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1. Dimesylate, Lis-dexamfetamine
2. Dimesylate, Lisdexamfetamine
3. Elvanse
4. Lis Dexamfetamine Dimesylate
5. Lis-dexamfetamine Dimesylate
6. Lisdexamfetamine
7. Nrp 104
8. Nrp-104
9. Nrp104
10. Vyvanse
1. Vyvanse
2. 608137-33-3
3. Nrp-104
4. Lisdexamfetamine Mesilate
5. Spd489
6. Tyvense
7. Nrp104
8. Spd-489
9. Lisdexamfetamine Dimesylate [usan]
10. Lisdexamfetamine Dimesilate
11. Sjt761gegs
12. Lisdexamphetamine Dimesilate
13. L-lysine-d-amphetamine Dimesylate
14. Lisdexamfetamine Dimethanesulfonate
15. (2s)-2,6-diamino-n-[(1s)-1-methyl-2-phenylethyl]hexanamide Dimethanesulfonate
16. Lis-dexamfetamine Dimesylate
17. Lisdexamfetamine Mesilate (jan)
18. Lisdexamfetamine Dimesylate (usan)
19. Lisdexamfetamine Mesylate
20. Nrp 104
21. Lisdexamfetamine Mesilate [jan]
22. (2s)-2,6-diamino-n-[(2s)-1-phenylpropan-2-yl]hexanamide;methanesulfonic Acid
23. Unii-sjt761gegs
24. Venvanse
25. (2s)-2,6-diamino-n-((1s)-1-methyl-2-phenylethyl)hexanamide Dimethanesulfonate
26. Lys-amp
27. Spd 489
28. Lys-d-amp
29. Elvanse (tn)
30. Vyvanse (tn)
31. Schembl678421
32. Chembl1201178
33. Dtxsid60209653
34. Lisdexamfetamine Dimesylate Solution
35. Bcp24044
36. Akos030254940
37. Lisdexamfetamine Mesilate [mart.]
38. Ldx
39. Lisdexamfetamine Mesilate [who-dd]
40. Lisdexamfetamine Dimesylate [vandf]
41. D04747
42. Lisdexamfetamine Dimethanesulfonate [mi]
43. Lisdexamfetamine Dimesylate [orange Book]
44. 137l333
45. Q27289243
46. (2s)-2,6-diamino-n-((1s)-1-methyl-2-phenylethyl)hexanamide Dimethanesulphonate
47. Hexanamide, 2,6-diamino-n-((1s)-1-methyl-2-phenylethyl), (2s), Dimethanesulfonate
48. Hexanamide, 2,6-diamino-n-((1s)-1-methyl-2-phenylethyl), (2s), Dimethanesulphonate
49. Ldx;lisdexamfetamine Mesilate;lisdexamfetamine Mesylate;nrp 104;nrp-104;spd 489
50. Lisdexamfetamine Dimesylate Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material
Molecular Weight | 455.6 g/mol |
---|---|
Molecular Formula | C17H33N3O7S2 |
Hydrogen Bond Donor Count | 5 |
Hydrogen Bond Acceptor Count | 9 |
Rotatable Bond Count | 8 |
Exact Mass | 455.17599275 g/mol |
Monoisotopic Mass | 455.17599275 g/mol |
Topological Polar Surface Area | 207 Ų |
Heavy Atom Count | 29 |
Formal Charge | 0 |
Complexity | 344 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 3 |
1 of 4 | |
---|---|
Drug Name | Lisdexamfetamine dimesylate |
Drug Label | Vyvanse (lisdexamfetamine dimesylate), a CNS stimulant,isa capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate.... |
Active Ingredient | Lisdexamfetamine dimesylate |
Dosage Form | Capsule |
Route | Oral |
Strength | 30mg; 50mg; 60mg; 40mg; 70mg; 20mg |
Market Status | Tentative Approval |
Company | Mylan Pharms; Amneal Pharms; Roxane |
2 of 4 | |
---|---|
Drug Name | Vyvanse |
PubMed Health | Amphetamine (By mouth) |
Drug Classes | Amphetamine |
Drug Label | Vyvanse (lisdexamfetamine dimesylate), a CNS stimulant,isa capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate.... |
Active Ingredient | Lisdexamfetamine dimesylate |
Dosage Form | Capsule |
Route | Oral |
Strength | 30mg; 50mg; 60mg; 40mg; 20mg; 70mg |
Market Status | Prescription |
Company | Shire Development |
3 of 4 | |
---|---|
Drug Name | Lisdexamfetamine dimesylate |
Drug Label | Vyvanse (lisdexamfetamine dimesylate), a CNS stimulant,isa capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate.... |
Active Ingredient | Lisdexamfetamine dimesylate |
Dosage Form | Capsule |
Route | Oral |
Strength | 30mg; 50mg; 60mg; 40mg; 70mg; 20mg |
Market Status | Tentative Approval |
Company | Mylan Pharms; Amneal Pharms; Roxane |
4 of 4 | |
---|---|
Drug Name | Vyvanse |
PubMed Health | Amphetamine (By mouth) |
Drug Classes | Amphetamine |
Drug Label | Vyvanse (lisdexamfetamine dimesylate), a CNS stimulant,isa capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate.... |
Active Ingredient | Lisdexamfetamine dimesylate |
Dosage Form | Capsule |
Route | Oral |
Strength | 30mg; 50mg; 60mg; 40mg; 20mg; 70mg |
Market Status | Prescription |
Company | Shire Development |
Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
Central Nervous System Stimulants
A loosely defined group of drugs that tend to increase behavioral alertness, agitation, or excitation. They work by a variety of mechanisms, but usually not by direct excitation of neurons. The many drugs that have such actions as side effects to their main therapeutic use are not included here. (See all compounds classified as Central Nervous System Stimulants.)
