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Deflazacort

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ACTIVE PHARMA INGREDIENTS

25 API Suppliers, 6 USDMF, 1 EU WC, 7 NDC API, 23 Listed Suppliers, $ API Reference Price

25 API Suppliers
6 USDMF
1 EU WC
7 NDC API
23 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

8 Drugs in Development

8 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

66 FDF Dossiers, 14 FDA Orange Book, 32 Europe, 20 Listed Dossiers

66 FDF Dossiers
14 FDA Orange Book
32 Europe
20 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 18MG, TABLET;ORAL - 30MG, TABLET;ORAL - 36MG, TABLET;ORAL - 6MG, SUSPENSION;ORAL - 22.75MG/ML

drugProductComposition
TABLET;ORAL - 18MG
TABLET;ORAL - 30MG
TABLET;ORAL - 36MG
TABLET;ORAL - 6MG
SUSPENSION;ORAL - 22.75MG/ML

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 5 SPI Pharma, 2 DKSH, 3 Faran Shimi Pharmaceutical, 9 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 3 Actylis, 1 Aeon Procare, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 2 DFE Pharma, 1 Finar, 4 Gangwal Chemicals, 2 Ingredion Pharma Solutions, 15 Kerry, 1 Kima Chemical, 10 Microlex e.U, 1 Nanjing Bold Chemical, 3 Pluviaendo, 1 Prachin Chemical, 17 Roquette, 7 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 4 Sigachi Industries, 1 The Dow Chemical Company, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

46 Fillers, Diluents & Binders, 18 Direct Compression, 14 Solubilizers, 13 Thickeners and Stabilizers, 12 Film Formers & Plasticizers, 11 Lubricants & Glidants, 11 Co-Processed Excipients, 9 Parenteral, 7 Coating Systems & Additives, 7 Taste Masking, 6 Emulsifying Agents, 5 Topical, 5 Rheology Modifiers, 5 Chewable & Orodispersible Aids, 5 Disintegrants & Superdisintegrants, 5 Granulation, 2 Surfactant & Foaming Agents, 2 Controlled & Modified Release, 2 API Stability Enhancers, 1 Soft Gelatin

DIGITAL CONTENT

6 DATA COMPILATION #PharmaFlow, 40 NEWS #PharmaBuzz

media
6 DATA COMPILATION #PharmaFlow
40 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 32 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
32 Finished Drug Prices

MARKET PLACE

27 APIs

marketPlace
27 APIs

PATENTS & EXCLUSIVITIES

10 US Exclusivities

patents
10 US Exclusivities

REF. STANDARDS & IMPURITIES

1 USP , 1 Others

otherSolutions
1 USP
1 Others

Coral Deflazacort

Synopsis

ACTIVE PHARMA INGREDIENTS

25

API Suppliers

6

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

1

EU WC

0

KDMF

7

NDC API

0

VMF

23

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 2,116

MARKET PLACE

27

API

0

FDF

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

66

FDF Dossiers

14

FDA Orange Book

FDA (Orange Book)

32

Europe

0

Canada

0

Australia

0

South Africa

20

Listed Dossiers

8DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

1

USP

0

JP

1

Others

PATENTS & EXCLUSIVITIES

0

US Patents

10

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

6

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

40

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

11,065,608

Annual Reports (USD Million)

NA

Finished Drug Prices

107 RELATED EXCIPIENT COMPANIES

186EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 14484-47-0, Azacort, Calcort, Oxazacort, Flantadin, Emflaza

Molecular Formula

C₂₅H₃₁NO₆

Molecular Weight

441.5 g/mol

InChI Key

FBHSPRKOSMHSIF-GRMWVWQJSA-N

FDA UNII

KR5YZ6AE4B

Deflazacort

Deflazacort is a synthetic glucocorticoid prodrug, with anti-inflammatory and immunomodulating properties. Upon administration, the active metabolite of deflazacort, 21-desacetyl deflazacort, binds to and activates tissue glucocorticoid receptors. This results in the inhibition of specific leukocyte functions and the inhibition of proinflammatory cytokine production.

