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Chemistry

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Also known as: 722533-56-4, Rad1901, Elacestrant [inn], Elacestrant [usan], Rad-1901, Er-306323
Molecular Formula
C30H38N2O2
Molecular Weight
458.6  g/mol
InChI Key
SIFNOOUKXBRGGB-AREMUKBSSA-N
FDA UNII
FM6A2627A8

Elacestrant
Elacestrant is an orally available, selective estrogen receptor degrader (SERD) and selective estrogen receptor modulator (SERM), with potential antineoplastic and estrogen-like activities. Upon oral administration of higher doses of elacestrant, this agent acts as a SERD, which binds to the estrogen receptor (ER) and induces a conformational change that results in the degradation of the receptor. This may inhibit the growth and survival of ER-expressing cancer cells. At lower doses of this agent, RAD1901 acts as a SERM and has estrogen-like effects in certain tissues, which can both reduce hot flashes and protect against bone loss. In addition, elacestrant is able to cross the blood-brain barrier (BBB).
1 2D Structure

Elacestrant

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(6R)-6-[2-[ethyl-[[4-[2-(ethylamino)ethyl]phenyl]methyl]amino]-4-methoxyphenyl]-5,6,7,8-tetrahydronaphthalen-2-ol
2.1.2 InChI
InChI=1S/C30H38N2O2/c1-4-31-17-16-22-6-8-23(9-7-22)21-32(5-2)30-20-28(34-3)14-15-29(30)26-11-10-25-19-27(33)13-12-24(25)18-26/h6-9,12-15,19-20,26,31,33H,4-5,10-11,16-18,21H2,1-3H3/t26-/m1/s1
2.1.3 InChI Key
SIFNOOUKXBRGGB-AREMUKBSSA-N
2.1.4 Canonical SMILES
CCNCCC1=CC=C(C=C1)CN(CC)C2=C(C=CC(=C2)OC)C3CCC4=C(C3)C=CC(=C4)O
2.1.5 Isomeric SMILES
CCNCCC1=CC=C(C=C1)CN(CC)C2=C(C=CC(=C2)OC)[C@@H]3CCC4=C(C3)C=CC(=C4)O
2.2 Other Identifiers
2.2.1 UNII
FM6A2627A8
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (6r)-6-(2-(ethyl((4-(2-(ethylamino)ethyl)phenyl)methyl)amino)-4-methoxyphenyl)-5,6,7,8-tetrahydronaphthalen-2-ol

2.3.2 Depositor-Supplied Synonyms

1. 722533-56-4

2. Rad1901

3. Elacestrant [inn]

4. Elacestrant [usan]

5. Rad-1901

6. Er-306323

7. Fm6a2627a8

8. (6r)-6-[2-[ethyl-[[4-[2-(ethylamino)ethyl]phenyl]methyl]amino]-4-methoxyphenyl]-5,6,7,8-tetrahydronaphthalen-2-ol

9. (6r)-6-{2-[ethyl({4-[2-(ethylamino)ethyl]phenyl}methyl)amino]-4-methoxyphenyl}-5,6,7,8-tetrahydronaphthalen-2-ol

10. (2r)-2-(2-(ethyl-((4-(2-(ethylamino)ethyl)phenyl)methyl)amino)-4-methoxy-phenyl)tetralin-6-ol

11. (6r)-6-(2-(ethyl((4-(2- (ethylamino)ethyl)phenyl)methyl)amino)-4-methoxyphenyl)- 5,6,7,8-tetrahydronaphthalen-2-ol

12. 2-naphthalenol, 6-(2-(ethyl((4-(2-(ethylamino)ethyl)phenyl)methyl)amino)-4-methoxyphenyl)-5,6,7,8-tetrahydro-, (6r)-

