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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 SUPPLIERS

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NDC API

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01

Aspen Oss B.V.

Netherlands
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Virtual BoothAspen API. More than just an API™

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SUGAMMADEX

NDC Package Code : 60870-0464

Start Marketing Date : 2015-04-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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SUGAMMADEX SODIUM

NDC Package Code : 71796-003

Start Marketing Date : 2018-06-27

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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SUGAMMADEX

NDC Package Code : 58032-2031

Start Marketing Date : 2019-11-13

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Neuland

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Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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SUGAMMADEX SODIUM

NDC Package Code : 69037-0050

Start Marketing Date : 2015-12-15

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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SUGAMMADEX

NDC Package Code : 48087-0151

Start Marketing Date : 2020-03-05

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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SUGAMMADEX SODIUM

NDC Package Code : 65129-1418

Start Marketing Date : 2022-01-07

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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SUGAMMADEX SODIUM

NDC Package Code : 83137-0005

Start Marketing Date : 2023-02-01

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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SUGAMMADEX SODIUM

NDC Package Code : 72643-024

Start Marketing Date : 2020-06-10

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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SUGAMMADEX SODIUM

NDC Package Code : 51846-1056

Start Marketing Date : 2017-10-02

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (100kg/100kg)

Marketing Category : BULK INGREDIENT

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SUGAMMADEX SODIUM

NDC Package Code : 62147-0278

Start Marketing Date : 2019-12-20

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (50kg/50kg)

Marketing Category : BULK INGREDIENT

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API Reference Price

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INDIA.","supplier":"MEDICHEM MANUFACTURING MALTA LTD","supplierCountry":"MALTA","foreign_port":"MALTA","customer":"ACULIFE HEALTHCARE PRIVATE LTD","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 LTD","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"ASPIRO PHARMA LTD","customerCountry":"INDIA","quantity":"2.73","actualQuantity":"2.73","unit":"KGS","unitRateFc":"5303.5","totalValueFC":"14646.2","currency":"USD","unitRateINR":"450000","date":"26-Aug-2024","totalValueINR":"1228500","totalValueInUsd":"14646.2","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":"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 LTD","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":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 LTD","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 LTD","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,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747420200,"product":"SUGAMMADEX SODIUM SUGAMMADEX SODIUM","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"BRIGHTGENE BIO MEDICAL TECHNOLOGY CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"JODAS EXPOIM PRIVATE LTD","customerCountry":"INDIA","quantity":"20.50","actualQuantity":"20.5","unit":"KGS","unitRateFc":"5500","totalValueFC":"114337.2","currency":"USD","unitRateINR":"475200","date":"17-May-2025","totalValueINR":"9741600","totalValueInUsd":"114337.2","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"2118386","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"BUILDING C25-C31 NO 218 XINGHU ROAD SDNF SDNF China","customerAddress":"101, SITARAM MANSION,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750357800,"product":"7MPS028 SUGAMMADEX (SUGAMMADEX SODIUM) (F.O.C) 7MPS028 SUGAMMADEX (SUGAMMADEX SODIUM) (F.O.C)","address":"236, OKHLA INDUSTRIAL AREA,PHASE.","city":"NEW DELHI","supplier":"TAPI NL BV","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"MANKIND PHARMA LTD","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"9800","totalValueFC":"99966.9","currency":"USD","unitRateINR":"858970","date":"20-Jun-2025","totalValueINR":"8589700","totalValueInUsd":"99966.9","indian_port":"Delhi Air","hs_no":"29329990","bill_no":"2787922","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"PIET HEINKADE 55 1019 GM AMSTERDAM THE NETHERLANDS NETHERLANDS","customerAddress":"236, OKHLA INDUSTRIAL AREA,PHASE."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1754591400,"product":"SUGAMMADEX SODIUM SUGAMMADEX SODIUM","address":"NARBAVI NO3 LAKSHMANAN STREET,,T.N","city":"CHENNAI,TAMIL NADU","supplier":"CHEMISTRY HEALTH FZ LLC","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"CAPLIN STERILES LTD","customerCountry":"INDIA","quantity":"4.50","actualQuantity":"4500","unit":"GMS","unitRateFc":"5","totalValueFC":"22777.7","currency":"USD","unitRateINR":"443","date":"08-Aug-2025","totalValueINR":"1993500","totalValueInUsd":"22777.7","indian_port":"Madras Air","hs_no":"29329990","bill_no":"3762451","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"P.O. BOX 452820 DUBAI SCIENCE PARK DUBAI SDNF AE","customerAddress":"NARBAVI NO3 LAKSHMANAN STREET,,T.N"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1760121000,"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 LTD","customerCountry":"INDIA","quantity":"2.90","actualQuantity":"2900","unit":"GMS","unitRateFc":"14.2","totalValueFC":"41900","currency":"EURO","unitRateINR":"1276.8","date":"11-Oct-2025","totalValueINR":"3702720","totalValueInUsd":"41900","indian_port":"Delhi Air","hs_no":"29329990","bill_no":"5037951","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
17-Nov-2025
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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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DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions
The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 

Impressions: 2965

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-rise-4-5-in-q3-2025-china-holds-lead-india-records-20-growth-in-submissions

#PharmaFlow by PHARMACOMPASS
13 Nov 2025

NEWS #PharmaBuzz

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214230

FDA
01 Dec 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213868

FDA
06 Nov 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214276

FDA
27 Aug 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214311

FDA
20 May 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213915

FDA
20 Nov 2024

https://www.towayakuhin.co.jp/english/assets/release241205.pdf

PRESS RELEASE
05 Nov 2024

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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 Sodium Manufacturers

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

Sugammadex Sodium Suppliers

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

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

Sugammadex Sodium USDMF

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

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

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

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

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

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

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

Sugammadex Sodium WC

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

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

Sugammadex Sodium 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 Sodium as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Sugammadex Sodium GMP

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

Sugammadex Sodium CoA

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

Sugammadex Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Sugammadex Sodium 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 Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Sugammadex Sodium EP), Sugammadex Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sugammadex Sodium 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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