Deflazacort is a Corticosteroid. The mechanism of action of deflazacort is as a Corticosteroid Hormone Receptor Agonist.

1 2D Structure

Deflazacort

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

[2-[(1S,2S,4R,8S,9S,11S,12S,13R)-11-hydroxy-6,9,13-trimethyl-16-oxo-5-oxa-7-azapentacyclo[10.8.0.02,9.04,8.013,18]icosa-6,14,17-trien-8-yl]-2-oxoethyl] acetate

2.1.2 InChI

InChI=1S/C25H31NO6/c1-13-26-25(20(30)12-31-14(2)27)21(32-13)10-18-17-6-5-15-9-16(28)7-8-23(15,3)22(17)19(29)11-24(18,25)4/h7-9,17-19,21-22,29H,5-6,10-12H2,1-4H3/t17-,18-,19-,21+,22+,23-,24-,25+/m0/s1

2.1.3 InChI Key

FBHSPRKOSMHSIF-GRMWVWQJSA-N

2.1.4 Canonical SMILES

CC1=NC2(C(O1)CC3C2(CC(C4C3CCC5=CC(=O)C=CC45C)O)C)C(=O)COC(=O)C

2.1.5 Isomeric SMILES

CC1=N[C@@]2([C@H](O1)C[C@@H]3[C@@]2(C[C@@H]([C@H]4[C@H]3CCC5=CC(=O)C=C[C@]45C)O)C)C(=O)COC(=O)C

2.2 Other Identifiers

2.2.1 UNII

KR5YZ6AE4B

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Calcort

2. Dezacor

3. Emflaza

4. Zamene

2.3.2 Depositor-Supplied Synonyms

1. 14484-47-0

2. Azacort

3. Calcort

4. Oxazacort

5. Flantadin

6. Emflaza

7. Cortax

8. Deflan

9. Mdl 458

10. Mdl-458

11. L-5458

12. Kr5yz6ae4b

13. Mdl458

14. Dezacor

15. Lantadin

16. Dsstox_cid_378

17. Dsstox_rid_75552

18. Dsstox_gsid_20378

19. 2-((6ar,6bs,7s,8as,8bs,11ar,12as,12bs)-7-hydroxy-6a,8a,10-trimethyl-4-oxo-1,2,4,6a,6b,7,8,8a,11a,12,12a,12b-dodecahydro-8bh-naphtho[2',1':4,5]indeno[1,2-d]oxazol-8b-yl)-2-oxoethyl Acetate

20. Deflazacortum

21. Decortil

22. Deflanil

23. Enzocort

24. Deflazacort (calcort)

25. 2-[(4ar,4bs,5s,6as,6bs,9ar,10as,10bs)-5-hydroxy-4a,6a,8-trimethyl-2-oxo-2,4a,4b,5,6,6a,9a,10,10a,10b,11,12-dodecahydro-6bh-naphtho[2',1':4,5]indeno[1,2-d][1,3]oxazol-6b-yl]-2-oxoethyl Acetate

26. Cas-14484-47-0

27. Dl-458-it

28. Unii-kr5yz6ae4b

29. Deflazacortum [inn-latin]

30. Deflazacort [usan:inn:ban]

31. Einecs 238-483-7

32. Emflaza (tn)

33. Mfcd00866106

34. Deflazacort [mi]

35. Deflazacort [inn]

36. Deflazacort (usan/inn)

37. Deflazacort [usan]

38. Schembl4018

39. Deflazacort [mart.]

40. Deflazacort [usp-rs]

41. Deflazacort [who-dd]

42. Dl-458it

43. Gtpl9477

44. Chembl1201891

45. Dtxsid9020378

46. Deflazacort, >=98% (hplc)

47. Deflazacort [orange Book]

48. Chebi:135720

49. Hms3714d15

50. Bcp08474

51. Zinc4212809

52. Tox21_112506

53. Tox21_301415

54. Bbl036672

55. S1888

56. Stl559051

57. Akos015895199

58. Tox21_112506_1

59. Ccg-220817

60. Db11921

61. Ks-1158

62. Ncgc00255189-01

63. Ncgc00263521-01

64. 11beta,21-dihydroxy-2'-methyl-5'betah-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione 21-acetate

