Find Tesofensine manufacturers, exporters & distributors on PharmaCompass

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CEP/COS

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0INTERMEDIATES

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Chemistry

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Also known as: 195875-84-4, Ns-2330, Tesofensine [inn], Ns 2330, Blh9ukx9v1, (1r,2r,3s,5s)-3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-8-azabicyclo[3.2.1]octane
Molecular Formula
C17H23Cl2NO
Molecular Weight
328.3  g/mol
InChI Key
VCVWXKKWDOJNIT-ZOMKSWQUSA-N
FDA UNII
BLH9UKX9V1

Tesofensine
1 2D Structure

Tesofensine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1R,2R,3S,5S)-3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-8-azabicyclo[3.2.1]octane
2.1.2 InChI
InChI=1S/C17H23Cl2NO/c1-3-21-10-14-13(9-12-5-7-17(14)20(12)2)11-4-6-15(18)16(19)8-11/h4,6,8,12-14,17H,3,5,7,9-10H2,1-2H3/t12-,13+,14+,17+/m0/s1
2.1.3 InChI Key
VCVWXKKWDOJNIT-ZOMKSWQUSA-N
2.1.4 Canonical SMILES
CCOCC1C2CCC(N2C)CC1C3=CC(=C(C=C3)Cl)Cl
2.1.5 Isomeric SMILES
CCOC[C@H]1[C@H]2CC[C@H](N2C)C[C@@H]1C3=CC(=C(C=C3)Cl)Cl
2.2 Other Identifiers
2.2.1 UNII
BLH9UKX9V1
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (1r-(2-endo,3-exo))-3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-8-azabicyclo(3,2,1)octane-2-hydroxy-1,2,3-propanetricarboxylate

2.3.2 Depositor-Supplied Synonyms

1. 195875-84-4

2. Ns-2330

3. Tesofensine [inn]

4. Ns 2330

5. Blh9ukx9v1

6. (1r,2r,3s,5s)-3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-8-azabicyclo[3.2.1]octane

7. (1r,2r,3s,5s)-3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-8-azabicyclo(3.2.1)octane

8. Unii-blh9ukx9v1

9. Tesofensine [mi]

10. Tesofensine [mart.]

11. Schembl37509

12. Tesofensine [who-dd]

13. Chembl3989690

14. Dtxsid70905114

15. Zinc3953158

16. Ns2330

17. Db06156

18. Hy-14472

19. Cs-0003378

20. J-012675

21. Q7705544

22. (1r,2r,3s)-2-ethoxymethyl-3-(3,4-dichlorophenyl)tropane

23. (1r, 2r, 3s)-2-ethoxymethyl-3-(3,4-dichlorophenyl)tropane

24. (1r-(2-endo,3-exo))-3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-8-azabicyclo(3,2,1)octane-2-hydroxy-1,2,3-propanetricarboxylate

25. 8-azabicyclo(3.2.1)octane, 3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-, (1r-(2-endo,3-exo))-

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 328.3 g/mol
Molecular Formula C17H23Cl2NO
XLogP34.5
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count2
Rotatable Bond Count4
Exact Mass327.1156697 g/mol
Monoisotopic Mass327.1156697 g/mol
Topological Polar Surface Area12.5 Ų
Heavy Atom Count21
Formal Charge0
Complexity354
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Investigated for use/treatment in alzheimer's disease, parkinson's disease, and obesity.


5 Pharmacology and Biochemistry
5.1 Mechanism of Action

Tesofensine is a Serotonin-norepinephrine-dopamine-reuptake-inhibitor (SNDRI). SNDRIs are a class of psychoactive antidepressants. They act upon neurotransmitters in the brain, namely, serotonin, norepinephrine and dopamine. These three biogenic monoamines are associated with depression and increasing the availability in the brain is one method used to treat the condition.


API SUPPLIERS

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01

Biopeptek Pharmaceuticals

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

China Battery Fair
Not Confirmed
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Biopeptek Pharmaceuticals

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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China Battery Fair
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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02

Darmerica

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

China Battery Fair
Not Confirmed
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Darmerica

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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China Battery Fair
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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03

Cambrex Corporation

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

China Battery Fair
Not Confirmed
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Cambrex Corporation

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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China Battery Fair
Not Confirmed
USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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NDC API

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TESOFENSINE

NDC Package Code : 73212-039

Start Marketing Date : 2022-01-03

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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China Battery Fair
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TESOFENSINE CITRATE

NDC Package Code : 12651-121

Start Marketing Date : 2021-01-19

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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TESOFENSINE

NDC Package Code : 71052-207

Start Marketing Date : 2022-07-26

End Marketing Date : 2025-12-31

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

Marketing Category : BULK INGREDIENT

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Drugs in Development

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Details:

Tesomet (tesofensine), is a novel, proprietary molecule, and investigational fixed-dose combination therapy of, a triple monoamine reuptake inhibitor and metoprolol (a beta-1 selective blocker).


Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Nutrition and Weight Loss Brand Name: Tesomet

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 23, 2022

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Saniona

Denmark
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Not Confirmed

Saniona

Denmark
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Details : Tesomet (tesofensine), is a novel, proprietary molecule, and investigational fixed-dose combination therapy of, a triple monoamine reuptake inhibitor and metoprolol (a beta-1 selective blocker).

Product Name : Tesomet

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 23, 2022

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Details:

Tesomet (Tesofensine) is a serotonin–noradrenaline–dopamine reuptake inhibitor from the phenyltropane family of drugs, which is being developed for the treatment of obesity.


Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Genetic Disease Brand Name: Tesomet

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 20, 2022

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02

Saniona

Denmark
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China Battery Fair
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Saniona

Denmark
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Not Confirmed

Details : Tesomet (Tesofensine) is a serotonin–noradrenaline–dopamine reuptake inhibitor from the phenyltropane family of drugs, which is being developed for the treatment of obesity.

Product Name : Tesomet

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 20, 2022

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Details:

Adult patients receiving Tesomet achieved a statistically significant reduction in hyperphagia, as well as a reduction in body weight. Adolescent patients demonstrated dose-dependent reductions in hyperphagia and body weight in open-label extensions of the study.


Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Genetic Disease Brand Name: Tesomet

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 28, 2021

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03

Saniona

Denmark
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China Battery Fair
Not Confirmed

Saniona

Denmark
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Not Confirmed

Details : Adult patients receiving Tesomet achieved a statistically significant reduction in hyperphagia, as well as a reduction in body weight. Adolescent patients demonstrated dose-dependent reductions in hyperphagia and body weight in open-label extensions of t...

Product Name : Tesomet

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 28, 2021

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Details:

The initiation of this Phase 2b clinical trial of tesomet represents the culmination of the significant work and primary endpoint of study is the percentage change in body weight from baseline to week 36.


Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Nutrition and Weight Loss Brand Name: Tesomet

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 17, 2021

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04

Saniona

Denmark
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China Battery Fair
Not Confirmed

Saniona

Denmark
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China Battery Fair
Not Confirmed

Details : The initiation of this Phase 2b clinical trial of tesomet represents the culmination of the significant work and primary endpoint of study is the percentage change in body weight from baseline to week 36.

Product Name : Tesomet

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 17, 2021

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Details:

Tesomet capsules contain two active ingredients as microspheres of fixed-dose combination therapy of tesofensine (triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker) used for treatment for hypothalamic obesity and Prader-Willi syndrome.


Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Genetic Disease Brand Name: Tesomet

Study Phase: Phase IProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 18, 2021

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05

Saniona

Denmark
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China Battery Fair
Not Confirmed

Saniona

Denmark
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China Battery Fair
Not Confirmed

Details : Tesomet capsules contain two active ingredients as microspheres of fixed-dose combination therapy of tesofensine (triple monoamine reuptake inhibitor) and metoprolol (a beta-1 selective blocker) used for treatment for hypothalamic obesity and Prader-Will...

Product Name : Tesomet

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 18, 2021

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Details:

Adults receiving Tesomet demonstrated statistically significant reductions in body weight and improvements in waist circumference and glycemic control.


Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Nutrition and Weight Loss Brand Name: Tesomet

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 26, 2021

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06

Saniona

Denmark
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China Battery Fair
Not Confirmed

Saniona

Denmark
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China Battery Fair
Not Confirmed

Details : Adults receiving Tesomet demonstrated statistically significant reductions in body weight and improvements in waist circumference and glycemic control.

Product Name : Tesomet

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 26, 2021

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Details:

The company requested FDA feedback, and the FDA agreed with the company’s proposal but requested additional information regarding Tesomet manufacturing.


Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Genetic Disease Brand Name: Tesomet

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 21, 2021

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07

Saniona

Denmark
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China Battery Fair
Not Confirmed

Saniona

Denmark
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Details : The company requested FDA feedback, and the FDA agreed with the company’s proposal but requested additional information regarding Tesomet manufacturing.

