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1. 6-perdeoxy-6-per(2-carboxyethyl)thio-gamma-cyclodextrin Sodium Salt
2. Bridion
3. Org 25969
4. Sugammadex
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
Molecular Weight | 2178.0 g/mol |
---|---|
Molecular Formula | C72H104Na8O48S8 |
Hydrogen Bond Donor Count | 16 |
Hydrogen Bond Acceptor Count | 56 |
Rotatable Bond Count | 32 |
Exact Mass | 2176.2644287 g/mol |
Monoisotopic Mass | 2176.2644287 g/mol |
Topological Polar Surface Area | 995 Ų |
Heavy Atom Count | 136 |
Formal Charge | 0 |
Complexity | 2790 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 40 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 9 |
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.
V03AB35
V03AB35
V03AB35
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
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Rev. Date : 2019-04-23
Pay. Date : 2019-03-28
DMF Number : 32614
Submission : 2018-06-27
Status : Active
Type : II
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DMF Number : 37455
Submission : 2022-09-16
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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Rev. Date : 2019-11-29
Pay. Date : 2019-10-03
DMF Number : 34170
Submission : 2019-10-03
Status : Active
Type : II
GDUFA
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Rev. Date :
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DMF Number : 33747
Submission : 2019-07-24
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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DMF Number : 33924
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Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
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Rev. Date : 2019-08-01
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DMF Number : 33864
Submission : 2019-07-18
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Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
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DMF Number : 34113
Submission : 2019-10-01
Status : Active
Type : II
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DMF Number : 40158
Submission : 2024-07-24
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Type : II
GDUFA
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Rev. Date :
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DMF Number : 33790
Submission : 2019-04-26
Status : Active
Type : II
GDUFA
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Rev. Date : 2019-07-16
Pay. Date : 2019-05-24
DMF Number : 33723
Submission : 2019-03-29
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registration Number : 305MF10068
Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA
Initial Date of Registration : 2023-05-31
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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
NDC Package Code : 60870-0464
Start Marketing Date : 2015-04-01
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NDC Package Code : 58032-2031
Start Marketing Date : 2019-11-13
End Marketing Date : 2025-12-31
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Marketing Category : BULK INGREDIENT
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
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
NDC Package Code : 48087-0152
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NDC Package Code : 53296-0119
Start Marketing Date : 2017-11-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 16436-0119
Start Marketing Date : 2017-11-27
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NDC Package Code : 69766-065
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NDC Package Code : 82393-301
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NDC Package Code : 65129-1418
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End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer of Finished Formulat...
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 100MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 100MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sugammadex Reddy
Dosage Form : Injectable Solution
Dosage Strength : 100mg/ml
Packaging :
Approval Date : 02/06/2022
Application Number : 20211119000032
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Sugammadex Aspen
Dosage Form : Injectable Solution
Dosage Strength : 100MG
Packaging :
Approval Date : 2023-03-15
Application Number : 88555
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sugammadex Aspen
Dosage Form : Injectable Solution
Dosage Strength : 100mg/ml
Packaging :
Approval Date : 13/04/2023
Application Number : 20220404000015
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Versudex
Dosage Form : INJ
Dosage Strength : 100 mg/ml
Packaging : 2X10 mg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sugammadex Orion
Dosage Form : Injectable Solution
Dosage Strength : 100mg/ml
Packaging :
Approval Date : 20/04/2023
Application Number : 20211025000034
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Sugammadex Orion
Dosage Form : Injectable Solution
Dosage Strength : 100MG
Packaging :
Approval Date : 2023-03-28
Application Number : 88751
Regulatory Info : Authorized
Registration Country : Spain
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Availability: Q3 2025
Registration Country : Poland
Brand Name :
Dosage Form : Solution for Injection
Dosage Strength : 100MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q3 2025
Registration Country : Poland
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name : Sugammadex
Dosage Form : Injection
Dosage Strength : 200MG/2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sugammadex Reddy
