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Chemistry

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Also known as:
Molecular Formula
C5H4N4O
Molecular Weight
136.11  g/mol
InChI Key
OFCNXPDARWKPPY-UHFFFAOYSA-N

Allopurinol
1 2D Structure

Allopurinol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1,2-dihydropyrazolo[3,4-d]pyrimidin-4-one
2.1.2 InChI
InChI=1S/C5H4N4O/c10-5-3-1-8-9-4(3)6-2-7-5/h1-2H,(H2,6,7,8,9,10)
2.1.3 InChI Key
OFCNXPDARWKPPY-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=C2C(=NC=NC2=O)NN1
2.1.5 Isomeric SMILES
C1=C2C(=NC=NC2=O)NN1
2.2 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 136.11 g/mol
Molecular Formula C5H4N4O
XLogP3-0.5
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count2
Rotatable Bond Count0
Exact Mass136.03851076 g/mol
Monoisotopic Mass136.03851076 g/mol
Topological Polar Surface Area65.8 A^2
Heavy Atom Count10
Formal Charge0
Complexity275
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 10  
Drug NameAllopurinol
PubMed HealthAllopurinol
Drug ClassesAntigout, Urinary Stone Agent
Drug LabelAllopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d ]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37C is 80 mg/dL and is greater in an alkaline solution. Allopurinol Table...
Active IngredientAllopurinol
Dosage FormTablet
RouteOral
Strength300mg; 100mg
Market StatusPrescription
CompanyWatson Labs; Vintage Pharms; Ipca Labs; Mutual Pharm; Apotex; Accord Hlthcare; Sun Pharm Inds; Northstar Hlthcare; Mylan

2 of 10  
Drug NameAllopurinol sodium
PubMed HealthAllopurinol (Injection)
Drug ClassesAntigout, Urinary Stone Agent
Drug LabelALOPRIM (allopurinol sodium) for Injection is the brand name for allopurinol, a xanthine oxidase inhibitor. ALOPRIM (allopurinol sodium) for Injection is a sterile solution for intravenous infusion only. It is available in vials as the sterile lyophi...
Active IngredientAllopurinol sodium
Dosage FormInjectable
RouteInjection
Strengtheq 500mg base/vial
Market StatusPrescription
CompanyEurohlth Intl

3 of 10  
Drug NameAloprim
PubMed HealthAllopurinol
Drug ClassesAntigout, Urinary Stone Agent
Drug LabelZYLOPRIM (allopurinol) has the following structural formula:ZYLOPRIM is known chemically as 1,5-dihydro-4H-pyrazolo [3,4-d]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Each scored white tablet contains 100 mg allo...
Active IngredientAllopurinol sodium
Dosage FormInjectable
RouteInjection
Strengtheq 500mg base/vial
Market StatusPrescription
CompanyMylan Institutional

4 of 10  
Drug NameLopurin
Active IngredientAllopurinol
Dosage FormTablet
RouteOral
Strength300mg; 100mg
Market StatusPrescription
CompanyDr Reddys La

5 of 10  
Drug NameZyloprim
Active IngredientAllopurinol
Dosage FormTablet
RouteOral
Strength300mg; 100mg
Market StatusPrescription
CompanyPrometheus Labs

6 of 10  
Drug NameAllopurinol
PubMed HealthAllopurinol
Drug ClassesAntigout, Urinary Stone Agent
Drug LabelAllopurinol is known chemically as 1,5-Dihydro-4H-pyrazolo[3,4-d ]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Its solubility in water at 37C is 80 mg/dL and is greater in an alkaline solution. Allopurinol Table...
Active IngredientAllopurinol
Dosage FormTablet
RouteOral
Strength300mg; 100mg
Market StatusPrescription
CompanyWatson Labs; Vintage Pharms; Ipca Labs; Mutual Pharm; Apotex; Accord Hlthcare; Sun Pharm Inds; Northstar Hlthcare; Mylan

7 of 10  
Drug NameAllopurinol sodium
PubMed HealthAllopurinol (Injection)
Drug ClassesAntigout, Urinary Stone Agent
Drug LabelALOPRIM (allopurinol sodium) for Injection is the brand name for allopurinol, a xanthine oxidase inhibitor. ALOPRIM (allopurinol sodium) for Injection is a sterile solution for intravenous infusion only. It is available in vials as the sterile lyophi...
Active IngredientAllopurinol sodium
Dosage FormInjectable
RouteInjection
Strengtheq 500mg base/vial
Market StatusPrescription
CompanyEurohlth Intl

