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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 |
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-01-25
Pay. Date : 2021-01-11
DMF Number : 35195
Submission : 2020-12-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-02
Pay. Date : 2020-10-09
DMF Number : 35290
Submission : 2020-10-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-30
Pay. Date : 2020-10-22
DMF Number : 35246
Submission : 2020-10-13
Status : Active
Type : II
Date of Issue : 2022-07-15
Valid Till : 2025-07-15
Written Confirmation Number : WC-0200n
Address of the Firm :
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
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (N...
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Details:
Valbenazine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Obsessive-Compulsive Disorder.
Lead Product(s): Valbenazine Tosylate,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Neurocrine Biosciences
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 08, 2025
Lead Product(s) : Valbenazine Tosylate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Neurocrine Biosciences
Deal Size : Inapplicable
Deal Type : Inapplicable
Valbenazine in Obsessive Compulsive Disorder
Details : Valbenazine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Obsessive-Compulsive Disorder.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 08, 2025
Details:
Valbenazine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Schizophrenia.
Lead Product(s): Valbenazine Tosylate,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Other Small Molecule
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 05, 2025
Lead Product(s) : Valbenazine Tosylate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Valbenazine Effectiveness & Safety In Adults with TD On/After VMAT2 Inhibitor
Details : Valbenazine is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Schizophrenia.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
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Details:
Ingrezza (valbenazine) is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. FDA for the treatment adults with tardive dyskinesia.
Lead Product(s): Valbenazine Tosylate,Inapplicable
Therapeutic Area: Neurology Brand Name: Ingrezza
Study Phase: Phase IVProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 27, 2025
Lead Product(s) : Valbenazine Tosylate,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Neurocrine Reports INGREZZA Improves TD Function & QoL
Details : Ingrezza (valbenazine) is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. FDA for the treatment adults with tardive dyskinesia.
Product Name : Ingrezza
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 27, 2025
Details:
Undisclosed
Lead Product(s): Valbenazine Tosylate,Inapplicable
Therapeutic Area: Musculoskeletal Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Neurocrine Biosciences
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 13, 2025
Lead Product(s) : Valbenazine Tosylate,Inapplicable
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Neurocrine Biosciences
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 13, 2025
Details:
Valbenazine generic is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor which is approved by the U.S. FDA for the treatment adults with tardive dyskinesia.
Lead Product(s): Valbenazine Tosylate,Inapplicable
Therapeutic Area: Neurology Brand Name: Ingrezza-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 08, 2024
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Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Zydus Gains Final USFDA Approval for Valbenazine Capsules
Details : Valbenazine generic is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor which is approved by the U.S. FDA for the treatment adults with tardive dyskinesia.
Product Name : Ingrezza-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 08, 2024
Details:
Ingrezza (valbenazine), a new sprinkle formulation of capsules, a selective VMAT2 inhibitor approved by USFDA for treating adults with tardive dyskinesia & chorea associated with Huntington's disease.
Lead Product(s): Valbenazine Tosylate,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Ingrezza
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 30, 2024
Lead Product(s) : Valbenazine Tosylate,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Neurocrine Announces FDA Approval Of INGREZZA® SPRINKLE Capsules
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Product Name : Ingrezza
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 30, 2024
Details:
Undisclosed
Lead Product(s): Valbenazine Tosylate,Inapplicable
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 15, 2024
Lead Product(s) : Valbenazine Tosylate,Inapplicable
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
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Details:
Undisclosed
Lead Product(s): Valbenazine Tosylate,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Other Small Molecule
Sponsor: Neurocrine Biosciences
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 30, 2023
Lead Product(s) : Valbenazine Tosylate,Inapplicable
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Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Neurocrine Biosciences
Deal Size : Inapplicable
Deal Type : Inapplicable
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Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 30, 2023
Details:
Ingrezza (valbenazine) a new sprinkle formulation of capsules PDUFA target action date of April 30, 2024 and it is selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. FDA for the treatment chorea associated with Huntington's disease (HD).
Lead Product(s): Valbenazine Tosylate,Inapplicable
Therapeutic Area: Neurology Brand Name: Ingrezza
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 14, 2023
Lead Product(s) : Valbenazine Tosylate,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Neurocrine Biosciences Announces U.S. FDA Accepts New Drug Application for INGREZZA® (valbenazine...
