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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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CFXU21008)","address":"PLOT NO 53 EPIP PHASE 1 JHARMAJRI,","city":"BADDI,HIMACHAL PRADESH","supplier":"DRUG MANUFACTURING CO LLC","supplierCountry":"OMAN","foreign_port":"#N\/A","customer":"RADDISON PHARMACEUTICALS","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"122","totalValueFC":"6174.2","currency":"USD","unitRateINR":"9198.8","date":"19-Jan-2022","totalValueINR":"459940","totalValueInUsd":"6174.2","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"7148492","productDescription":"API","marketType":"","country":"OMAN","selfForZScoreResived":"Pharma Grade","supplierPort":"#N\/A","supplierAddress":"","customerAddress":"PLOT NO 53 EPIP PHASE 1 JHARMAJRI,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1646677800,"product":"CEFIXIME TRIHYDRATE USP (BATCH NO. CFXU22004)","address":"PLOT NO 53 EPIP PHASE 1 JHARMAJRI,","city":"BADDI,HIMACHAL PRADESH","supplier":"DRUG MANUFACTURING CO LLC","supplierCountry":"OMAN","foreign_port":"NA","customer":"RADDISON PHARMACEUTICALS","customerCountry":"INDIA","quantity":"152.00","actualQuantity":"152","unit":"KGS","unitRateFc":"130","totalValueFC":"19871.6","currency":"USD","unitRateINR":"9964.5","date":"08-Mar-2022","totalValueINR":"1514604","totalValueInUsd":"19871.6","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"7783486","productDescription":"API","marketType":"","country":"OMAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO 53 EPIP PHASE 1 JHARMAJRI,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1646677800,"product":"CEFIXIME TRIHYDRATE USP (BATCH NO. CFXU22005)","address":"PLOT NO 53 EPIP PHASE 1 JHARMAJRI,","city":"BADDI,HIMACHAL PRADESH","supplier":"DRUG MANUFACTURING CO LLC","supplierCountry":"OMAN","foreign_port":"NA","customer":"RADDISON PHARMACEUTICALS","customerCountry":"INDIA","quantity":"47.00","actualQuantity":"47","unit":"KGS","unitRateFc":"130","totalValueFC":"6144.5","currency":"USD","unitRateINR":"9964.5","date":"08-Mar-2022","totalValueINR":"468331.5","totalValueInUsd":"6144.5","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"7783486","productDescription":"API","marketType":"","country":"OMAN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO 53 EPIP PHASE 1 JHARMAJRI,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678818600,"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":"NA","customer":"NECTAR LIFESCIENCES LTD","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"150","totalValueFC":"31659.1","currency":"USD","unitRateINR":"13019.9","date":"15-Mar-2023","totalValueINR":"2603976.41","totalValueInUsd":"31659.1","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"5059844","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"VILLAGE SAIDPURA,TEHSIL DERABASSI"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692297000,"product":"CEFIXIME EP POWDER B.NO.CFX-2305094&5097, MANUFACTURING .APR-23,EXP. 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DT-30\/12\/2022)","address":"ORCHID TOWERS, 313, VALLUVARKOTTAM","city":"CHENNAI","supplier":"TABUK PHARMACEUTICAL MFGCO","supplierCountry":"SAUDI ARABIA","foreign_port":"JEDDAH","customer":"ORCHID PHARMA LTD","customerCountry":"INDIA","quantity":"249.87","actualQuantity":"249.872","unit":"KGS","unitRateFc":"152","totalValueFC":"38400.7","currency":"USD","unitRateINR":"12790.8","date":"13-Oct-2023","totalValueINR":"3196062.78","totalValueInUsd":"38400.7","indian_port":"Madras Air","hs_no":"29419090","bill_no":"8290615","productDescription":"API","marketType":"","country":"SAUDI ARABIA","selfForZScoreResived":"Micronized","supplierPort":"JEDDAH","supplierAddress":"3844 HIGHWAY 15, UNIT NO. 1,TABUKSDNF SAUDI ARABIA","customerAddress":"ORCHID TOWERS, 313, VALLUVARKOTTAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712255400,"product":"CEFIXIME (RE-IMPORT VIDE SB NO:6689479 DT:11.01.2024)","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":"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":"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":"2024","qtr":"Q4","strtotime":1732905000,"product":"CEFIXIME(RE-IMPORT VIDE SB NO:2291913 DT:09.07.2024)","address":"8-3-677\/18, S.K.D.NAGAR","city":"HYDERABAD.AP","supplier":"OMAN PHARMACEUTICAL 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SEEB,SULTANATE OF OMAN","customerAddress":"8-3-677\/18, S.K.D.NAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732905000,"product":"CEFIXIME(RE-IMPORT VIDE SB NO:3654755 DT:31.08.2024)","address":"8-3-677\/18, S.K.D.NAGAR","city":"HYDERABAD.AP","supplier":"OMAN PHARMACEUTICAL PRODUCTS","supplierCountry":"INDIA","foreign_port":"N\/A","customer":"COVALENT LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"199.47","actualQuantity":"199.47","unit":"KGS","unitRateFc":"205","totalValueFC":"41357.4","currency":"USD","unitRateINR":"17496.8","date":"30-Nov-2024","totalValueINR":"3490076.72","totalValueInUsd":"41357.4","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"6968731","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"CO.,L.L.C P.O.BOX:1885,SEEB.POSTAL CODE 111. SEEB,SULTANATE OF OMAN","customerAddress":"8-3-677\/18, S.K.D.NAGAR"}]
01-Jan-2022
31-May-2025
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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