8 of 10  
Drug NameAloprim
PubMed HealthAllopurinol
Drug ClassesAntigout, Urinary Stone Agent
Drug LabelZYLOPRIM (allopurinol) has the following structural formula:ZYLOPRIM is known chemically as 1,5-dihydro-4H-pyrazolo [3,4-d]pyrimidin-4-one. It is a xanthine oxidase inhibitor which is administered orally. Each scored white tablet contains 100 mg allo...
Active IngredientAllopurinol sodium
Dosage FormInjectable
RouteInjection
Strengtheq 500mg base/vial
Market StatusPrescription
CompanyMylan Institutional

9 of 10  
Drug NameLopurin
Active IngredientAllopurinol
Dosage FormTablet
RouteOral
Strength300mg; 100mg
Market StatusPrescription
CompanyDr Reddys La

10 of 10  
Drug NameZyloprim
Active IngredientAllopurinol
Dosage FormTablet
RouteOral
Strength300mg; 100mg
Market StatusPrescription
CompanyPrometheus Labs

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CEP/COS

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  • fda
  • EDQM
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Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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CEP 2023-029 - Rev 00
Valid
Chemical
2024-06-10
576
IOL Chemicals

01

  • fda
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  • WHO-GMP

Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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Certificate Number : CEP 2023-029 - Rev 00

Status : Valid

Issue Date : 2024-06-10

Type : Chemical

Substance Number : 576

IOL Chemicals
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Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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CEP 2014-364 - Rev 01
Valid
Chemical
2023-11-27
576
Egis Pharmaceuticals

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Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Digital Content Digital Content

Certificate Number : CEP 2014-364 - Rev 01

Status : Valid

Issue Date : 2023-11-27

Type : Chemical

Substance Number : 576

Egis Pharmaceuticals
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  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Digital Content Digital Content
R1-CEP 1996-032 - Rev 05
Valid
Chemical
2019-08-09
576
Egis Pharmaceuticals

03

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  • EDQM
  • WHO-GMP

Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Certificate Number : R1-CEP 1996-032 - Rev 05

Status : Valid

Issue Date : 2019-08-09

Type : Chemical

Substance Number : 576

Egis Pharmaceuticals
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  • WHO-GMP

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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CEP 1998-118 - Rev 08
Valid
Chemical
2025-07-11
576
TAPI Company Banner

04

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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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Certificate Number : CEP 1998-118 - Rev 08

Status : Valid

Issue Date : 2025-07-11

Type : Chemical

Substance Number : 576

TAPI Company Banner
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  • WHO-GMP

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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Digital Content Digital Content
CEP 2014-117 - Rev 03
Valid
Chemical
2025-06-30
576
TAPI Company Banner

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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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Certificate Number : CEP 2014-117 - Rev 03

Status : Valid

Issue Date : 2025-06-30

Type : Chemical

Substance Number : 576

TAPI Company Banner
  • fda
  • EDQM
  • WHO-GMP

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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CEP 1999-007 - Rev 08
Valid
Chemical
2025-04-01
576
TAPI Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

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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Certificate Number : CEP 1999-007 - Rev 08

Status : Valid

Issue Date : 2025-04-01

Type : Chemical

Substance Number : 576

TAPI Company Banner

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Certificate Number : R0-CEP 2007-189 - Rev 00

Status : Expired

Issue Date : 2010-06-30

Type : Chemical

Substance Number : 576

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AIChE Annual Meeting
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Certificate Number : R0-CEP 2003-213 - Rev 00

Status : Withdrawn by Holder

Issue Date : 2004-10-13

Type : Chemical

Substance Number : 576

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Certificate Number : R0-CEP 2004-189 - Rev 02

Status : Withdrawn by EDQM Failure to CEP pro...