65. Hy-13609

66. Deflazacort 100 Microg/ml In Acetonitrile

67. D4523

68. D03671

69. T70289

70. Ab01274724-01

71. Ab01274724_02

72. 484d470

73. Q779118

74. Q-101371

75. 3-amino-3-(4-chloro-3-nitro-phenyl)-propionicacid

76. Deflazacort, United States Pharmacopeia (usp) Reference Standard

77. 11b,21-dihydroxy-2'-methyl-5'bh-pregna-1,4-dieno[17,16-d]oxazole-3,20-dione 21-acetate

78. (11beta,16beta)-21-(acetyloxy)-11-hydroxy-2'-methyl-5'h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione

79. [2-[(1s,2s,4r,8s,9s,11s,12s,13r)-11-hydroxy-6,9,13-trimethyl-16-oxo-5-oxa-7-azapentacyclo[10.8.0.02,9.04,8.013,18]icosa-6,14,17-trien-8-yl]-2-oxoethyl] Acetate

80. 11.beta.,21-dihydroxy-2'-methyl-5'.beta.h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione 21-acetate

81. 2-((6ar,6bs,7s,8as,8bs,11ar,12as,12bs)-7-hydroxy-6a,8a,10-trimethyl-4-oxo-2,4,6a,6b,7,8,8a,8b,11a,12,12a,12b-dodecahydro-1h-naphtho[2',1':4,5]indeno[1,2-d]oxazol-8b-yl)-2-oxoethyl Acetate

82. 5'-beta-h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione, 11-beta,21-dihydroxy-2'-methyl-, 21-acetate

83. 5'h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione, 21-(acetyloxy)-11-hydroxy-2'-methyl-, (11.beta.,16.beta.)-

84. 5'h-pregna-1,4-dieno(17,16-d)oxazole-3,20-dione, 21-(acetyloxy)-11-hydroxy-2'-methyl-, (11beta,16beta)-

2.4 Create Date

2005-08-09

3 Chemical and Physical Properties

Molecular Formula	C₂₅H₃₁NO₆
Molecular Weight	441.5 g/mol
XLogP3	2
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	4
Exact Mass	441.21513771 g/mol
Monoisotopic Mass	441.21513771 g/mol
Topological Polar Surface Area	102 Å²
Heavy Atom Count	32
Formal Charge	0
Complexity	996
Isotope Atom Count	0
Defined Atom Stereocenter Count	8
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 Indication

Deflazacort is indicated for the treatment of Duchenne Muscular Dystrophy (DMD) in patients 2 years of age and older.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Deflazacort exerts anti-inflammatory activity in DMD, likely improving various symptoms, including muscle weakness and cardiorespiratory symptoms in addition to delaying their onset. This allows for an increased quality of life and prevents the necessity for surgical procedures, such as those for scoliosis, which is associated with DMD. Studies showed significant preservation of muscle mass in patients generally treated with 0.9 mg/kg/day of deflazacort compared to a control group. The following findings are based on clinical studies using deflazacort on a long term basis: **Effects on muscle strength** At age 16, individuals treated with long-term deflazacort had 63 4% score in muscle strength compared to a mean muscle strength score of 31 3% for control patients. Significant improvements in climbing stairs and rising from a supine position were also seen in patients taking deflazacort. **Effects on ambulation** Ambulation was significantly higher by 12 years of age and 18 years of age in patients taking deflazacort when compared with the control group. The control group showed a mean loss of ambulation of 2 years sooner than with deflazacort treatment. **Effects on cardiac function** Mean left ventricular ejection fraction (a measure of cardiac function) was higher in patients treated with deflazacort over the long term. Preservation of cardiac function was demonstrated by a mean difference in ejection fraction of about 7%, favoring study groups taking deflazacort over control groups. **Effects on spinal alignment** Children treated with deflazacort also significantly lowered the rate and severity of scoliosis and eliminated the need for scoliosis surgery after long-term treatment.