Dopamine Uptake Inhibitors
Drugs that block the transport of DOPAMINE into axon terminals or into storage vesicles within terminals. Most of the ADRENERGIC UPTAKE INHIBITORS also inhibit dopamine uptake. (See all compounds classified as Dopamine Uptake Inhibitors.)
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-01-28
Pay. Date : 2020-01-21
DMF Number : 22442
Submission : 2009-01-27
Status : Active
Type : II
NDC Package Code : 49812-0186
Start Marketing Date : 2012-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-12-30
Pay. Date : 2021-11-18
DMF Number : 35645
Submission : 2021-11-23
Status : Active
Type : II
NDC Package Code : 51634-2058
Start Marketing Date : 2021-12-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-21
Pay. Date : 2023-10-12
DMF Number : 38874
Submission : 2023-10-20
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-07-02
Pay. Date : 2018-05-22
DMF Number : 32289
Submission : 2018-05-18
Status : Active
Type : II
NDC Package Code : 61960-0300
Start Marketing Date : 2018-03-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-07-28
Pay. Date : 2020-06-03
DMF Number : 34823
Submission : 2020-05-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36325
Submission : 2021-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38667
Submission : 2023-08-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32210
Submission : 2017-11-22
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-21
Pay. Date : 2023-10-12
DMF Number : 38874
Submission : 2023-10-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-28
Pay. Date : 2020-01-21
DMF Number : 22442
Submission : 2009-01-27
Status : Active
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-30
Pay. Date : 2021-11-18
DMF Number : 35645
Submission : 2021-11-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38667
Submission : 2023-08-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36325
Submission : 2021-10-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20103
Submission : 2006-12-29
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-02
Pay. Date : 2018-05-22
DMF Number : 32289
Submission : 2018-05-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32210
Submission : 2017-11-22
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-07-28
Pay. Date : 2020-06-03
DMF Number : 34823
Submission : 2020-05-29
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35754
Submission : 2021-05-28
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Lisdexamphetamine dimesilate INH
Date of Issue : 2022-09-01
Valid Till : 2025-07-28
Written Confirmation Number : WC-0046
Address of the Firm : Plot No. E-21, E-22/1, MIDC, Mahad, Dist. Raigad-402 309, Maharashtra
Lisdexamfetamine Dimesylate IH
Date of Issue : 2022-06-03
Valid Till : 2025-05-27
Written Confirmation Number : WC-0003
Address of the Firm : Vill.- Bhagwanpur, Barwala Road, Near Dera Bassi, Distt.- SAS Nagar (Mohali), Pu...
NDC Package Code : 49812-0186
Start Marketing Date : 2012-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
NDC Package Code : 51634-2058
Start Marketing Date : 2021-12-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17180-1100
Start Marketing Date : 2007-02-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (18kg/18kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 59116-3012
Start Marketing Date : 2014-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59116-3010
Start Marketing Date : 2012-10-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59116-3011
Start Marketing Date : 2013-07-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 59116-3013
Start Marketing Date : 2016-10-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 61960-0300
Start Marketing Date : 2018-03-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65392-0118
Start Marketing Date : 2007-02-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 53834-401
Start Marketing Date : 2023-10-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...
About the Company : Back in the year 1973, a team of individuals came up with such an idea – The idea called Alkem. Looking back at our 5 decades, illustrious journey, that one small idea has Not on...