Issue Date : 2008-09-26

Type : Chemical

Substance Number : 576

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API Reference Price

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Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663093800,"product":"ALLOPURINOL USP API","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"ENDO VENTURES LTD","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"399.66","actualQuantity":"399.66","unit":"KGS","unitRateFc":"55","totalValueFC":"22122.6","currency":"USD","unitRateINR":"4436.1","date":"14-Sep-2022","totalValueINR":"1772925.32","totalValueInUsd":"22122.6","indian_port":"MADRAS SEA","hs_no":"29335990","bill_no":"2441126","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663093800,"product":"ALLOPURINOL USP API","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"ENDO VENTURES LTD","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"599.62","actualQuantity":"599.622","unit":"KGS","unitRateFc":"55","totalValueFC":"33190.6","currency":"USD","unitRateINR":"4436","date":"14-Sep-2022","totalValueINR":"2659928.91","totalValueInUsd":"33190.6","indian_port":"MADRAS SEA","hs_no":"29335990","bill_no":"2441586","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663093800,"product":"ALLOPURINOL USP API","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"ENDO VENTURES LTD","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"599.63","actualQuantity":"599.634","unit":"KGS","unitRateFc":"55","totalValueFC":"33191.8","currency":"USD","unitRateINR":"4436.1","date":"14-Sep-2022","totalValueINR":"2660026.78","totalValueInUsd":"33191.8","indian_port":"MADRAS SEA","hs_no":"29335990","bill_no":"2441126","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663093800,"product":"ALLOPURINOL USP API","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"ENDO VENTURES LTD","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"599.65","actualQuantity":"599.646","unit":"KGS","unitRateFc":"55","totalValueFC":"33191.9","currency":"USD","unitRateINR":"4436","date":"14-Sep-2022","totalValueINR":"2660035.37","totalValueInUsd":"33191.9","indian_port":"MADRAS SEA","hs_no":"29335990","bill_no":"2441586","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663093800,"product":"ALLOPURINOL USP API","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"ENDO VENTURES LTD","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"599.65","actualQuantity":"599.646","unit":"KGS","unitRateFc":"55","totalValueFC":"33192.5","currency":"USD","unitRateINR":"4436.1","date":"14-Sep-2022","totalValueINR":"2660080.01","totalValueInUsd":"33192.5","indian_port":"MADRAS SEA","hs_no":"29335990","bill_no":"2441126","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663093800,"product":"ALLOPURINOL USP API","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"ENDO VENTURES LTD","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"599.65","actualQuantity":"599.652","unit":"KGS","unitRateFc":"55","totalValueFC":"33192.3","currency":"USD","unitRateINR":"4436","date":"14-Sep-2022","totalValueINR":"2660061.99","totalValueInUsd":"33192.3","indian_port":"MADRAS SEA","hs_no":"29335990","bill_no":"2441586","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663093800,"product":"ALLOPURINOL USP API","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"ENDO VENTURES LTD","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"599.66","actualQuantity":"599.658","unit":"KGS","unitRateFc":"55","totalValueFC":"33193.1","currency":"USD","unitRateINR":"4436.1","date":"14-Sep-2022","totalValueINR":"2660133.24","totalValueInUsd":"33193.1","indian_port":"MADRAS SEA","hs_no":"29335990","bill_no":"2441126","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663093800,"product":"ALLOPURINOL USP API","address":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam","city":"Kelambakkam","supplier":"ENDO VENTURES LTD","supplierCountry":"UNITED STATES","foreign_port":"NA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"599.67","actualQuantity":"599.67","unit":"KGS","unitRateFc":"55","totalValueFC":"33193.2","currency":"USD","unitRateINR":"4436","date":"14-Sep-2022","totalValueINR":"2660141.84","totalValueInUsd":"33193.2","indian_port":"MADRAS SEA","hs_no":"29335990","bill_no":"2441586","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"No. 9\/215, Pudupakkam - Vandalur Main Road Pudupakkam"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1684261800,"product":"ALLOPURINOL EP","address":"107A, VINAY BHAVYA COMPLEX 159, A, C.S.T ROAD, KALINA SANTACRUZ(E","city":"MUMBAI","supplier":"GLAXOSMITHKLINE EGYPT","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"HARMAN FINOCHEM LTD","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"800","totalValueFC":"194.5","currency":"USD","unitRateINR":"80039.4","date":"17-May-2023","totalValueINR":"16007.88","totalValueInUsd":"194.5","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"India","selfForZScoreResived":"Pharma Grade","supplierPort":"CAIRO","supplierAddress":"","customerAddress":"107A, VINAY BHAVYA COMPLEX 159, A, C.S.T ROAD, KALINA SANTACRUZ(E"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686249000,"product":"ALLOPURINOL MICRONIZED","address":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham","city":"HYDERABAD","supplier":"UNION QUIMICO FARMACEUTICASA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"900","totalValueFC":"1826.4","currency":"USD","unitRateINR":"75060","date":"09-Jun-2023","totalValueINR":"150119.928","totalValueInUsd":"1826.4","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Micronized","supplierPort":"NA","supplierAddress":"","customerAddress":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753468200,"product":"(RE-IMPORT REJECTED GOODS) ALLOPURINOL USP (RE-IMPORT REJECTED GOODS) ALLOPURINOL USP","address":"48, KANDIVLI INDUSTRIAL ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"POLIPHARM CO LTD","supplierCountry":"INDIA","foreign_port":"LAEM CHABANG","customer":"IPCA LABORATORIES LTD","customerCountry":"INDIA","quantity":"849.79","actualQuantity":"849.79","unit":"KGS","unitRateFc":"35","totalValueFC":"29991.7","currency":"USD","unitRateINR":"3037.5","date":"26-Jul-2025","totalValueINR":"2581262.26","totalValueInUsd":"29991.7","indian_port":"JNPT","hs_no":"29335990","bill_no":"3518576","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"109 SOI WAT BANG PHLI YAI NAI, MOO 12 BANG PHLI YAI, BANG PHLI SAMUT P RAKAN 10540 Samut Prakan, , Thailan Thailand","customerAddress":"48, KANDIVLI INDUSTRIAL ESTATE,"}]
01-Jan-2022
29-Sep-2025
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