Dosage Form : Injectable Solution
Dosage Strength : 100mg/ml
Packaging :
Approval Date : 02/06/2022
Application Number : 20211119000032
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Sugammadex Aspen
Dosage Form : Injectable Solution
Dosage Strength : 100MG
Packaging :
Approval Date : 2023-03-15
Application Number : 88555
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sugammadex Aspen
Dosage Form : Injectable Solution
Dosage Strength : 100mg/ml
Packaging :
Approval Date : 13/04/2023
Application Number : 20220404000015
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sugammadex Orion
Dosage Form : Injectable Solution
Dosage Strength : 100mg/ml
Packaging :
Approval Date : 20/04/2023
Application Number : 20211025000034
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Sugammadex Orion
Dosage Form : Injectable Solution
Dosage Strength : 100MG
Packaging :
Approval Date : 2023-03-28
Application Number : 88751
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Sugammadex Accord
Dosage Form : Injectable Solution
Dosage Strength : 100mg/ml
Packaging :
Approval Date : 06/12/2024
Application Number : 20230131000103
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Sugammadex Fresenius Kabi
Dosage Form : Injectable Solution
Dosage Strength : 100MG
Packaging :
Approval Date : 2022-10-06
Application Number : 1221663001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Sugammadex Qilu
Dosage Form : Injectable Solution
Dosage Strength : 100MG
Packaging :
Approval Date : 2022-12-22
Application Number : 88425
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Sugammadex Spirig HC (ml)
Dosage Form : Solution For Injection
Dosage Strength : 200mg/2ml
Packaging :
Approval Date : 07/11/2024
Application Number : 69408
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Suspensed
Registration Country : Spain
Brand Name : Sugammadex Tamarang
Dosage Form : Injectable Solution
Dosage Strength : 100MG
Packaging :
Approval Date : 2022-04-04
Application Number : 86798
Regulatory Info : Suspensed
Registration Country : Spain
Regulatory Info : Prescription
Registration Country : Canada
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
Regulatory Info : Prescription
Registration Country : Canada
SUGAMMADEX (SUGAMMADEX SODIUM)
Brand Name : PMS-SUGAMMADEX
Dosage Form : SOLUTION
Dosage Strength : 100MG/ML
Packaging :
Approval Date :
Application Number : 2550067
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
SUGAMMADEX (SUGAMMADEX SODIUM)
Brand Name : SUGAMMADEX INJECTION
Dosage Form : SOLUTION
Dosage Strength : 100MG/ML
Packaging :
Approval Date :
Application Number : 2548666
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
SUGAMMADEX (SUGAMMADEX SODIUM)
Brand Name : SUGAMMADEX INJECTION
Dosage Form : SOLUTION
Dosage Strength : 100MG/ML
Packaging :
Approval Date :
Application Number : 2539144
Regulatory Info : Prescription
Registration Country : Canada
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DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Dosage Form : Injectable / Parenteral
Grade : Parenteral
Brand Name : Hydrochloric Acid NF
Application : Parenteral
Excipient Details : A&C's Hydrochloric Acid NF is used as a low pH neutralizing agent for pharmaceutical applications.
Global Sales Information
Dosage Form : Sugammadex 200Mg 2Ml 10 Units Pa...
Dosage Strength : 10 VIALS EV 2 ml 100 mg/ml
Price Per Pack (Euro) : 1,221.31
Published in :
Country : Italy
RX/OTC/DISCN : Class H
Dosage Form : Sugammadex 500Mg 5Ml 10 Units Pa...
Dosage Strength : 10 VIALS EV 5 ml 100 mg/ml
Price Per Pack (Euro) : 3,053.24
Published in :
Country : Italy
RX/OTC/DISCN : Class H
Market Place
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2026-01-27
US Patent Number : RE44733
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 22225
Patent Use Code : U-1794
Delist Requested :
Patent Use Description : REVERSAL OF DRUG-INDUC...
Patent Expiration Date : 2026-01-27
Patent Expiration Date : 2026-07-27
US Patent Number : RE44733*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 22225
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-07-27
Patent Expiration Date : 2026-07-27
US Patent Number : RE44733*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 22225
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-07-27
Patent Expiration Date : 2026-01-27
US Patent Number : RE44733
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 22225
Patent Use Code : U-1794
Delist Requested :
Patent Use Description : REVERSAL OF DRUG-INDUC...
Patent Expiration Date : 2026-01-27
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
64
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.
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.
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.
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.
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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.
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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).
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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.
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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).
The FDA updates the NDC directory daily. The NDC numbers for Sugammadex API and other APIs are published in this directory by the FDA.
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.
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.
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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.
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).