Product Name : Tesomet

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 21, 2021

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Details:

Saniona is currently planning to initiate a Phase 2b study of Tesomet in PWS in the first half of 2021. Saniona is also evaluating Tesomet for the treatment of hypothalamic obesity (HO) and plans to begin a Phase 2b trial in this indication in the first half of this year.


Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Genetic Disease Brand Name: Tesomet

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Foundation for Prader-Willi Research

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership April 19, 2021

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Saniona

Denmark
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China Battery Fair
Not Confirmed

Saniona

Denmark
arrow
China Battery Fair
Not Confirmed

Details : Saniona is currently planning to initiate a Phase 2b study of Tesomet in PWS in the first half of 2021. Saniona is also evaluating Tesomet for the treatment of hypothalamic obesity (HO) and plans to begin a Phase 2b trial in this indication in the first ...

Product Name : Tesomet

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

April 19, 2021

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Details:

Saniona is preparing to start a Phase 2b study of Tesomet in Prader-Willi Syndrome this year. In a Phase 2a trial, adults patients receiving Tesomet achieved a significant reduction in hyperphagia and a clinically meaningful reduction in body weight at a dose of 0.5 mg/day.


Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Genetic Disease Brand Name: Tesomet

Study Phase: Phase IProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 03, 2021

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09

Saniona

Denmark
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China Battery Fair
Not Confirmed

Saniona

Denmark
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Not Confirmed

Details : Saniona is preparing to start a Phase 2b study of Tesomet in Prader-Willi Syndrome this year. In a Phase 2a trial, adults patients receiving Tesomet achieved a significant reduction in hyperphagia and a clinically meaningful reduction in body weight at a...

Product Name : Tesomet

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 03, 2021

blank

Details:

Tesomet was well-tolerated in hypothalamic obesity patients throughout the duration of the 48-week trial, with no clinically meaningful differences in heart rate or blood pressure observed. All patients who entered the OLE study completed it.


Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Nutrition and Weight Loss Brand Name: Tesomet

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 23, 2020

blank

10

Saniona

Denmark
arrow
China Battery Fair
Not Confirmed

Saniona

Denmark
arrow
China Battery Fair
Not Confirmed

Details : Tesomet was well-tolerated in hypothalamic obesity patients throughout the duration of the 48-week trial, with no clinically meaningful differences in heart rate or blood pressure observed. All patients who entered the OLE study completed it.

Product Name : Tesomet

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 23, 2020

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NEWS #PharmaBuzz

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https://www.globenewswire.com/news-release/2021/12/28/2358524/0/en/Saniona-Initiates-Phase-2b-Clinical-Trial-of-Tesomet-for-Prader-Willi-Syndrome.html

GLOBENEWSWIRE
28 Dec 2021

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ABOUT THIS PAGE

Looking for 195875-84-4 / Tesofensine API manufacturers, exporters & distributors?

Tesofensine manufacturers, exporters & distributors 1

46

PharmaCompass offers a list of Tesofensine 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 Tesofensine manufacturer or Tesofensine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tesofensine manufacturer or Tesofensine supplier.

PharmaCompass also assists you with knowing the Tesofensine API Price utilized in the formulation of products. Tesofensine API Price is not always fixed or binding as the Tesofensine Price is obtained through a variety of data sources. The Tesofensine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Tesofensine

Synonyms

195875-84-4, Ns-2330, Tesofensine [inn], Ns 2330, Blh9ukx9v1, (1r,2r,3s,5s)-3-(3,4-dichlorophenyl)-2-(ethoxymethyl)-8-methyl-8-azabicyclo[3.2.1]octane

Cas Number

195875-84-4

Unique Ingredient Identifier (UNII)

BLH9UKX9V1

Tesofensine Manufacturers

A Tesofensine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tesofensine, including repackagers and relabelers. The FDA regulates Tesofensine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tesofensine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Tesofensine Suppliers

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

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

Tesofensine 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 Tesofensine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Tesofensine GMP

Tesofensine 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 Tesofensine 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 Tesofensine GMP manufacturer or Tesofensine GMP API supplier for your needs.

Tesofensine CoA

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

Tesofensine CoA mostly includes findings from lab analyses of a specific batch. For each Tesofensine 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.

Tesofensine may be tested according to a variety of international standards, such as European Pharmacopoeia (Tesofensine EP), Tesofensine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tesofensine 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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