13. Elacestrant (usan/inn)

14. Elacestrant [usan:inn]

15. Elacestrant [who-dd]

16. Schembl229431

17. Unii-fm6a2627a8

18. Chembl4297509

19. Bdbm349630

20. Dtxsid901045846

21. Glxc-26208

22. Ex-a5070

23. Us10208011, Compound Rad-

24. Mfcd30532693

25. Who 10247

26. Cs-6306

27. Db06374

28. Hy-19822

29. D11671

30. Q27278069

31. (r)-6-(2-(ethyl(4-(2-(ethylamino)ethyl)benzyl)amino)-4-methoxyphenyl)-5,6,7,8-tetrahydronaphthalen-2-ol

32. I0v

2.4 Create Date
2008-01-14
3 Chemical and Physical Properties
Molecular Weight 458.6 g/mol
Molecular Formula C30H38N2O2
XLogP36.3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count10
Exact Mass458.293328459 g/mol
Monoisotopic Mass458.293328459 g/mol
Topological Polar Surface Area44.7 Ų
Heavy Atom Count34
Formal Charge0
Complexity578
Isotope Atom Count0
Defined Atom Stereocenter Count1
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 menopause and female hormonal deficiencies/abnormalities.


5 Pharmacology and Biochemistry
5.1 Mechanism of Action

RAD1901 is a novel selective estrogen receptor modulator(SERM). SERMs are small molecules that bind to and selectively modulate estrogen receptors. These molecules have the ability to stimulate or block estrogen's activity in different types of tissue, functioning as estrogen receptor agonists in some tissues and as estrogen receptor antagonists in others. RAD1901 has potential to reduce vasomotor symptoms, along with a simultaneous bone-protective effect, without stimulating breast or uterine tissues. RAD1901 is distinctive from other SERMs in its unique biological profile, combined with its significant ability to penetrate the blood-brain barrier, which enables RAD1901 to function as an estrogen agonist within the central nervous system and thereby relieve hot flashes.


Listed Suppliers

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Elacestrant

About the Company : Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the ...

Granules is a fast-growing, vertically integrated pharma company based in Hyderabad, committed to operational excellence, quality, and customer service. It manufactures across the entire value chain- APIs, Formulation Intermediates, & Formulations. With 11 facilities (8 in India, 2 in the US and 1 in Europe) approved by US FDA, EDQM, EU GMP, WHO GMP, & more, its products reach 300+ customers in 80+ countries. Granules has offices in India, the US, & Europe ensuring a strong global presence. Products listed herein may not be available for commercial use in countries where any relevant third-party intellectual property is in force.
Granules India

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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Elacestrant

About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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Apicore

India
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Apicore

India
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Elacestrant

About the Company : Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide p...

Apicore LLC, a wholly owned subsidiary of RK Pharma Inc is a leading process R&D and API manufacturing service provider for the worldwide pharmaceutical industry. We offer a wide portfolio of services ranging from API’s for the generic industry to custom synthesis for early phase pharmaceutical research and branded products. Our USFDA approved facilities in India (Visakhapatnam, Andhra Pradesh and Vadodara, Gujarat) are both equipped with state-of-the-art analytical and research capabilities. While our worldwide network of locations seamlessly integrate with each other, each unit also independently houses a full
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Apino Pharma

China
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Apino Pharma

China
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Elacestrant

About the Company : Apino Pharma prides itself on being an innovation-driven company that strives to continuously improve its products and services. Our dedicated innovation team collaborates with the...

Apino Pharma prides itself on being an innovation-driven company that strives to continuously improve its products and services. Our dedicated innovation team collaborates with the world’s leading research institutes and universities to develop cutting-edge formulations and technologies that bring value to our customers. We are committed to exploring new opportunities presented by technology, science and global best practices to provide quality products and services that meet and exceed our customers’ needs.
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Elacestrant

About the Company : Consistent growth and sustainability is a multidimensional aspiration for all at Macleods, we remained focused on providing quality and affordable medicines to billions of ailing p...

Consistent growth and sustainability is a multidimensional aspiration for all at Macleods, we remained focused on providing quality and affordable medicines to billions of ailing patients across geographies and bridging the gap of unmet needs of medical fraternity through continuous innovation. Our basic business philosophy, by its very nature, serves a social responsibility hence we have a far better reason than profits alone to drive our performance. Sustainability, is not a trend we blindly follow, it is intrinsic to how we have operated since the genesis of the organization in the year 1986.
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Elacestrant

About the Company : Sichuan Taienkang Pharmaceutical Co., Ltd., established in 2020, is a subsidiary of Guangdong Taienkang Pharmaceutical Co., Ltd. The company specializes in the R&D, production, and...

