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Polpharma Trametinib

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ACTIVE PHARMA INGREDIENTS

18 API Suppliers, 6 USDMF, 1 EU WC, 7 NDC API, 15 Listed Suppliers, $ API Reference Price

18 API Suppliers
6 USDMF
1 EU WC
7 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

18 Drugs in Development

18 Drugs in Development

INTERMEDIATES

11 Intermediates Suppliers

11 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

24 FDF Dossiers, 8 FDA Orange Book, 5 Europe, 3 Canada, 6 Australia, 2 South Africa

24 FDF Dossiers
8 FDA Orange Book
5 Europe
3 Canada
6 Australia
2 South Africa

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 0.5MG, TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2MG

drugProductComposition
TABLET;ORAL - EQ 0.5MG
TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 2MG

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DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 48 NEWS #PharmaBuzz

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48 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 5 Finished Drug Prices, 6 Annual Reports

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1 US Medicaid Prescriptions
5 Finished Drug Prices
6 Annual Reports

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PATENTS & EXCLUSIVITIES

87 US Patents, 40 US Exclusivities, 3 Health Canada Patents

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87 US Patents
40 US Exclusivities
3 Health Canada Patents

Polpharma Trametinib

Synopsis

ACTIVE PHARMA INGREDIENTS

18

API Suppliers

6

USDMF

0

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CEP/COS Certifications

0

JDMF

1

EU WC

0

KDMF

7

NDC API

0

VMF

15

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 551,952

MARKET PLACE

3

API

0

FDF

11INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

24

FDF Dossiers

8

FDA Orange Book

FDA (Orange Book)

5

Europe

3

Canada

6

Australia

2

South Africa

0

Listed Dossiers

18DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

PATENTS & EXCLUSIVITIES

87

US Patents

40

US Exclusivities

3

Health Canada Patents

DIGITAL CONTENT

5

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

48

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

159,068,731

Annual Reports (USD Million)

8,845

Finished Drug Prices

184 RELATED EXCIPIENT COMPANIES

316EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 871700-17-3, Gsk1120212, Mekinist, Gsk-1120212, Jtp 74057, Jtp-74057

Molecular Formula

C₂₆H₂₃FIN₅O₄

Molecular Weight

615.4 g/mol

InChI Key

LIRYPHYGHXZJBZ-UHFFFAOYSA-N

FDA UNII

33E86K87QN

Trametinib

Trametinib is an orally bioavailable inhibitor of mitogen-activated protein kinase kinase (MAP2K; MAPK/ERK kinase; MEK) 1 and 2, with potential antineoplastic activity. Upon oral administration, trametinib specifically binds to and inhibits MEK 1 and 2, resulting in an inhibition of growth factor-mediated cell signaling and cellular proliferation in various cancers. MEK 1 and 2, dual specificity serine/threonine and tyrosine kinases often upregulated in various cancer cell types, play a key role in the activation of the RAS/RAF/MEK/ERK signaling pathway that regulates cell growth.

Trametinib is a Kinase Inhibitor. The mechanism of action of trametinib is as a Protein Kinase Inhibitor.

1 2D Structure

Trametinib

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

N-[3-[3-cyclopropyl-5-(2-fluoro-4-iodoanilino)-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1-yl]phenyl]acetamide

2.1.2 InChI

InChI=1S/C26H23FIN5O4/c1-13-22-21(23(31(3)24(13)35)30-20-10-7-15(28)11-19(20)27)25(36)33(17-8-9-17)26(37)32(22)18-6-4-5-16(12-18)29-14(2)34/h4-7,10-12,17,30H,8-9H2,1-3H3,(H,29,34)

2.1.3 InChI Key

LIRYPHYGHXZJBZ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC1=C2C(=C(N(C1=O)C)NC3=C(C=C(C=C3)I)F)C(=O)N(C(=O)N2C4=CC=CC(=C4)NC(=O)C)C5CC5

2.2 Other Identifiers

2.2.1 UNII

33E86K87QN

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Gsk 1120212

2. Gsk-1120212

3. Gsk1120212

4. Jtp 74057

5. Jtp-74057

6. Jtp74057

2.3.2 Depositor-Supplied Synonyms

1. 871700-17-3

2. Gsk1120212

3. Mekinist

4. Gsk-1120212

5. Jtp 74057

6. Jtp-74057

7. Gsk 1120212

8. Trametinib (gsk1120212)

9. N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2h)-yl]phenyl]acetamide

10. Gsk212

11. Tmt212

12. Trametinib [usan]

13. Chebi:75998

14. Tmt-212

15. 33e86k87qn

16. Trametinib (usan)

17. N-(3-{3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2h)-yl}phenyl)acetamide

18. N-[3-[3-cyclopropyl-5-(2-fluoro-4-iodoanilino)-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1-yl]phenyl]acetamide