About the Company : Established in 2016, a state-of-the-art R&D facility engaged in the development of Novel processes for Bulk Actives including Deuterated Actives, Advanced Intermediates and up the ...
About the Company : At Embio, technology is the foundation of our success, driving leadership in every product we manufacture. With 30+ years of expertise in bacterial, fungal, and Category 1 GMO biot...
About the Company : J&H CHEM is one of China's leading providers of integrated fine chemical services including offering, research and development, Custom manufacturing business, as well as other Valu...
About the Company : Founded in 1997, Lee Pharma Limited has transformed from a small venture into a global leader in the pharmaceutical industry. Our journey began with a commitment to providing affor...
About the Company : Established in 1991, SM Biomed is a joint venture company pioneering the manufacture of API (active pharmaceutical ingredients) products in Malaysia. Company has grown several fold...
Details:
Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications and currently are on the FDA's drug shortage list.
Lead Product(s): Lisdexamfetamine Dimesylate
Therapeutic Area: Psychiatry/Psychology Brand Name: Vyvanse-Generic
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 31, 2023
Lead Product(s) : Lisdexamfetamine Dimesylate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Lisdexamfetamine Dimesylate Capsules are a federally controlled substance (CII) used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) and other indications and currently are on the FDA's drug shortage list.
Product Name : Vyvanse-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
August 31, 2023
Details:
Lisdexamfetamine dimesylate capsules, for oral use is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder and Moderate to Severe Binge Eating Disorder (BED) in adults.
Lead Product(s): Lisdexamfetamine Dimesylate
Therapeutic Area: Psychiatry/Psychology Brand Name: Vyvanse-Generic
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 09, 2023
Lead Product(s) : Lisdexamfetamine Dimesylate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Amneal Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate
Details : Lisdexamfetamine dimesylate capsules, for oral use is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder and Moderate to Severe Binge Eating Disorder (BED) in adults.
Product Name : Vyvanse-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
June 09, 2023
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PharmaCompass offers a list of Lisdexamfetamine Dimesylate 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 Lisdexamfetamine Dimesylate manufacturer or Lisdexamfetamine Dimesylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lisdexamfetamine Dimesylate manufacturer or Lisdexamfetamine Dimesylate supplier.
PharmaCompass also assists you with knowing the Lisdexamfetamine Dimesylate API Price utilized in the formulation of products. Lisdexamfetamine Dimesylate API Price is not always fixed or binding as the Lisdexamfetamine Dimesylate Price is obtained through a variety of data sources. The Lisdexamfetamine Dimesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Vyvanse manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vyvanse, including repackagers and relabelers. The FDA regulates Vyvanse manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vyvanse 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 Vyvanse manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vyvanse supplier is an individual or a company that provides Vyvanse active pharmaceutical ingredient (API) or Vyvanse finished formulations upon request. The Vyvanse suppliers may include Vyvanse API manufacturers, exporters, distributors and traders.
click here to find a list of Vyvanse suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vyvanse DMF (Drug Master File) is a document detailing the whole manufacturing process of Vyvanse active pharmaceutical ingredient (API) in detail. Different forms of Vyvanse DMFs exist exist since differing nations have different regulations, such as Vyvanse USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vyvanse DMF submitted to regulatory agencies in the US is known as a USDMF. Vyvanse USDMF includes data on Vyvanse's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vyvanse USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vyvanse suppliers with USDMF on PharmaCompass.
A Vyvanse written confirmation (Vyvanse WC) is an official document issued by a regulatory agency to a Vyvanse manufacturer, verifying that the manufacturing facility of a Vyvanse active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vyvanse APIs or Vyvanse finished pharmaceutical products to another nation, regulatory agencies frequently require a Vyvanse WC (written confirmation) as part of the regulatory process.
click here to find a list of Vyvanse 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 Vyvanse as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vyvanse 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 Vyvanse 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 Vyvanse and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vyvanse NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vyvanse suppliers with NDC on PharmaCompass.
Vyvanse 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 Vyvanse 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 Vyvanse GMP manufacturer or Vyvanse GMP API supplier for your needs.
A Vyvanse CoA (Certificate of Analysis) is a formal document that attests to Vyvanse's compliance with Vyvanse specifications and serves as a tool for batch-level quality control.
Vyvanse CoA mostly includes findings from lab analyses of a specific batch. For each Vyvanse 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.
Vyvanse may be tested according to a variety of international standards, such as European Pharmacopoeia (Vyvanse EP), Vyvanse JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vyvanse USP).