Details : Ingrezza (valbenazine) a new sprinkle formulation of capsules PDUFA target action date of April 30, 2024 and it is selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. FDA for the treatment chorea associated with Huntington'...
Product Name : Ingrezza
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 14, 2023
Details:
INGREZZA® (valbenazine) Capsules is the selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD).
Lead Product(s): Valbenazine Tosylate,Inapplicable
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Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
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Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Neurocrine Biosciences Announces FDA Approval of INGREZZA® (valbenazine) Capsules for the Treatme...
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Product Name : Ingrezza
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
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3,4-dihydro-6,7-dimethoxyisoquinolinehydrochloride
CAS Number : 20232-39-7
End Use API : Valbenazine Tosylate
About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...
3,4-DIHYDRO-6,7-DIMETHOXY-ISOQUINOLINE HYDROCHLORI...
CAS Number : 20232-39-7
End Use API : Valbenazine Tosylate
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6,7-Dimethoxy-3,4-dihydroisoquinoline HCl
CAS Number : 20232-39-7
End Use API : Valbenazine Tosylate
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CAS Number : 4602-83-9
End Use API : Valbenazine Tosylate
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End Use API : Valbenazine Tosylate
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CAS Number : 120-20-7
End Use API : Valbenazine Tosylate
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End Use API : Valbenazine Tosylate
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(2-Acetyl-4-methyl-pen tyl)trimethylammonium
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End Use API : Valbenazine Tosylate
About The Company : Equilife Laboratories Pvt. Ltd. is an India-based pharmaceutical company, specializing in innovative process development for pharmaceutical products and service...
6,7-Dimethoxy-3,4-dihydro-isoquinoline Hydrochlori...
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End Use API : Valbenazine Tosylate
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End Use API : Valbenazine Tosylate
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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 Tosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Valbenazine Tosylate, including repackagers and relabelers. The FDA regulates Valbenazine Tosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Valbenazine Tosylate 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 Tosylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Valbenazine Tosylate supplier is an individual or a company that provides Valbenazine Tosylate active pharmaceutical ingredient (API) or Valbenazine Tosylate finished formulations upon request. The Valbenazine Tosylate suppliers may include Valbenazine Tosylate API manufacturers, exporters, distributors and traders.
click here to find a list of Valbenazine Tosylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Valbenazine Tosylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Valbenazine Tosylate active pharmaceutical ingredient (API) in detail. Different forms of Valbenazine Tosylate DMFs exist exist since differing nations have different regulations, such as Valbenazine Tosylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Valbenazine Tosylate DMF submitted to regulatory agencies in the US is known as a USDMF. Valbenazine Tosylate USDMF includes data on Valbenazine Tosylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Valbenazine Tosylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Valbenazine Tosylate 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 Tosylate Drug Master File in Korea (Valbenazine Tosylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Valbenazine Tosylate. The MFDS reviews the Valbenazine Tosylate KDMF as part of the drug registration process and uses the information provided in the Valbenazine Tosylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Valbenazine Tosylate 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 Tosylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Valbenazine Tosylate suppliers with KDMF on PharmaCompass.
A Valbenazine Tosylate written confirmation (Valbenazine Tosylate WC) is an official document issued by a regulatory agency to a Valbenazine Tosylate manufacturer, verifying that the manufacturing facility of a Valbenazine Tosylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Valbenazine Tosylate APIs or Valbenazine Tosylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Valbenazine Tosylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Valbenazine Tosylate 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 Tosylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Valbenazine Tosylate 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 Tosylate 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 Tosylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Valbenazine Tosylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Valbenazine Tosylate suppliers with NDC on PharmaCompass.
Valbenazine Tosylate 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 Tosylate 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 Tosylate GMP manufacturer or Valbenazine Tosylate GMP API supplier for your needs.
A Valbenazine Tosylate CoA (Certificate of Analysis) is a formal document that attests to Valbenazine Tosylate's compliance with Valbenazine Tosylate specifications and serves as a tool for batch-level quality control.
Valbenazine Tosylate CoA mostly includes findings from lab analyses of a specific batch. For each Valbenazine Tosylate 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 Tosylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Valbenazine Tosylate EP), Valbenazine Tosylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Valbenazine Tosylate USP).