19. Acetamide, N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-3,4,6,7-tetrahydro-6,8- Dimethyl-2,4,7-trioxopyrido(4,3-d)pyrimidin-1(2h)-yl)phenyl)-

20. N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2h)-yl)phenyl)acetamide

21. Unii-33e86k87qn

22. Trametinib [usan:inn]

23. Trametinibum

24. Jtp74057

25. N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7- Tetrahydropyrido(4,3-d)pyrimidin-1(2h)-yl)phenyl)acetamide

26. N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido(4,3-d)pyrimidin-1(2h)-yl)phenyl)acetamide

27. N-(3-{3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7- Tetrahydropyrido(4,3-d)pyrimidin-1(2h)-yl}phenyl)acetamide

28. Qom

29. Trametinib [mi]

30. Trametinib (gsk1120212jtp 74057)

31. Trametinib [inn]

32. Trametinib [vandf]

33. Trametinib [who-dd]

34. Schembl170938

35. Gtpl6495

36. Gsk1120212 (trametinib)

37. Chembl2103875

38. Ex-a022

39. Bcpp000218

40. Dtxsid901007381

41. Hms3295i05

42. Hms3656j11

43. Bcp02307

44. Bdbm50531540

45. Mfcd17215075

46. Nsc758246

47. Nsc800956

48. S2673

49. Zinc43100709

50. Akos015850628

51. Am90271

52. Ccg-264976

53. Cs-0060

54. Db08911

55. Ex-5957

56. Nsc-758246

57. Nsc-800956

58. Sb16553

59. Ncgc00263180-01

60. Ncgc00263180-07

61. Ncgc00263180-14

62. Ac-25891

63. As-19382

64. Hy-10999

65. N-[3-[3-cyclopropyl-5-(2-fluoro-4-iodo-anilino)-6,8-dimethyl-2,4,7-trioxo-pyrido[4,3-d]pyrimidin-1-yl]phenyl]acetamide

66. Ft-0688438

67. Sw218089-2

68. A25168

69. D10175

70. Gsk1120212 - Jtp-74057

71. Gsk1120212,jtp-74057, Gsk212

72. Sr-01000941589

73. A1-01871

74. J-523325

75. Q7833138

76. Sr-01000941589-1

77. Brd-k12343256-001-01-4

78. Acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2h)-yl]phenyl]-

79. N-(3-(3-cyclopropyl-5-(2-fluoro-4-iodophenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2h)-yl)phenyl)acetamide

80. N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2h)-yl]phe Nyl]acetamide

81. N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-6,8-dimethyl-2,4,7-trioxopyrido[3,4-e]pyrimidin-1-yl]phenyl]acetamide

82. N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodoanilino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2h)-yl]phenyl}ethanimidic Acid

83. N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodophenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2h-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide

2.4 Create Date

2006-10-26

3 Chemical and Physical Properties

Molecular Formula	C₂₆H₂₃FIN₅O₄
Molecular Weight	615.4 g/mol
XLogP3	3.4
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	5
Exact Mass	615.07788 g/mol
Monoisotopic Mass	615.07788 g/mol
Topological Polar Surface Area	102 Å²
Heavy Atom Count	37
Formal Charge	0
Complexity	1090
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Mekinist
PubMed Health	Trametinib (By mouth)
Drug Classes	Antineoplastic Agent
Drug Label	Trametinib dimethyl sulfoxide is a kinase inhibitor. The chemical name is acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4- iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl- 2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]-, compound with 1,1-sul...
Active Ingredient	Trametinib dimethyl sulfoxide
Dosage Form	Tablet
Route	Oral
Strength	eq 1mg non-solvated parent; eq 0.5mg non-solvated parent; eq 2mg non-solvated parent
Market Status	Prescription
Company	Glaxosmithkline

2 of 2
Drug Name	Mekinist
PubMed Health	Trametinib (By mouth)
Drug Classes	Antineoplastic Agent
Drug Label	Trametinib dimethyl sulfoxide is a kinase inhibitor. The chemical name is acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4- iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl- 2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]-, compound with 1,1-sul...
Active Ingredient	Trametinib dimethyl sulfoxide
Dosage Form	Tablet
Route	Oral
Strength	eq 1mg non-solvated parent; eq 0.5mg non-solvated parent; eq 2mg non-solvated parent
Market Status	Prescription
Company	Glaxosmithkline

4.2 Drug Indication

Trametinib is indicated for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test [FDA]. In May 2018, it was approved for use with [DB08912] for the treatment of treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene.

