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Chemistry

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Also known as: 1350636-82-6, Bc-3781 acetate, Acetic acid;[(1s,2r,3s,4s,6r,7r,8r,14r)-4-ethenyl-3-hydroxy-2,4,7,14-tetramethyl-9-oxo-6-tricyclo[5.4.3.01,8]tetradecanyl] 2-[(1r,2r,4r)-4-amino-2-hydroxycyclohexyl]sulfanylacetate, Bc-3781.ac, Lefamulinacetate, Xenleta (tn)
Molecular Formula
C30H49NO7S
Molecular Weight
567.8  g/mol
InChI Key
WSMXIQXWHPSVDE-ZPJPNJFZSA-N

Lefamulin Acetate
1 2D Structure

Lefamulin Acetate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
acetic acid;[(1S,2R,3S,4S,6R,7R,8R,14R)-4-ethenyl-3-hydroxy-2,4,7,14-tetramethyl-9-oxo-6-tricyclo[5.4.3.01,8]tetradecanyl] 2-[(1R,2R,4R)-4-amino-2-hydroxycyclohexyl]sulfanylacetate
2.1.2 InChI
InChI=1S/C28H45NO5S.C2H4O2/c1-6-26(4)14-22(34-23(32)15-35-21-8-7-18(29)13-20(21)31)27(5)16(2)9-11-28(17(3)25(26)33)12-10-19(30)24(27)28;1-2(3)4/h6,16-18,20-22,24-25,31,33H,1,7-15,29H2,2-5H3;1H3,(H,3,4)/t16-,17+,18-,20-,21-,22-,24+,25+,26-,27+,28+;/m1./s1
2.1.3 InChI Key
WSMXIQXWHPSVDE-ZPJPNJFZSA-N
2.1.4 Canonical SMILES
CC1CCC23CCC(=O)C2C1(C(CC(C(C3C)O)(C)C=C)OC(=O)CSC4CCC(CC4O)N)C.CC(=O)O
2.1.5 Isomeric SMILES
C[C@@H]1CC[C@@]23CCC(=O)[C@H]2[C@@]1([C@@H](C[C@@]([C@H]([C@@H]3C)O)(C)C=C)OC(=O)CS[C@@H]4CC[C@H](C[C@H]4O)N)C.CC(=O)O
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. 1350636-82-6

2. Bc-3781 Acetate

3. Acetic Acid;[(1s,2r,3s,4s,6r,7r,8r,14r)-4-ethenyl-3-hydroxy-2,4,7,14-tetramethyl-9-oxo-6-tricyclo[5.4.3.01,8]tetradecanyl] 2-[(1r,2r,4r)-4-amino-2-hydroxycyclohexyl]sulfanylacetate

4. Bc-3781.ac

5. Lefamulinacetate

6. Xenleta (tn)

7. Lefamulin Acetate (xenleta)

8. Chembl3545309

9. Dtxsid801027897

10. S3496

11. At18250

12. D11632

13. Q27279882

2.3 Create Date
2015-01-12
3 Chemical and Physical Properties
Molecular Weight 567.8 g/mol
Molecular Formula C30H49NO7S
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count9
Rotatable Bond Count6
Exact Mass567.32297408 g/mol
Monoisotopic Mass567.32297408 g/mol
Topological Polar Surface Area172 Ų
Heavy Atom Count39
Formal Charge0
Complexity882
Isotope Atom Count0
Defined Atom Stereocenter Count11
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Xenleta is indicated for the treatment of community-acquired pneumonia (CAP) in adults when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of CAP or when these have failed.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.


5 Pharmacology and Biochemistry
5.1 ATC Code

J01XX


Listed Suppliers

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01

Chemicals America
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Chemicals America
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Lefamulin Acetate

About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...

Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients and their intermediates, electronic chemical materials and intermediates, large-scale production, sales and services, and provide customized synthetic services according to customer requirements. Sjar-Tech locates in Beijing Economic and Technological Development Zone, has its own R&D and development laboratory. Sjar-Tech has set up a R&D team with rich experience and strong technical strength, most of the practitioners have more than ten years' experience.
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Chemicals America
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Chemicals America
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Lefamulin Acetate

About the Company : Glixx Laboratories Inc (Glixx) is a global leading company specializing in biological research chemicals, providing services to meet the needs of biomedical research markets. With ...

Glixx Laboratories Inc (Glixx) is a global leading company specializing in biological research chemicals, providing services to meet the needs of biomedical research markets. With its fast and efficient synthesis, the Glixx R&D team focuses on commercializing newly discovered research chemicals and bringing them to the life sciences R&D communities. Our company goal is to help our community by lowering the cost of the essential chemicals for research needs, to better progress on to new discoveries in drug development, medical screening, and all facets of scientific innovations.
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03

J&H CHEM

China
Chemicals America
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J&H CHEM

China
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Chemicals America
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Lefamulin Acetate

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...