Sichuan Taienkang Pharmaceutical Co., Ltd., established in 2020, is a subsidiary of Guangdong Taienkang Pharmaceutical Co., Ltd. The company specializes in the R&D, production, and sales of generic APIs and intermediates, focusing on high-value APIs such as Dapoxetine Hydrochloride, Tadalafil, and others to meet diverse market needs. Located in the Yuechi Economic Development Zone, Sichuan Province, the manufacturing site spans 100 acres within a provincial-level chemical industry park. Phase one includes 4 independent production lines and a Class D GMP workshop, equipped with 500L to 5000L multifunctional reactors.
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API Reference Price

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30-Oct-2024
04-Jul-2025
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FDF Dossiers

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ELACESTRANT HYDROCHLORIDE

Brand Name : ORSERDU

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 86MG BASE

Packaging :

Approval Date : 2023-01-27

Application Number : 217639

Regulatory Info : RX

Registration Country : USA

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ELACESTRANT HYDROCHLORIDE

Brand Name : ORSERDU

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 345MG BASE

Packaging :

Approval Date : 2023-01-27

Application Number : 217639

Regulatory Info : RX

Registration Country : USA

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FDA Orange Book

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ELACESTRANT HYDROCHLORIDE

Brand Name : ORSERDU

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 86MG BASE

Approval Date : 2023-01-27

Application Number : 217639

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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ELACESTRANT HYDROCHLORIDE

Brand Name : ORSERDU

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 345MG BASE

Approval Date : 2023-01-27

Application Number : 217639

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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DATA COMPILATION #PharmaFlow

