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Chemistry

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Also known as: 343306-79-6, Bridion, Org 25969, Org-25969, Erj6x2mxv7, 343306-71-8
Molecular Formula
C72H104Na8O48S8
Molecular Weight
2178.0  g/mol
InChI Key
KMGKABOMYQLLDJ-VKHHSAQNSA-F
FDA UNII
ERJ6X2MXV7

Sugammadex Sodium
A gamma-cyclodextrin that functions as a reversal agent for the neuromuscular blocker ROCURONIUM BROMIDE.
1 2D Structure

Sugammadex Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
octasodium;3-[[(1S,3S,5S,6S,8S,10S,11S,13S,15S,16S,18S,20S,21S,23S,25S,26S,28S,30S,31S,33S,35S,36S,38S,40S,41R,42R,43R,44R,45R,46R,47R,48R,49R,50R,51R,52R,53R,54R,55R,56R)-10,15,20,25,30,35,40-heptakis(2-carboxylatoethylsulfanylmethyl)-41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56-hexadecahydroxy-2,4,7,9,12,14,17,19,22,24,27,29,32,34,37,39-hexadecaoxanonacyclo[36.2.2.23,6.28,11.213,16.218,21.223,26.228,31.233,36]hexapentacontan-5-yl]methylsulfanyl]propanoate
2.1.2 InChI
InChI=1S/C72H112O48S8.8Na/c73-33(74)1-9-121-17-25-57-41(89)49(97)65(105-25)114-58-26(18-122-10-2-34(75)76)107-67(51(99)43(58)91)116-60-28(20-124-12-4-36(79)80)109-69(53(101)45(60)93)118-62-30(22-126-14-6-38(83)84)111-71(55(103)47(62)95)120-64-32(24-128-16-8-40(87)88)112-72(56(104)48(64)96)119-63-31(23-127-15-7-39(85)86)110-70(54(102)46(63)94)117-61-29(21-125-13-5-37(81)82)108-68(52(100)44(61)92)115-59-27(19-123-11-3-35(77)78)106-66(113-57)50(98)42(59)90;;;;;;;;/h25-32,41-72,89-104H,1-24H2,(H,73,74)(H,75,76)(H,77,78)(H,79,80)(H,81,82)(H,83,84)(H,85,86)(H,87,88);;;;;;;;/q;8*+1/p-8/t25-,26-,27-,28-,29-,30-,31-,32-,41-,42-,43-,44-,45-,46-,47-,48-,49-,50-,51-,52-,53-,54-,55-,56-,57-,58-,59-,60-,61-,62-,63-,64-,65-,66-,67-,68-,69-,70-,71-,72-;;;;;;;;/m1......../s1
2.1.3 InChI Key
KMGKABOMYQLLDJ-VKHHSAQNSA-F
2.1.4 Canonical SMILES
C(CSCC1C2C(C(C(O1)OC3C(OC(C(C3O)O)OC4C(OC(C(C4O)O)OC5C(OC(C(C5O)O)OC6C(OC(C(C6O)O)OC7C(OC(C(C7O)O)OC8C(OC(C(C8O)O)OC9C(OC(O2)C(C9O)O)CSCCC(=O)[O-])CSCCC(=O)[O-])CSCCC(=O)[O-])CSCCC(=O)[O-])CSCCC(=O)[O-])CSCCC(=O)[O-])CSCCC(=O)[O-])O)O)C(=O)[O-].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
2.1.5 Isomeric SMILES
C(CSC[C@@H]1[C@@H]2[C@@H]([C@H]([C@H](O1)O[C@@H]3[C@H](O[C@@H]([C@@H]([C@H]3O)O)O[C@@H]4[C@H](O[C@@H]([C@@H]([C@H]4O)O)O[C@@H]5[C@H](O[C@@H]([C@@H]([C@H]5O)O)O[C@@H]6[C@H](O[C@@H]([C@@H]([C@H]6O)O)O[C@@H]7[C@H](O[C@@H]([C@@H]([C@H]7O)O)O[C@@H]8[C@H](O[C@@H]([C@@H]([C@H]8O)O)O[C@@H]9[C@H](O[C@H](O2)[C@@H]([C@H]9O)O)CSCCC(=O)[O-])CSCCC(=O)[O-])CSCCC(=O)[O-])CSCCC(=O)[O-])CSCCC(=O)[O-])CSCCC(=O)[O-])CSCCC(=O)[O-])O)O)C(=O)[O-].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+].[Na+]
2.2 Other Identifiers
2.2.1 UNII
ERJ6X2MXV7
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 6-perdeoxy-6-per(2-carboxyethyl)thio-gamma-cyclodextrin Sodium Salt