5.2 MeSH Pharmacological Classification

Anti-Inflammatory Agents

Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)

Immunosuppressive Agents

Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

DEFLAZACORT

5.3.2 FDA UNII

KR5YZ6AE4B

5.3.3 Pharmacological Classes

Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]

5.4 ATC Code

H02AB13

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

H - Systemic hormonal preparations, excl. sex hormones and insulins

H02 - Corticosteroids for systemic use

H02A - Corticosteroids for systemic use, plain

H02AB - Glucocorticoids

H02AB13 - Deflazacort

5.5 Absorption, Distribution and Excretion

Absorption

Deflazacort is rapidly absorbed after oral administration with peak concentration occurring within 1-2 hours. One pharmacokinetic study determined an AUC (area under the curve) of 280 ng/ml h. The bioavailability of both the oral suspension and tablet are similar. In clinical studies, coadministration of deflazacort crushed with food or applesauce did not affect absorption or bioavailability.

Route of Elimination

Urinary excretion is the major route of deflazacort elimination, accounting for about about 70% of the excreted dose. The remainder of the dose (about 30%) is excreted in the feces. Elimination is almost completed by 24 hours post-dose. 21-deflazacort makes up about 18% of the eliminated drug in the urine.

Volume of Distribution

One study determined the volume of distribution to be 204 84 L.

Clearance

114 27 L/h, according to one noncompartmental pharmacokinetic study. The clearance of corticosteroids is enhanced in hypothyroid patients and increased in patients with hyperthyroidism. Dosing adjustments may be considered according to thyroid status. A study of corticosteroid clearance was performed in patients with a creatinine clearance of 15 mL/min or less, and determined that the active metabolite of deflazacort, 21-deflazacort was similar to that in patients with normal renal clearance.

5.6 Metabolism/Metabolites

After oral ingestion, deflazacort is deacetylated at position 21 by plasma esterases, producing the active metabolite 21-deflazacort. 21-deflazacort is then further metabolized by CYP3A4 to inactive metabolite products. Deflazacort 21-OH metabolism is extensive. The metabolite of deflazacort-21-OH is deflazacort 6-beta-OH.

5.7 Biological Half-Life

The half-life of deflazacort ranges from 1.1 to 1.9 h

5.8 Mechanism of Action

Deflazacort is a corticosteroid prodrug with an active metabolite, 21-deflazacort, which binds to the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects on the body. The exact mechanism by which deflazacort exerts its therapeutic effects in patients with DMD is unknown but likely occurs via its anti-inflammatory activities.

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET;ORAL - 18MG

USFDA APPLICATION NUMBER - 208684

DOSAGE - TABLET;ORAL - 30MG

USFDA APPLICATION NUMBER - 208684

DOSAGE - TABLET;ORAL - 36MG

USFDA APPLICATION NUMBER - 208684

DOSAGE - TABLET;ORAL - 6MG

USFDA APPLICATION NUMBER - 208684

DOSAGE - SUSPENSION;ORAL - 22.75MG/ML

USFDA APPLICATION NUMBER - 208685

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ABOUT THIS PAGE

Deflazacort Manufacturers

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

Deflazacort Suppliers

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

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

Deflazacort USDMF

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

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

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

Deflazacort WC

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

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

Deflazacort 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 Deflazacort as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Deflazacort GMP

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

Deflazacort CoA

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

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

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