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DMF filings surge 44% in Q1 2025; India tops list with 51% rise in year-on-year submissions
The first quarter (Q1) of 2025 witnessed an impressive surge in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA), signaling a robust expansion in pharmaceutical development activities, the looming threat of tariffs notwithstanding.A total of 339 Type II DMFs were submitted during this period, as opposed to 235 submissions in Q1 2024, marking an exceptional increase of 44.26 percent. PharmaCompass’ data suggests that this is a record high for any first quarter.Overall, 440 DMFs were submitted across all categories (Types II, III, IV, and V) during Q1 2025, compared to 353 in the same period last year — representing a 24.65 percent increase.India and China continued to dominate the DMF landscape. India led with 162 submissions in Q1 2025, posting a remarkable 51.4 percent increase over 107 submissions recorded in Q1 2024. China followed with 135 submissions, representing a 33.66 percent increase over the 101 filings in Q1 2024.Taiwan sprung a surprise as a distant third. It made 12 DMF submissions in Q1 2025, as opposed to just one in Q1 2024. Western countries like the US, Spain, Germany, and Italy have maintained relatively stable or declining submission rates. Only the Netherlands showed significant growth with four DMF submissions in Q1 2025, up from zero in Q1 2024. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available)Indian giants MSN, Aurobindo, Cipla, Dr Reddy’s lead record-breaking DMF surgeIndia lived up to its “pharmacy of the world” reputation with the highest DMF submissions. In fact, seven of the top eight companies in the DMF tally were headquartered in India. MSN Group, emerged as the unequivocal leader with 23 submissions in Q1 2025, as against 15 in Q1 2024. Aurobindo Pharma increased its DMF activity from seven submissions in Q1 2024 to 12 in Q1 2025. Alivus Life Sciences, formerly known as Glenmark, made a dramatic leap with eight submissions in Q1 2025, quadrupling its previous year’s count of just two. Cipla more than doubled its DMF submissions — from three in Q1 2024 to eight in Q1 2025.Dr. Reddy’s Laboratories, one of India’s largest generic drugmakers, filed seven DMF submissions. The company’s Q1 2025 DMF portfolio includes high-value molecules like deucravacitinib, finerenone, enzalutamide, niraparib tosylate monohydrate, tucatinib, and tizanidine hydrochloride.Dr. Reddy’s has also indicated that they are open to manufacturing in the US. Meanwhile, Hetero Drugs filed seven submissions while Lee Pharma recorded six in Q1 2025.Chinese manufacturer Jiangsu East-Mab Biomedical Technology also established a significant presence with six DMFs. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Semaglutide, finerenone see most DMF submissions; first-time filings surge 64%Semaglutide and finerenone emerged as the most documented molecules in Q1 2025, each garnering nine DMF submissions. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist that has revolutionized diabetes management and weight loss treatment, continues to attract significant manufacturer interest. Similarly, finerenone, a non-steroidal drug used in treating chronic kidney disease in type 2 diabetes patients, has garnered attention from manufacturers.Carfilzomib, used in multiple myeloma treatment, secured the third position with five DMF submissions. Deucravacitinib, a novel drug approved for moderate to severe plaque psoriasis, followed with four DMF submissions.There were several molecules with three DMF submissions each. Among them were tapinarof, a novel drug for psoriasis, and tirzepatide, a GLP-1/GIP receptor agonist that has shown remarkable efficacy in diabetes and weight management. During the quarter, 23 molecules received their inaugural DMF submissions. This number has risen by 64 percent since Q1 2024, when only 14 drugs saw their first DMF filings.In Q1 2025, these 23 first-time molecules collectively garnered 30 DMF submissions, with deucravacitinib emerging as the clear leader. Indian companies Dr. Reddy’s Laboratories and Cipla filed DMFs for this plaque psoriasis treatment as did Spain’s Curia and PMC Global.The Q1 2025 roster of first-time DMF filings include retatrutide (another GLP-1 receptor agonist), sotagliflozin, setmelanotide acetate, daridorexant, nusinersen, zavegepant, belzutifan, elacestrant dihydrochloride, selumetinib sulfate, sotorasib, atogepant, omadacycline tosylate, osilodrostat phosphate, ensifentrine, landiolol hydrochloride, maralixibat chloride, maribavir, methyl olivetolate, diazoxide choline, sparsentan, thinnertide, and vismodegib. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Our viewGiven Trump’s rhetoric around tariffs on imported drugs, the record-breaking DMF submissions in Q1 2025 sent out a strong message that the global pharmaceutical industry is willing to take on the complex geopolitical situation with resilience and strategic foresight.On a different note, the rise in DMF filings also indicate increased workload for the FDA staff, as also more inspections by the agency. It seems like more ‘laid off’ FDA employees will be asked to return to work in the coming days.

Impressions: 2198

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-surge-44-in-q1-2025-india-tops-list-with-51-rise-in-year-on-year-submissions

#PharmaFlow by PHARMACOMPASS
15 May 2025

NEWS #PharmaBuzz

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Looking for 722533-56-4 / Elacestrant API manufacturers, exporters & distributors?

Elacestrant manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Elacestrant

Synonyms

722533-56-4, Rad1901, Elacestrant [inn], Elacestrant [usan], Rad-1901, Er-306323

Cas Number

722533-56-4

Unique Ingredient Identifier (UNII)

FM6A2627A8

About Elacestrant

Elacestrant is an orally available, selective estrogen receptor degrader (SERD) and selective estrogen receptor modulator (SERM), with potential antineoplastic and estrogen-like activities. Upon oral administration of higher doses of elacestrant, this agent acts as a SERD, which binds to the estrogen receptor (ER) and induces a conformational change that results in the degradation of the receptor. This may inhibit the growth and survival of ER-expressing cancer cells. At lower doses of this agent, RAD1901 acts as a SERM and has estrogen-like effects in certain tissues, which can both reduce hot flashes and protect against bone loss. In addition, elacestrant is able to cross the blood-brain barrier (BBB).

Elacestrant Manufacturers

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

Elacestrant Suppliers

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

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

Elacestrant USDMF

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

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

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

Elacestrant GMP

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

Elacestrant CoA

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

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

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