2. Bridion

3. Org 25969

4. Sugammadex

2.3.2 Depositor-Supplied Synonyms

1. 343306-79-6

2. Bridion

3. Org 25969

4. Org-25969

5. Erj6x2mxv7

6. 343306-71-8

7. Sugammadex Octasodium Salt

8. Sugammadex (sodium)

9. Unii-erj6x2mxv7

10. Sugammadex Sodium [usan]

11. Sugammadexsodium

12. Sugammadex Sodium [usan:jan]

13. Bridion (tn)

14. Mk-8616

15. Org25969

16. Sugammadex Sodium (jan/usan)

17. Sugammadex Sodium [jan]

18. Chebi:90952

19. Sugammadex Sodium [mart.]

20. Sugammadex Sodium [who-dd]

21. Amy12422

22. Ex-a2600

23. Sch-900616

24. Sugammadex Octasodium Salt [mi]

25. Sugammadex Sodium [orange Book]

26. Ac-30384

27. C13789

28. D05940

29. .gamma.-cyclodextrin, 6a,6b,6c,6d,6e,7f,6g,6h-octakis-s-(2-carboxyethyl)-6a,6b,6c,6d,6e,7f,6g,6h-octathio-, Octasodium Salt

30. Gamma-cyclodextrin, 6a,6b,6c,6d,6e,7f,6g,6h-octakis-s-(2-carboxyethyl)-6a,6b,6c,6d,6e,7f,6g,6h-octathio-, Octasodium Salt

31. Octasodium 6,6',6'',6''',6'''',6''''',6'''''',6'''''''-octakis-s-(2-carboxylatoethyl)-6,6',6'',6''',6'''',6''''',6'''''',6'''''''-octathiocyclo-alpha-(1-4)-d-octaglucopyranoside

2.4 Create Date
2006-07-28
3 Chemical and Physical Properties
Molecular Weight 2178.0 g/mol
Molecular Formula C72H104Na8O48S8
Hydrogen Bond Donor Count16
Hydrogen Bond Acceptor Count56
Rotatable Bond Count32
Exact Mass2176.2644287 g/mol
Monoisotopic Mass2176.2644287 g/mol
Topological Polar Surface Area995 Ų
Heavy Atom Count136
Formal Charge0
Complexity2790
Isotope Atom Count0
Defined Atom Stereocenter Count40
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count9
4 Drug and Medication Information
4.1 Drug Indication

Reversal of neuromuscular blockade induced by rocuronium or vecuronium.

For the peadiatric population: sugammadex is only recommended for routine reversal of rocuronium-induced blockade in children and adolescents.


Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.

For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.


Reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.

For the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.


