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1. Valbenazine Ditosylate
2. 1639208-54-0
3. Valbenazine Tosilate
4. Valbenazine (tosylate)
5. Nbi-98854 Ditosylate
6. Valbenazine Tosylate [usan]
7. 5sml1t733b
8. 1639208-54-0 (tosylayte)
9. Valbenazine Tosilate (jan)
10. Valbenazine Tosylate (usan)
11. Valbenazine Tosilate [jan]
12. (2r,3r,11br)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2h-pyrido[2,1-a]isoquinolin-2-yl L-valinate Di(4-methylbenzenesulfonate)
13. L-valine, (2r,3r,11br)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2h-benzo(a)quinolizin-2-yl Ester, 4-methylbenzenesulfonate (1:2)
14. Ingrezza (tn)
15. Nbi-98854 Tosylate
16. Unii-5sml1t733b
17. Valbenazine Tosylate (1:2)
18. Chembl3707248
19. Schembl18863051
20. Valbenazine Tosylate [mi]
21. Dtxsid201026308
22. Hy-16771a
23. S9500
24. Valbenazine Tosilate [who-dd]
25. Ccg-270445
26. Valbenazine Tosylate [orange Book]
27. Cs-0030913
28. D10999
29. Q27262815
30. (2r,3r,11br)-9,10-dimethoxy-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2h-benzo(a)quinolizin-2-yl L-valinate Bis(4-methylbenzenesulfonate)
31. [(2r,3r,11br)-9,10-dimethoxy-3-(2-methylpropyl)-2,3,4,6,7,11b-hexahydro-1h-benzo[a]quinolizin-2-yl] (2s)-2-amino-3-methylbutanoate;4-methylbenzenesulfonic Acid
Molecular Weight | 763.0 g/mol |
---|---|
Molecular Formula | C38H54N2O10S2 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 12 |
Rotatable Bond Count | 10 |
Exact Mass | 762.32198827 g/mol |
Monoisotopic Mass | 762.32198827 g/mol |
Topological Polar Surface Area | 200 Ų |
Heavy Atom Count | 52 |
Formal Charge | 0 |
Complexity | 776 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 4 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-25
Pay. Date : 2021-01-11
DMF Number : 35195
Submission : 2020-12-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-30
Pay. Date : 2020-10-22
DMF Number : 35246
Submission : 2020-10-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34720
Submission : 2020-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-02
Pay. Date : 2020-10-09
DMF Number : 35290
Submission : 2020-10-28
Status : Active
Type : II
Date of Issue : 2022-07-15
Valid Till : 2025-07-15
Written Confirmation Number : WC-0200n
Address of the Firm : W-41 & 42, MIDC Indl. Estate, Morivali Village, Ambernath (W), Dist. Thane, Maha...
Registrant Name : Mitsubishi Tanabe Pharma Korea Co., Ltd.
Registration Date : 2021-11-30
Registration Number : Su40-1-ND
Manufacturer Name : Mitsubishi Tanabe Pharma Kor...
Manufacturer Address : 80, Pharmaceutical Complex 2-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do @Sete Casas,...
NDC Package Code : 48087-0139
Start Marketing Date : 2018-12-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 48087-0166
Start Marketing Date : 2023-09-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69766-084
Start Marketing Date : 2020-03-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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PharmaCompass offers a list of Valbenazine Tosylate 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 Valbenazine Tosylate manufacturer or Valbenazine Tosylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Valbenazine Tosylate manufacturer or Valbenazine Tosylate supplier.
PharmaCompass also assists you with knowing the Valbenazine Tosylate API Price utilized in the formulation of products. Valbenazine Tosylate API Price is not always fixed or binding as the Valbenazine Tosylate Price is obtained through a variety of data sources. The Valbenazine Tosylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Valbenazine Ditosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valbenazine Ditosylate, including repackagers and relabelers. The FDA regulates Valbenazine Ditosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valbenazine Ditosylate 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 Valbenazine Ditosylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valbenazine Ditosylate supplier is an individual or a company that provides Valbenazine Ditosylate active pharmaceutical ingredient (API) or Valbenazine Ditosylate finished formulations upon request. The Valbenazine Ditosylate suppliers may include Valbenazine Ditosylate API manufacturers, exporters, distributors and traders.
click here to find a list of Valbenazine Ditosylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valbenazine Ditosylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Valbenazine Ditosylate active pharmaceutical ingredient (API) in detail. Different forms of Valbenazine Ditosylate DMFs exist exist since differing nations have different regulations, such as Valbenazine Ditosylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valbenazine Ditosylate DMF submitted to regulatory agencies in the US is known as a USDMF. Valbenazine Ditosylate USDMF includes data on Valbenazine Ditosylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valbenazine Ditosylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valbenazine Ditosylate suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Valbenazine Ditosylate Drug Master File in Korea (Valbenazine Ditosylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Valbenazine Ditosylate. The MFDS reviews the Valbenazine Ditosylate KDMF as part of the drug registration process and uses the information provided in the Valbenazine Ditosylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Valbenazine Ditosylate 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 Valbenazine Ditosylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Valbenazine Ditosylate suppliers with KDMF on PharmaCompass.
A Valbenazine Ditosylate written confirmation (Valbenazine Ditosylate WC) is an official document issued by a regulatory agency to a Valbenazine Ditosylate manufacturer, verifying that the manufacturing facility of a Valbenazine Ditosylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Valbenazine Ditosylate APIs or Valbenazine Ditosylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Valbenazine Ditosylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Valbenazine Ditosylate suppliers with Written Confirmation (WC) on PharmaCompass.
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 Valbenazine Ditosylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Valbenazine Ditosylate 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 Valbenazine Ditosylate 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 Valbenazine Ditosylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Valbenazine Ditosylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Valbenazine Ditosylate suppliers with NDC on PharmaCompass.
Valbenazine Ditosylate 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 Valbenazine Ditosylate 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 Valbenazine Ditosylate GMP manufacturer or Valbenazine Ditosylate GMP API supplier for your needs.
A Valbenazine Ditosylate CoA (Certificate of Analysis) is a formal document that attests to Valbenazine Ditosylate's compliance with Valbenazine Ditosylate specifications and serves as a tool for batch-level quality control.
Valbenazine Ditosylate CoA mostly includes findings from lab analyses of a specific batch. For each Valbenazine Ditosylate 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.
Valbenazine Ditosylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Valbenazine Ditosylate EP), Valbenazine Ditosylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Valbenazine Ditosylate USP).