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PharmaCompass offers a list of Cefixime API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cefixime manufacturer or Cefixime supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefixime manufacturer or Cefixime supplier.

PharmaCompass also assists you with knowing the Cefixime API Price utilized in the formulation of products. Cefixime API Price is not always fixed or binding as the Cefixime Price is obtained through a variety of data sources. The Cefixime Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

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.

027, FK Manufacturers

A 027, FK manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 027, FK, including repackagers and relabelers. The FDA regulates 027, FK manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 027, FK 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 027, FK manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

027, FK Suppliers

A 027, FK supplier is an individual or a company that provides 027, FK active pharmaceutical ingredient (API) or 027, FK finished formulations upon request. The 027, FK suppliers may include 027, FK API manufacturers, exporters, distributors and traders.

click here to find a list of 027, FK suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

027, FK USDMF

A 027, FK DMF (Drug Master File) is a document detailing the whole manufacturing process of 027, FK active pharmaceutical ingredient (API) in detail. Different forms of 027, FK DMFs exist exist since differing nations have different regulations, such as 027, FK USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 027, FK DMF submitted to regulatory agencies in the US is known as a USDMF. 027, FK USDMF includes data on 027, FK's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 027, FK USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 027, FK suppliers with USDMF on PharmaCompass.

027, FK 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 027, FK Drug Master File in Japan (027, FK JDMF) empowers 027, FK 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 027, FK JDMF during the approval evaluation for pharmaceutical products. At the time of 027, FK 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 027, FK suppliers with JDMF on PharmaCompass.

027, FK KDMF

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

Pharmaceutical companies submit a 027, FK Drug Master File in Korea (027, FK KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 027, FK. The MFDS reviews the 027, FK KDMF as part of the drug registration process and uses the information provided in the 027, FK KDMF to evaluate the safety and efficacy of the drug.

After submitting a 027, FK 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 027, FK API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 027, FK suppliers with KDMF on PharmaCompass.

027, FK CEP

A 027, FK CEP of the European Pharmacopoeia monograph is often referred to as a 027, FK Certificate of Suitability (COS). The purpose of a 027, FK CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 027, FK EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 027, FK to their clients by showing that a 027, FK CEP has been issued for it. The manufacturer submits a 027, FK CEP (COS) as part of the market authorization procedure, and it takes on the role of a 027, FK CEP holder for the record. Additionally, the data presented in the 027, FK CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 027, FK DMF.

A 027, FK CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 027, FK 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 027, FK suppliers with CEP (COS) on PharmaCompass.

027, FK WC

A 027, FK written confirmation (027, FK WC) is an official document issued by a regulatory agency to a 027, FK manufacturer, verifying that the manufacturing facility of a 027, FK active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 027, FK APIs or 027, FK finished pharmaceutical products to another nation, regulatory agencies frequently require a 027, FK WC (written confirmation) as part of the regulatory process.

click here to find a list of 027, FK suppliers with Written Confirmation (WC) on PharmaCompass.

027, FK 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 027, FK as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 027, FK 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 027, FK 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 027, FK and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 027, FK NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 027, FK suppliers with NDC on PharmaCompass.

027, FK GMP

027, FK 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 027, FK 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 027, FK GMP manufacturer or 027, FK GMP API supplier for your needs.

027, FK CoA

A 027, FK CoA (Certificate of Analysis) is a formal document that attests to 027, FK's compliance with 027, FK specifications and serves as a tool for batch-level quality control.

027, FK CoA mostly includes findings from lab analyses of a specific batch. For each 027, FK 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.

027, FK may be tested according to a variety of international standards, such as European Pharmacopoeia (027, FK EP), 027, FK JP (Japanese Pharmacopeia) and the US Pharmacopoeia (027, FK 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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