5 Pharmacology and Biochemistry
5.1 ATC Code

V03AB35


V03AB35


V03AB35


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SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700418600,"product":"SUGAMMADEX SODIUM","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"BRIGHTGENE BIO-MEDICAL TECHNOLOGY COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"INTAS PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"0.60","actualQuantity":"600","unit":"GMS","unitRateFc":"7.2","totalValueFC":"7714.1","currency":"USD","unitRateINR":"1070.6","date":"20-Nov-2023","totalValueINR":"642355.8","totalValueInUsd":"7714.1","indian_port":"Ahmedabad Air","hs_no":"29339990","bill_no":"8852112","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"Building C25-28, No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, 215123 China JIANGSU, , Chi China","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716489000,"product":"SUGAMMADEX SODIUM","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"BRIGHTGENE BIO MEDICAL","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"JODAS EXPOIM PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.80","actualQuantity":"1.8","unit":"KGS","unitRateFc":"6400","totalValueFC":"11657.6","currency":"USD","unitRateINR":"539840","date":"24-May-2024","totalValueINR":"971712","totalValueInUsd":"11657.6","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"3642123","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"TECHNOLOGY CO LTD BUILDING C25-C28NO.218 XINGHU ROADSDNF China","customerAddress":"101, SITARAM MANSION,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722623400,"product":"SUGAMMADEX SODIUM:-FOR EXAMINATION,TEST AND ANALYSIS PURPOSEONLY","address":"COMMERCE HOUSE V,BESIDES VODAFONE","city":"AHMEDABAD, GUJARAT. INDIA.","supplier":"MEDICHEM MANUFACTURING MALTA LTD","supplierCountry":"MALTA","foreign_port":"MALTA","customer":"ACULIFE HEALTHCARE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.04","actualQuantity":"0.044","unit":"KGS","unitRateFc":"7500","totalValueFC":"332.8","currency":"USD","unitRateINR":"634500","date":"03-Aug-2024","totalValueINR":"27918","totalValueInUsd":"332.8","indian_port":"Ahmedabad Air","hs_no":"29329990","bill_no":"4850282","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"HF 61, HAL FAR INDUSTRIAL ESTATEBBG-3000,HAL FAR, MALTA","customerAddress":"COMMERCE HOUSE V,BESIDES VODAFONE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722623400,"product":"SUGAMMADEX SODIUM:-FOR EXAMINATION,TEST AND ANALYSIS PURPOSEONLY","address":"COMMERCE HOUSE V,BESIDES VODAFONE","city":"AHMEDABAD, GUJARAT. INDIA.","supplier":"MEDICHEM MANUFACTURING MALTA LTD","supplierCountry":"MALTA","foreign_port":"MALTA","customer":"ACULIFE HEALTHCARE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.40","actualQuantity":"0.4","unit":"KGS","unitRateFc":"7500","totalValueFC":"3025.8","currency":"USD","unitRateINR":"634500","date":"03-Aug-2024","totalValueINR":"253800","totalValueInUsd":"3025.8","indian_port":"Ahmedabad Air","hs_no":"29329990","bill_no":"4850282","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"HF 61, HAL FAR INDUSTRIAL ESTATEBBG-3000,HAL FAR, MALTA","customerAddress":"COMMERCE HOUSE V,BESIDES VODAFONE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722623400,"product":"SUGAMMADEX SODIUM:-FOR EXAMINATION,TEST AND ANALYSIS PURPOSEONLY","address":"COMMERCE HOUSE V,BESIDES VODAFONE","city":"AHMEDABAD, GUJARAT. INDIA.","supplier":"MEDICHEM MANUFACTURING MALTA LTD","supplierCountry":"MALTA","foreign_port":"MALTA","customer":"ACULIFE HEALTHCARE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"7500","totalValueFC":"15129","currency":"USD","unitRateINR":"634500","date":"03-Aug-2024","totalValueINR":"1269000","totalValueInUsd":"15129","indian_port":"Ahmedabad Air","hs_no":"29329990","bill_no":"4850282","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"HF 61, HAL FAR INDUSTRIAL ESTATEBBG-3000,HAL FAR, MALTA","customerAddress":"COMMERCE HOUSE V,BESIDES VODAFONE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724610600,"product":"SUGAMMADEX SODIUM","address":"HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB LIMITED","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"ASPIRO PHARMA LIMITED","customerCountry":"INDIA","quantity":"7.94","actualQuantity":"7.94","unit":"KGS","unitRateFc":"5303.5","totalValueFC":"42597.3","currency":"USD","unitRateINR":"450000","date":"26-Aug-2024","totalValueINR":"3573000","totalValueInUsd":"42597.3","indian_port":"Vizag-HIPL SEZ","hs_no":"29329990","bill_no":"5248594","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"HETERO INFRASTRUCTURE SEZ LTD N.NARASAPURAM VILLAGE NAKKAPALLY SDNF India","customerAddress":"HETERO HOUSE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729881000,"product":"SUGAMMADEX SODIUM (100%EOU) (TEST & ANALYSIS)","address":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR","city":"SRIPERUMPUDUR,TAMIL NADU","supplier":"TEVA API BV","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"PFIZER HEALTHCARE INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"15000","totalValueFC":"15164.8","currency":"USD","unitRateINR":"1274250","date":"26-Oct-2024","totalValueINR":"1274250","totalValueInUsd":"15164.8","indian_port":"Madras Air","hs_no":"29329990","bill_no":"6349063","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"PIET HEIN BUILDING, PIET HEINKADE 1 07 1019 GM AMSTERDAM THE NETHERLAND S CHAMBER OF COMMERCE AMSTERDAM 300 NETHERLANDS","customerAddress":"PLOT NO.B3,B4&B5 PT SIPCOT,INDUSTR"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738002600,"product":"SUGAMMADEX SODIUM SUGAMMADEX SODIUM","address":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ","city":"AMRITSAR,PUNJAB","supplier":"SHANDONG CHENGHUISHUANGDA PHARMACEUTICAL CO","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"KWALITY PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"0.60","actualQuantity":"0.6","unit":"KGS","unitRateFc":"3833.3","totalValueFC":"2323.2","currency":"USD","unitRateINR":"333883.1","date":"28-Jan-2025","totalValueINR":"200329.83","totalValueInUsd":"2323.2","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"8058030","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"LTD. THE ECONOMIC DEVELOPMENT ZONE PINGYUAN COUNTY DEZHOU CITY SHAND ONG PROVINCE","customerAddress":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742581800,"product":"SUGAMMADEX SODIUM SUGAMMADEX SODIUM","address":"S.C.O.857, CABIN NO. 10, 2ND FLOOR,","city":"CHANDIGARH.","supplier":"CHEMISTRY & HEALTH FZ LLC","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"VENUS REMEDIES LIMITED","customerCountry":"INDIA","quantity":"2.10","actualQuantity":"2100","unit":"GMS","unitRateFc":"18","totalValueFC":"38097.8","currency":"EURO","unitRateINR":"1571.4","date":"22-Mar-2025","totalValueINR":"3299940","totalValueInUsd":"38097.8","indian_port":"Delhi Air","hs_no":"29329990","bill_no":"9036625","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"P.O BOX 452820 DUBAI SCIENCE PARK D UBAI UAE EMIRATES Dubai, , UNITED A RAB EMIRATES UNITED ARAB EMIRATES","customerAddress":"S.C.O.857, CABIN NO. 10, 2ND FLOOR,"}]
03-Jan-2022
30-Apr-2025
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DOSAGE - SOLUTION;INTRAVENOUS - EQ 200MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