FDA Label

* Melanoma:

Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4. 4 and 5. 1).

Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5. 1).

* Adjuvant treatment of melanoma:

Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.

* Non-small cell lung cancer (NSCLC):

Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Trametinib is an anticancer agent which causes apoptosis (or programmed cell death) and inhibits cell proliferation, which are both important in the treatment of malignancies.

5.2 MeSH Pharmacological Classification

Antineoplastic Agents

Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

Protein Kinase Inhibitors

Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

TRAMETINIB

5.3.2 FDA UNII

33E86K87QN

5.3.3 Pharmacological Classes

Protein Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]

5.4 ATC Code

L01EE01

L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01E - Protein kinase inhibitors

L01EE - Mitogen-activated protein kinase (mek) inhibitors

L01EE01 - Trametinib

5.5 Absorption, Distribution and Excretion

Absorption

Trametinib is readily absorbed. When an oral administration of trametinib was given to patients with BRAF V600 mutation-positive melanoma, peak plasma concentration occurred 1.5 hours post-dose (Tmax). A single 2 mg oral dose has a bioavailability of 72%. When a dose of 2mg/day is given, the peak plasma concentration (Cmax) is 22.2 ng/mL.

Route of Elimination

80% of the dose is excreted in the feces. <20% of the dose is excreted in the urine with <0.1% of the excreted dose in the form of the parent compound.

Volume of Distribution

Apparent volume of distribution (Vd/F) = 214 L

Clearance

Apparent clearance = 4.9 L/h

5.6 Metabolism/Metabolites

Trametinib is metabolized predominantly via deacetylation alone or with mono-oxygenation or in combination with glucuronidation biotransformation pathways in vitro. Deacetylation is likely mediated by hydrolytic enzymes, such as carboxyl-esterases or amidases. The cytochrome P450 enzyme system is not involved with the metabolism of trametinib. The predominant circulating component in the plasma is the parent drug.

5.7 Biological Half-Life

Elimination half-life = 3.9-4.8 days.

5.8 Mechanism of Action

Trametinib is a reversible, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 _(MEK1)_ and _MEK2_ activation and of_ MEK1_ and _MEK2_ kinase activity. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. Trametinib helps with melanoma with the BRAF V600E or V600K as the mutation results in the constitutive activation of the BRAF pathway which includes MEK1 and MEK2.

API SUPPLIERS

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Polpharma

Poland

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API Reference Price

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Number of Transactions

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DOSAGE - TABLET;ORAL - EQ 0.5MG

USFDA APPLICATION NUMBER - 204114

DOSAGE - TABLET;ORAL - EQ 1MG **Federal Regis...DOSAGE - TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 204114

DOSAGE - TABLET;ORAL - EQ 2MG

USFDA APPLICATION NUMBER - 204114

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ABOUT THIS PAGE

Trametinib Manufacturers

A Trametinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trametinib, including repackagers and relabelers. The FDA regulates Trametinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trametinib 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 Trametinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Trametinib Suppliers

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

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

Trametinib USDMF

A Trametinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Trametinib active pharmaceutical ingredient (API) in detail. Different forms of Trametinib DMFs exist exist since differing nations have different regulations, such as Trametinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Trametinib DMF submitted to regulatory agencies in the US is known as a USDMF. Trametinib USDMF includes data on Trametinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trametinib USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Trametinib suppliers with USDMF on PharmaCompass.

Trametinib WC

A Trametinib written confirmation (Trametinib WC) is an official document issued by a regulatory agency to a Trametinib manufacturer, verifying that the manufacturing facility of a Trametinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trametinib APIs or Trametinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Trametinib WC (written confirmation) as part of the regulatory process.

click here to find a list of Trametinib suppliers with Written Confirmation (WC) on PharmaCompass.

Trametinib 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 Trametinib as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Trametinib GMP

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

Trametinib CoA

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

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

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