reference Price

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CO","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"COVALENT LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"125.00","actualQuantity":"125","unit":"KGS","unitRateFc":"145","totalValueFC":"18763.2","currency":"USD","unitRateINR":"12534.9","date":"05-Apr-2024","totalValueINR":"1566861.88","totalValueInUsd":"18763.2","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"2888618","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"AMMAN","supplierAddress":"P.O.BOX 334, A1-JUBAIHAAMMAN 11941,JORDANSDNF JO","customerAddress":"8-3-677\/18, S.K.D.NAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720636200,"product":"CEFIXIME TRIHYDRATE (MICRONISED) (RE-IMPORT AFTER REJECTION)","address":"VILLAGE SAIDPURA,TEHSIL DERABASSI,","city":"MOHALI (PUNJAB)","supplier":"EIP ECZACIBASI ILAC PAZARLAMA AS","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"NECTAR LIFE SCIENCES LTD","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"175","totalValueFC":"36409.2","currency":"USD","unitRateINR":"15217.4","date":"11-Jul-2024","totalValueINR":"3043488.21","totalValueInUsd":"36409.2","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"4454877","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Micronized","supplierPort":"ISTANBUL","supplierAddress":"BUYUKDERE CAD ALI KAYA SOK NO.5 LEVENT 34394 ISTANBUL\/TURKEY Istanbul,, TURKEY TURKEY","customerAddress":"VILLAGE SAIDPURA,TEHSIL DERABASSI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720636200,"product":"CEFIXIME TRIHYDRATE (RE-IMPORT AFTER REJECTION)","address":"VILLAGE SAIDPURA,TEHSIL DERABASSI,","city":"MOHALI (PUNJAB)","supplier":"WORLD MEDICINE ILAC SAN VE TIC AS","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"NECTAR LIFE SCIENCES LTD","customerCountry":"INDIA","quantity":"450.00","actualQuantity":"450","unit":"KGS","unitRateFc":"175","totalValueFC":"81823.7","currency":"USD","unitRateINR":"15199.4","date":"11-Jul-2024","totalValueINR":"6839728.65","totalValueInUsd":"81823.7","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"4454396","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ISTANBUL","supplierAddress":"15 TEMMUZ MAH CAMI YOLU CAD NO. 50,WM PLAZA Istanbul - 34212, GUNESLI TURKEY","customerAddress":"VILLAGE SAIDPURA,TEHSIL DERABASSI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731609000,"product":"CEFIXIME(RE-IMPORT VIDE SB NO:3466100 DT:24.08.2024)","address":"8-3-677\/18, S.K.D.NAGAR","city":"HYDERABAD.AP","supplier":"PHARMA INTERNATIONAL CO","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"COVALENT LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"1600.00","actualQuantity":"1600","unit":"KGS","unitRateFc":"145","totalValueFC":"238070.2","currency":"USD","unitRateINR":"12556.4","date":"15-Nov-2024","totalValueINR":"20090308.09","totalValueInUsd":"238070.2","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"6685464","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"AMMAN","supplierAddress":"148,QUEEN RANIA STR-ABU ALHAJ,JO-11941,COMPLEX 3RD FL.334 AMMAN JO","customerAddress":"8-3-677\/18, S.K.D.NAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737052200,"product":"CEFIXIME TRIHYDRATE USP COMPACTED (RE-IMPORT)(CFX-2411411 MFG.DT.OCT-24 EXP.DT.SEP-27)(DRUM NO.7\/40)CEFIXIME TRIHYDRATE USP COMPACTED","address":"DHANUKA HOUSE,861-862,JOSHI ROAD","city":"NEW DELHI ,","supplier":"BILIM ILAC SAN VE TIC AS","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"DHANUKA LABORATORIES LTD","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"145.6","totalValueFC":"3675.8","currency":"USD","unitRateINR":"12678.6","date":"17-Jan-2025","totalValueINR":"316965.07","totalValueInUsd":"3675.8","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"7833409","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ISTANBUL","supplierAddress":"KAPTANPASA MAH ZINCIRLIKUYU CAD NO. 184 BEYOGLU ISTANBUL TURKIYE TURKEY","customerAddress":"DHANUKA HOUSE,861-862,JOSHI ROAD"}]
01-Jan-2022
30-Aug-2025
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

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API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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Europe

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01

OPRD
Not Confirmed
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OPRD
Not Confirmed

Cefixime

Brand Name : CEFIXIMA AUROBINDO ITALY

Dosage Form : Powder For Oral Suspension

Dosage Strength : 100 mg/5 ml

Packaging : 100 ML 2% - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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02

OPRD
Not Confirmed
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OPRD
Not Confirmed

Cefixime

Brand Name : Cefixa

Dosage Form : Cefixima 400Mg 5 Units' Oral Use

Dosage Strength : 5 cpr riv 400 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

EG SPA

Italy
OPRD
Not Confirmed
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EG SPA

Italy
arrow
OPRD
Not Confirmed

Cefixime

Brand Name : CEFIXIME EG

Dosage Form : Powder For Oral Suspension

Dosage Strength : 100 mg/5 ml

Packaging : 100 ML 2% - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

OPRD
Not Confirmed
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OPRD
Not Confirmed