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 Value-added customer services, for diversified range products of chemicals, pharmaceuticals, and specialities. As a highly customer-oriented enterprise, we always believe "Customer first, service foremost", put forward innovation, continuously improve pipeline, integrate our broad range of products and services with our technical expertise, customise a competitive package to meet our customers' specific needs.
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04

Chemicals America
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Chemicals America
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Lefamulin Acetate

About the Company : Sun-shine chemical has over 1,500m² of operation premises. The R&D laboratory is more than 1,000m² and is equipped with a variety of R&D laboratory equipment. The quality control...

Sun-shine chemical has over 1,500m² of operation premises. The R&D laboratory is more than 1,000m² and is equipped with a variety of R&D laboratory equipment. The quality control management laboratory is over 200m², equipped with high-efficient liquid chromatograph, digital melting point apparatus, digital polarimeter, UV spectrophotometer, etc. We have set up one kilogram-level intermediate laboratories, which may ensure growing customer demand and smooth commercial production. Sun-shine chemical is a reliable world supplier in fine chemicals and custom manufacturing.
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Drugs in Development

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Details:

Meitheal secured commercial rights in the U.S. to Xenleta (lefamulin acetate) through an exclusive license agreement with its parent company. It is indicated for the CABP in adults.


Lead Product(s): Lefamulin Acetate

Therapeutic Area: Infections and Infectious Diseases Brand Name: Xenleta

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Meitheal Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement December 11, 2024

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01

Chemicals America
Not Confirmed
Chemicals America
Not Confirmed

Details : Meitheal secured commercial rights in the U.S. to Xenleta (lefamulin acetate) through an exclusive license agreement with its parent company. It is indicated for the CABP in adults.

Product Name : Xenleta

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

December 11, 2024

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Details:

XENLETA (lefamulin) is first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow.


Lead Product(s): Lefamulin Acetate

Therapeutic Area: Genetic Disease Brand Name: Xenleta

Study Phase: Phase IProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 28, 2022

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02

Chemicals America
Not Confirmed
Chemicals America
Not Confirmed

Details : XENLETA (lefamulin) is first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required...

Product Name : Xenleta

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 28, 2022

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Details:

Xenleta (lefamulin) is a novel, first-in-class, IV and oral pleuromutilin antimicrobial agent that has been demonstrated to be highly potent against S. aureus, including MRSA and strains obtained from patients with CF.


Lead Product(s): Lefamulin Acetate

Therapeutic Area: Genetic Disease Brand Name: Xenleta

Study Phase: Phase IProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 08, 2022

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03

Chemicals America
Not Confirmed
Chemicals America
Not Confirmed

Details : Xenleta (lefamulin) is a novel, first-in-class, IV and oral pleuromutilin antimicrobial agent that has been demonstrated to be highly potent against S. aureus, including MRSA and strains obtained from patients with CF.

Product Name : Xenleta

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 08, 2022

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Details:

XENLETA has the potential to provide a well-tolerated oral and intravenous anti-MRSA treatment option with a novel mechanism for this difficult to treat patient population. We look forward to sharing the results of this study with the medical community.


Lead Product(s): Lefamulin Acetate

Therapeutic Area: Genetic Disease Brand Name: Xenleta

Study Phase: Phase IProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 04, 2022

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04

Chemicals America
Not Confirmed
Chemicals America
Not Confirmed

Details : XENLETA has the potential to provide a well-tolerated oral and intravenous anti-MRSA treatment option with a novel mechanism for this difficult to treat patient population. We look forward to sharing the results of this study with the medical community.

Product Name : Xenleta

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 04, 2022

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Details:

Under the terms of the agreement, Er-Kim gains exclusive rights to distribute XENLETA (lefamulin) in the following countries: Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Slovakia, and Slovenia.


Lead Product(s): Lefamulin Acetate

Therapeutic Area: Infections and Infectious Diseases Brand Name: Xenleta

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Erkim

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 18, 2022

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05

Chemicals America
Not Confirmed
Chemicals America
Not Confirmed

Details : Under the terms of the agreement, Er-Kim gains exclusive rights to distribute XENLETA (lefamulin) in the following countries: Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Slovakia, and Slovenia.

Product Name : Xenleta

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

July 18, 2022

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Details:

Sumitomo filed NDA to market oral and IV formulations of lefamulin,first systemic pleuromutilin antibiotic for the treatment of community-acquired pneumonia in adults in mainland China.


