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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


API Reference Price

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KGAA","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"12500","totalValueFC":"7271.7","currency":"EUR","unitRateINR":"1157176.7","date":"08-Aug-2022","totalValueINR":"578588.35","totalValueInUsd":"7271.7","indian_port":"DELHI AIR","hs_no":"29329990","bill_no":"9920504","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B-310, SOM DATT CHAMBERS, 1,,BHIKA JI CAMA PLACE,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1668623400,"product":"SUGAMMADEX SODIUM:-FOR EXAMINATION,TEST AND ANALYSIS PURPOSEONLY","address":"COMMERCE HOUSE V BESIDES VODAFONE HOUSE PRAHLADNAGAR CORPORATE RD Con","city":"AHMEDABAD GUJARAT INDIA","supplier":"TAPI TECHNOLOGY & API SERVICES","supplierCountry":"CROATIA","foreign_port":"NA","customer":"ACULIFE HEALTHCARE","customerCountry":"INDIA","quantity":"2.50","actualQuantity":"2.5","unit":"KGS","unitRateFc":"16000","totalValueFC":"41072.1","currency":"USD","unitRateINR":"1340800","date":"17-Nov-2022","totalValueINR":"3352000","totalValueInUsd":"41072.1","indian_port":"AHMEDABAD AIR","hs_no":"29329990","bill_no":"3343483","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"COMMERCE HOUSE V BESIDES VODAFONE HOUSE PRAHLADNAGAR CORPORATE RD Con"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1679423400,"product":"SUGAMMADEX SODIUM (AS PER TEST LIC.NO.TL\/BDZ\/23\/000067 DT:09\/03\/2023)","address":"S.C.O.857, CABIN NO. 10, 2ND FLOOR ,,NAC, MANIMAJRA,","city":"CHANDIGARH,CHANDIGARH","supplier":"FARMHISPANIA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"VENUS REMEDIES","customerCountry":"INDIA","quantity":"0.30","actualQuantity":"300","unit":"GMS","unitRateFc":"25","totalValueFC":"8147.4","currency":"EUR","unitRateINR":"2233.8","date":"22-Mar-2023","totalValueINR":"670125","totalValueInUsd":"8147.4","indian_port":"DELHI AIR","hs_no":"29329990","bill_no":"5170158","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"S.C.O.857, CABIN NO. 10, 2ND FLOOR ,,NAC, MANIMAJRA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714415400,"product":"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","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4000","unit":"GMS","unitRateFc":"18","totalValueFC":"78244.7","currency":"EUR","unitRateINR":"1633.5","date":"30-Apr-2024","totalValueINR":"6534000","totalValueInUsd":"78244.7","indian_port":"Delhi Air","hs_no":"29329990","bill_no":"3273260","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"P.O BOX 452820 DUBAI SCIENCE PARK DUBAI UAE EMIRATES Dubai, , UNITED ARAB EMIRATES UNITED ARAB EMIRATES","customerAddress":"S.C.O.857, CABIN NO. 10, 2ND FLOOR,"},{"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","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":1724610600,"product":"SUGAMMADEX SODIUM","address":"HETERO HOUSE,","city":"HYDERABAD, AP.","supplier":"HONOUR LAB LTD","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"ASPIRO PHARMA","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":"2025","qtr":"Q1","strtotime":1740335400,"product":"SUGAMMADEX SODIUM (LIC. NO: SW\/ND\/CT-17\/2024\/00000396) SUGAMMADEX SODIUM","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"REGEN BIOPHARMA","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.30","actualQuantity":"300","unit":"GMS","unitRateFc":"8.5","totalValueFC":"2573","currency":"USD","unitRateINR":"745.9","date":"24-Feb-2025","totalValueINR":"223762.5","totalValueInUsd":"2573","indian_port":"Ahmedabad Air","hs_no":"29339990","bill_no":"8539912","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"Building C25-28, No.218 Xinghu Road , Suzhou Industrial Park, Suzhou, J iangsu, 215123 China JIANGSU, , Chi China","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741890600,"product":"SUGAMMADEX SODIUM SUGAMMADEX SODIUM","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"M\/S.CHEMISTRY & HEALTH FZ-LLC","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"CAPLIN STERILES LIMITED","customerCountry":"INDIA","quantity":"6.50","actualQuantity":"6500","unit":"GMS","unitRateFc":"5","totalValueFC":"32943.7","currency":"USD","unitRateINR":"439","date":"14-Mar-2025","totalValueINR":"2853500","totalValueInUsd":"32943.7","indian_port":"Madras Air","hs_no":"29329990","bill_no":"8884719","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"PO BOX 452820 DUBAI SCIENCE PARK DUBAI AE","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"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","customerCountry":"INDIA","quantity":"2.10","actualQuantity":"2100","unit":"GMS","unitRateFc":"18","totalValueFC":"38097.8","currency":"EUR","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,"}]
09-Feb-2021
27-Mar-2025
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Drugs in Development

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Details:

Sugammadex is a generic version of bridion which is indicated for reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.


Lead Product(s): Sugammadex Sodium

Therapeutic Area: Neurology Brand Name: Sugammadex Intravenous Solution

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 15, 2024

Towa Pharmaceutical

01

Lead Product(s) : Sugammadex Sodium

Therapeutic Area : Neurology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Inapplicable

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Sugammadex is a generic version of bridion which is indicated for reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.

Product Name : Sugammadex Intravenous Solution

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 15, 2024

Towa Pharmaceutical

Details:

Sugammadex injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL is generic bioequivalent and therapeutically equivalent to Bridion injection of Merck used to reverse the effects of the muscle relaxants rocuronium bromide and vecuronium bromide given to patients during surgery.


Lead Product(s): Sugammadex Sodium

Therapeutic Area: Musculoskeletal Brand Name: Undisclosed

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 10, 2021

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02

Iran Expo
Not Confirmed
Iran Expo
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Details : Sugammadex injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL is generic bioequivalent and therapeutically equivalent to Bridion injection of Merck used to reverse the effects of the muscle relaxants rocuronium bromide and vecuronium bromide given to pat...

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

August 10, 2021

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Europe

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sugammadex

Brand Name : Bridion

Dosage Form : SOLUTION FOR INJECTION

Dosage Strength : 100 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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Sugammadex

Brand Name : Bridion

Dosage Form : Sugammadex 200Mg 2Ml 10 Units Parenteral Use

Dosage Strength : 10 VIALS EV 2 ml 100 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Sugammadex

Brand Name : Bridion

Dosage Form : Sugammadex 500Mg 5Ml 10 Units Parenteral Use

Dosage Strength : 10 VIALS EV 5 ml 100 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Canada

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SUGAMMADEX (SUGAMMADEX SODIUM)

Brand Name : BRIDION

Dosage Form : SOLUTION

Dosage Strength : 100MG/ML

Packaging : 10X2ML/ 10X5ML

Approval Date :

Application Number : 2451816

Regulatory Info : Prescription

Registration Country : Canada

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DRUG PRODUCT COMPOSITIONS

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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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DATA COMPILATION #PharmaFlow

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NEWS #PharmaBuzz

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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.

Sugammadex Manufacturers

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

Sugammadex Suppliers

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

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

Sugammadex USDMF

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

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

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

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

Sugammadex KDMF

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

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

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

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

Sugammadex WC

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

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

Sugammadex 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 Sugammadex as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Sugammadex GMP

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

Sugammadex CoA

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

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

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