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

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API Imports and Exports

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 100MG

USFDA APPLICATION NUMBER - 16084

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DOSAGE - TABLET;ORAL - 200MG

USFDA APPLICATION NUMBER - 16084

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DOSAGE - TABLET;ORAL - 300MG

USFDA APPLICATION NUMBER - 16084

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DOSAGE - TABLET;ORAL - 200MG;200MG

USFDA APPLICATION NUMBER - 209203

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DOSAGE - TABLET;ORAL - 300MG;200MG

USFDA APPLICATION NUMBER - 209203

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Related Excipient Companies

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Excipients by Applications

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Fillers, Diluents & Binders

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Coating Systems & Additives

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Disintegrants & Superdisintegrants

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Direct Compression

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Granulation

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Thickeners and Stabilizers

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Co-Processed Excipients

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Chewable & Orodispersible Aids

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Solubilizers

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Film Formers & Plasticizers

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Taste Masking

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API Stability Enhancers

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Vegetarian Capsules

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DATA COMPILATION #PharmaFlow

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NEWS #PharmaBuzz

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Global Sales Information

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Market Place

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APIs

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Patents & EXCLUSIVITIES

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US Patents

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01

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Florida Innovation
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Florida Innovation
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ALLOPURINOL; LESINURAD

US Patent Number : 8084483

Drug Substance Claim :

Drug Product Claim :

Application Number : 209203

Patent Use Code : U-2104

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-08-17

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02

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Florida Innovation
Not Confirmed
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Florida Innovation
Not Confirmed

ALLOPURINOL; LESINURAD

US Patent Number : 8546437

Drug Substance Claim :

Drug Product Claim :

Application Number : 209203

Patent Use Code : U-2104

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-04-29

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03

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Florida Innovation
Not Confirmed
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Florida Innovation
Not Confirmed

ALLOPURINOL; LESINURAD

US Patent Number : 8357713

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 209203

Patent Use Code : U-2104

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-12-22

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04

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Florida Innovation
Not Confirmed
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Florida Innovation
Not Confirmed

ALLOPURINOL; LESINURAD

US Patent Number : 9216179

Drug Substance Claim :

Drug Product Claim :

Application Number : 209203

Patent Use Code : U-2104

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-08-01

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05

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Florida Innovation
Not Confirmed
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Florida Innovation
Not Confirmed

ALLOPURINOL; LESINURAD

US Patent Number : 8546437

Drug Substance Claim :

Drug Product Claim :