USFDA APPLICATION NUMBER - 22225

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DOSAGE - SOLUTION;INTRAVENOUS - EQ 500MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

USFDA APPLICATION NUMBER - 22225

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ABOUT THIS PAGE

Looking for 343306-79-6 / Sugammadex Sodium API manufacturers, exporters & distributors?

Sugammadex Sodium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Sugammadex Sodium 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 Sugammadex Sodium manufacturer or Sugammadex Sodium supplier for your needs.

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

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

API | Excipient name

Sugammadex Sodium

Synonyms

343306-79-6, Bridion, Org 25969, Org-25969, Erj6x2mxv7, 343306-71-8

Cas Number

343306-79-6

Unique Ingredient Identifier (UNII)

ERJ6X2MXV7

About Sugammadex Sodium

A gamma-cyclodextrin that functions as a reversal agent for the neuromuscular blocker ROCURONIUM BROMIDE.

343306-71-8 Manufacturers

A 343306-71-8 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 343306-71-8, including repackagers and relabelers. The FDA regulates 343306-71-8 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 343306-71-8 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 343306-71-8 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

343306-71-8 Suppliers

A 343306-71-8 supplier is an individual or a company that provides 343306-71-8 active pharmaceutical ingredient (API) or 343306-71-8 finished formulations upon request. The 343306-71-8 suppliers may include 343306-71-8 API manufacturers, exporters, distributors and traders.

click here to find a list of 343306-71-8 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

343306-71-8 USDMF

A 343306-71-8 DMF (Drug Master File) is a document detailing the whole manufacturing process of 343306-71-8 active pharmaceutical ingredient (API) in detail. Different forms of 343306-71-8 DMFs exist exist since differing nations have different regulations, such as 343306-71-8 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 343306-71-8 DMF submitted to regulatory agencies in the US is known as a USDMF. 343306-71-8 USDMF includes data on 343306-71-8's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 343306-71-8 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 343306-71-8 suppliers with USDMF on PharmaCompass.

343306-71-8 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 343306-71-8 Drug Master File in Japan (343306-71-8 JDMF) empowers 343306-71-8 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 343306-71-8 JDMF during the approval evaluation for pharmaceutical products. At the time of 343306-71-8 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 343306-71-8 suppliers with JDMF on PharmaCompass.

343306-71-8 KDMF

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

Pharmaceutical companies submit a 343306-71-8 Drug Master File in Korea (343306-71-8 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 343306-71-8. The MFDS reviews the 343306-71-8 KDMF as part of the drug registration process and uses the information provided in the 343306-71-8 KDMF to evaluate the safety and efficacy of the drug.

After submitting a 343306-71-8 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 343306-71-8 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 343306-71-8 suppliers with KDMF on PharmaCompass.

343306-71-8 WC

A 343306-71-8 written confirmation (343306-71-8 WC) is an official document issued by a regulatory agency to a 343306-71-8 manufacturer, verifying that the manufacturing facility of a 343306-71-8 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 343306-71-8 APIs or 343306-71-8 finished pharmaceutical products to another nation, regulatory agencies frequently require a 343306-71-8 WC (written confirmation) as part of the regulatory process.

click here to find a list of 343306-71-8 suppliers with Written Confirmation (WC) on PharmaCompass.

343306-71-8 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 343306-71-8 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 343306-71-8 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 343306-71-8 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 343306-71-8 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 343306-71-8 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 343306-71-8 suppliers with NDC on PharmaCompass.

343306-71-8 GMP

343306-71-8 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 343306-71-8 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 343306-71-8 GMP manufacturer or 343306-71-8 GMP API supplier for your needs.

343306-71-8 CoA

A 343306-71-8 CoA (Certificate of Analysis) is a formal document that attests to 343306-71-8's compliance with 343306-71-8 specifications and serves as a tool for batch-level quality control.

343306-71-8 CoA mostly includes findings from lab analyses of a specific batch. For each 343306-71-8 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.

343306-71-8 may be tested according to a variety of international standards, such as European Pharmacopoeia (343306-71-8 EP), 343306-71-8 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (343306-71-8 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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