Lead Product(s): Lefamulin Acetate

Therapeutic Area: Infections and Infectious Diseases Brand Name: Xenleta

Study Phase: IND EnablingProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 29, 2021

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06

Chemicals America
Not Confirmed
Chemicals America
Not Confirmed

Details : Sumitomo filed NDA to market oral and IV formulations of lefamulin,first systemic pleuromutilin antibiotic for the treatment of community-acquired pneumonia in adults in mainland China.

Product Name : Xenleta

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 29, 2021

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Details:

XENLETA® (lefamulin) is first-in-class pleuromutilin antibiotic for treatment of community-acquired bacterial pneumonia (CABP). It's in vitro activity of lefamulin against Staphylococcus aureus isolated from lower respiratory tract of children with cystic fibrosis.


Lead Product(s): Lefamulin Acetate

Therapeutic Area: Genetic Disease Brand Name: Xenleta

Study Phase: PreclinicalProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 24, 2021

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07

Chemicals America
Not Confirmed
Chemicals America
Not Confirmed

Details : XENLETA® (lefamulin) is first-in-class pleuromutilin antibiotic for treatment of community-acquired bacterial pneumonia (CABP). It's in vitro activity of lefamulin against Staphylococcus aureus isolated from lower respiratory tract of children with cyst...

Product Name : Xenleta

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 24, 2021

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Details:

Sinovant’s multi-center, randomized, double-blind trial was designed to evaluate the safety and efficacy of intravenous (IV) to oral lefamulin compared to IV/oral moxifloxacin in 125 subjects with CABP.


Lead Product(s): Lefamulin Acetate

Therapeutic Area: Infections and Infectious Diseases Brand Name: Xenleta

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Nabriva Therapeutics

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 25, 2021

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08

Chemicals America
Not Confirmed
Chemicals America
Not Confirmed

Details : Sinovant’s multi-center, randomized, double-blind trial was designed to evaluate the safety and efficacy of intravenous (IV) to oral lefamulin compared to IV/oral moxifloxacin in 125 subjects with CABP.

Product Name : Xenleta

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 25, 2021

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Details:

XENLETA is the first intravenous and oral pleuromutilin approved for the systemic treatment of community acquired bacterial pneumonia (CABP) in adults, and also reduced pro-inflammatory cytokines comparable to that observed with dexamethasone.


Lead Product(s): Lefamulin Acetate

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Xenleta

Study Phase: PreclinicalProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 10, 2021

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09

Chemicals America
Not Confirmed
Chemicals America
Not Confirmed

Details : XENLETA is the first intravenous and oral pleuromutilin approved for the systemic treatment of community acquired bacterial pneumonia (CABP) in adults, and also reduced pro-inflammatory cytokines comparable to that observed with dexamethasone.

Product Name : Xenleta

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 10, 2021

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Details:

Findings underscore potential of XENLETA as a first-in-class pleuromutilin antibiotic for the IV and oral treatment of CABP in adults, including older patients with comorbidities who are at risk of poor outcomes


Lead Product(s): Lefamulin Acetate

Therapeutic Area: Infections and Infectious Diseases Brand Name: Xenleta

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 13, 2020

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10

Chemicals America
Not Confirmed
Chemicals America
Not Confirmed

Details : Findings underscore potential of XENLETA as a first-in-class pleuromutilin antibiotic for the IV and oral treatment of CABP in adults, including older patients with comorbidities who are at risk of poor outcomes

Product Name : Xenleta

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 13, 2020

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Looking for 1350636-82-6 / Lefamulin Acetate API manufacturers, exporters & distributors?

Lefamulin Acetate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Lefamulin Acetate

Synonyms

1350636-82-6, Bc-3781 acetate, Acetic acid;[(1s,2r,3s,4s,6r,7r,8r,14r)-4-ethenyl-3-hydroxy-2,4,7,14-tetramethyl-9-oxo-6-tricyclo[5.4.3.01,8]tetradecanyl] 2-[(1r,2r,4r)-4-amino-2-hydroxycyclohexyl]sulfanylacetate, Bc-3781.ac, Lefamulinacetate, Xenleta (tn)

Cas Number

1350636-82-6

Lefamulin Acetate Manufacturers

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

Lefamulin Acetate Suppliers

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

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

Lefamulin Acetate GMP

Lefamulin Acetate 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 Lefamulin Acetate 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 Lefamulin Acetate GMP manufacturer or Lefamulin Acetate GMP API supplier for your needs.

Lefamulin Acetate CoA

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

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

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