Cefixime

Brand Name : SUPRACEF

Dosage Form : Dispersible Tablets

Dosage Strength : 400 mg

Packaging : 5 UNITS 400 MG - ORAL USE

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

OPRD
Not Confirmed
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OPRD
Not Confirmed

Cefixime

Brand Name : Cefixoral

Dosage Form : Cefixima 400Mg 5 Units' Oral Use

Dosage Strength : 5 cpr riv 400 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

Merck Sl

U.S.A
OPRD
Not Confirmed
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Merck Sl

U.S.A
arrow
OPRD
Not Confirmed

Cefixime

Brand Name : Denvar

Dosage Form : Capsule

Dosage Strength : 400MG

Packaging :

Approval Date : 1994-06-01

Application Number : 60469

Regulatory Info : Authorized

Registration Country : Spain

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07

Merck Sl

U.S.A
OPRD
Not Confirmed
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Merck Sl

U.S.A
arrow
OPRD
Not Confirmed

Cefixime

Brand Name : Denvar

Dosage Form : Granule For Oral Suspension

Dosage Strength : 100MG

Packaging :

Approval Date : 1993-02-01

Application Number : 59733

Regulatory Info : Authorized

Registration Country : Spain

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08

EG SpA

Country
OPRD
Not Confirmed
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EG SpA

Country
arrow
OPRD
Not Confirmed

Cefixime

Brand Name : Cefixa

Dosage Form : Cefixima 2% 100Ml Oral Use

Dosage Strength : groun os suspe 100 ml 100 mg/5 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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09

BENEDETTI & CO.SpA

Country
OPRD
Not Confirmed
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BENEDETTI & CO.SpA

Country
arrow
OPRD
Not Confirmed

Cefixime

Brand Name : Stadium

Dosage Form : Cefixima 400Mg 5 Units' Oral Use

Dosage Strength : 5 cpr riv 400 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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10

EG SpA

Country
OPRD
Not Confirmed
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EG SpA

Country
arrow
OPRD
Not Confirmed

Cefixime

Brand Name : Cefixa

Dosage Form : Cefixima 400Mg 5 Units' Oral Use

Dosage Strength : 5 cpr dispers 400 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Canada

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01

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

CEFIXIME

Brand Name : AURO-CEFIXIME

Dosage Form : TABLET

Dosage Strength : 400MG

Packaging : 7/10/20/500

Approval Date :

Application Number : 2432773

Regulatory Info : Prescription

Registration Country : Canada

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02

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

CEFIXIME

Brand Name : AURO-CEFIXIME

Dosage Form : POWDER FOR SUSPENSION

Dosage Strength : 100MG/5ML

Packaging : 50ML/100ML

Approval Date :

Application Number : 2468689

Regulatory Info : Prescription

Registration Country : Canada

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03

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

CEFIXIME

Brand Name : SUPRAX

Dosage Form : POWDER FOR SUSPENSION

Dosage Strength : 100MG/5ML

Packaging : 50ML

Approval Date :

Application Number : 868965

Regulatory Info : Prescription

Registration Country : Canada

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04

PackExpo
Not Confirmed
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PackExpo
Not Confirmed

CEFIXIME

Brand Name : SUPRAX

Dosage Form : TABLET

Dosage Strength : 400MG

Packaging : 07-Oct

Approval Date :

Application Number : 868981

Regulatory Info : Prescription

Registration Country : Canada

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South Africa

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01

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

Cefixime

Brand Name : Exsef

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

Cefixime

Brand Name : Exsef

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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03

Merck (Pty) Ltd

Germany
Luxepack
Not Confirmed
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Merck (Pty) Ltd

Germany
arrow
Luxepack
Not Confirmed

Cefixime

Brand Name : Fixime 400 Mg

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Merck (Pty) Ltd

Germany
Luxepack
Not Confirmed
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Merck (Pty) Ltd

Germany
arrow
Luxepack
Not Confirmed

Cefixime

Brand Name : Fixime 400 Mg

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Merck (Pty) Ltd

Germany
Luxepack
Not Confirmed
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Merck (Pty) Ltd

Germany
arrow
Luxepack
Not Confirmed

Cefixime

Brand Name : Fixime 400 Mg

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Listed Dossiers

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01

PREP
Not Confirmed
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PREP
Not Confirmed

Cefixime

Brand Name : Cefixime

Dosage Form : Tablet

Dosage Strength : 400MG

Packaging : 2x6, 1x10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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01

PREP
Not Confirmed
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PREP
Not Confirmed

Cefixime

Dosage : Tablet

Dosage Strength : 400MG

Brand Name : Cefixime

Approval Date :

Application Number :

Registration Country : India

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02

PREP
Not Confirmed
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PREP
Not Confirmed

Cefixime; Ofloxacin

Brand Name : Cefixime;Ofloxacin

Dosage Form : Tablet

Dosage Strength : 200MG; 200MG

Packaging : 10x10

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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02

PREP
Not Confirmed
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PREP
Not Confirmed

Cefixime; Ofloxacin

Dosage : Tablet

Dosage Strength : 200MG; 200MG

Brand Name : Cefixime;Ofloxacin

Approval Date :

Application Number :

Registration Country : India

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03

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

Cefixime

Brand Name :

Dosage Form : Tablet

Dosage Strength : 400MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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03

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

Cefixime

Dosage : Tablet

Dosage Strength : 400MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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04

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

Cefixime

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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04

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

Cefixime

Dosage : Film Coated Tablet

Dosage Strength : 200mg

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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05

PREP
Not Confirmed
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PREP
Not Confirmed

Cefixime

Brand Name :

Dosage Form : Oral Suspension

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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05

PREP
Not Confirmed
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PREP
Not Confirmed

Cefixime

Dosage : Oral Suspension

Dosage Strength : 100mg

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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06

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

Cefixime; Clavulanic Acid

Brand Name : Cefixime ; Potassium C...

Dosage Form : Tablet

Dosage Strength : 200 MG ; 125 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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06

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

Cefixime; Clavulanic Acid

Dosage : Tablet

Dosage Strength : 200 MG ; 125 MG

Brand Name : Cefixime ; Potassium C...

Approval Date :

Application Number :

Registration Country : India

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07

PREP
Not Confirmed
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PREP
Not Confirmed

Cefixime

Brand Name : Milfixime-100

Dosage Form : Tablet

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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07

PREP
Not Confirmed
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PREP
Not Confirmed

Cefixime

Dosage : Tablet

Dosage Strength : 100MG

Brand Name : Milfixime-100

Approval Date :

Application Number :

Registration Country : India

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08

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

Cefixime

Brand Name : THEOFIX-100 DT

Dosage Form : Tablet

Dosage Strength : 100MG

Packaging : 2x10 Alu-Alu

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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08

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

Cefixime

Dosage : Tablet

Dosage Strength : 100MG

Brand Name : THEOFIX-100 DT

Approval Date :

Application Number :

Registration Country : India

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09

Luxepack
Not Confirmed
arrow
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Luxepack
Not Confirmed

Cefixime

Brand Name : THEOFIX-200

Dosage Form : Tablet

Dosage Strength : 200MG

Packaging : 2x10 Alu-Alu & 10 x 10 Alu-Alu

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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09

Luxepack
Not Confirmed
arrow
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Luxepack
Not Confirmed

Cefixime

Dosage : Tablet

Dosage Strength : 200MG

Brand Name : THEOFIX-200

Approval Date :

Application Number :

Registration Country : India

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10

Country
PREP
Not Confirmed
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Country
arrow
PREP
Not Confirmed

Cefixime; Clavulanate Potassium

Brand Name : CefiClav 325\n

Dosage Form : Tablet

Dosage Strength : 200MG; 125MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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10

Country
PREP
Not Confirmed
arrow

Country
arrow
PREP
Not Confirmed

Cefixime; Clavulanate Potassium

Dosage : Tablet

Dosage Strength : 200MG; 125MG

Brand Name : CefiClav 325\n

Approval Date :

Application Number :

Registration Country : India

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - FOR SUSPENSION;ORAL - 500MG/5ML

USFDA APPLICATION NUMBER - 202091

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DOSAGE - CAPSULE;ORAL - 400MG

USFDA APPLICATION NUMBER - 203195

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ABOUT THIS PAGE

Looking for 97164-56-2 / Cefixime API manufacturers, exporters & distributors?

Cefixime manufacturers, exporters & distributors 1

61

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.

API | Excipient name

Cefixime

Synonyms

97164-56-2, 79350-37-1, Cefixime(e)-form, (e)-cefixime, Cefixime anhydrous, (e)-, U7rwt9j78o

Cas Number

97164-56-2

Unique Ingredient Identifier (UNII)

U7RWT9J78O

About Cefixime

A third-generation cephalosporin antibiotic that is stable to hydrolysis by beta-lactamases.

Cefixime Anhydrous Manufacturers

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

Cefixime Anhydrous Suppliers

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

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

Cefixime Anhydrous USDMF

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

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

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Cefixime Anhydrous 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 Cefixime Anhydrous Drug Master File in Japan (Cefixime Anhydrous JDMF) empowers Cefixime Anhydrous 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 Cefixime Anhydrous JDMF during the approval evaluation for pharmaceutical products. At the time of Cefixime Anhydrous JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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Cefixime Anhydrous KDMF

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

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

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

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Cefixime Anhydrous CEP

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

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

Cefixime Anhydrous WC

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

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Cefixime Anhydrous 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 Cefixime Anhydrous as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cefixime Anhydrous 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 Cefixime Anhydrous 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 Cefixime Anhydrous and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefixime Anhydrous NDC to their finished compounded human drug products, they may choose to do so.

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

Cefixime Anhydrous GMP

Cefixime Anhydrous 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 Cefixime Anhydrous 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 Cefixime Anhydrous GMP manufacturer or Cefixime Anhydrous GMP API supplier for your needs.

Cefixime Anhydrous CoA

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

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

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