Application Number : 209203

Patent Use Code : U-2104

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-04-29

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06

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Florida Innovation
Not Confirmed
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Florida Innovation
Not Confirmed

ALLOPURINOL; LESINURAD

US Patent Number : 10183012

Drug Substance Claim :

Drug Product Claim :

Application Number : 209203

Patent Use Code : U-2104

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-11-26

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07

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Florida Innovation
Not Confirmed
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Florida Innovation
Not Confirmed

ALLOPURINOL; LESINURAD

US Patent Number : 9956205

Drug Substance Claim :

Drug Product Claim :

Application Number : 209203

Patent Use Code : U-2104

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-12-28

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08

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Florida Innovation
Not Confirmed
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Florida Innovation
Not Confirmed

ALLOPURINOL; LESINURAD

US Patent Number : 9216179

Drug Substance Claim :

Drug Product Claim :

Application Number : 209203

Patent Use Code : U-2104

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-08-01

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09

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Florida Innovation
Not Confirmed
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Florida Innovation
Not Confirmed

ALLOPURINOL; LESINURAD

US Patent Number : 8003681

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 209203

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-08-25

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10

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Florida Innovation
Not Confirmed
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Florida Innovation
Not Confirmed

ALLOPURINOL; LESINURAD

US Patent Number : 8283369

Drug Substance Claim :

Drug Product Claim :

Application Number : 209203

Patent Use Code : U-2104

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-11-26

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REF. STANDARDS & IMPURITIES

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EDQM

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01

EDQM, Council of Europe

Allopurinol impurity E

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Florida Innovation
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01

Florida Innovation
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Allopurinol impurity E

CAS Number : N/A

Quantity Per Vial : 20 mg

Sale Unit : 1

Order Code : A0350050

Batch No : 1

Price (€) : 79

Storage : +5°C ± 3°C

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02

EDQM, Council of Europe

Allopurinol impurity D

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Florida Innovation
Not Confirmed

02

Florida Innovation
Not Confirmed

Allopurinol impurity D

CAS Number : 6994-25-8

Quantity Per Vial : 15 mg

Sale Unit : 1

Order Code : A0350040

Batch No : 4

Price (€) : 79

Storage : +5°C ± 3°C

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03

EDQM, Council of Europe

Allopurinol impurity C

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Florida Innovation
Not Confirmed

03

Florida Innovation
Not Confirmed

Allopurinol impurity C

CAS Number : N/A

Quantity Per Vial : 10 mg

Sale Unit : 1

Order Code : A0350030

Batch No : 3

Price (€) : 79

Storage : +5°C ± 3°C

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04

EDQM, Council of Europe

Allopurinol impurity B

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Florida Innovation
Not Confirmed

04

Florida Innovation
Not Confirmed

Allopurinol impurity B

CAS Number : 22407-20-1

Quantity Per Vial : 10 mg

Sale Unit : 1

Order Code : A0350020

Batch No : 4

Price (€) : 79

Storage : +5°C ± 3°C

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05

EDQM, Council of Europe

Allopurinol impurity A

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Florida Innovation
Not Confirmed

05

Florida Innovation
Not Confirmed

Allopurinol impurity A

CAS Number : 27511-79-1

Quantity Per Vial : 10 mg

Sale Unit : 1

Order Code : A0350010

Batch No : 3

Price (€) : 79

Storage : +5°C ± 3°C

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06

Florida Innovation
Not Confirmed

06

Florida Innovation
Not Confirmed

Allopurinol

CAS Number : 315-30-0

Quantity Per Vial : 100 mg

Sale Unit : 1

Order Code : A0350000

Batch No : 3

Price (€) : 79

Storage : +5°C ± 3°C

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ANALYTICAL

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Analytical Methods

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ABOUT THIS PAGE

Looking for / Allopurinol API manufacturers, exporters & distributors?

Allopurinol manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Allopurinol

Allopurinol Manufacturers

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

Allopurinol Suppliers

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

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

Allopurinol USDMF

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

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

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

Allopurinol JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Allopurinol Drug Master File in Japan (Allopurinol JDMF) empowers Allopurinol API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Allopurinol JDMF during the approval evaluation for pharmaceutical products. At the time of Allopurinol JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Allopurinol suppliers with JDMF on PharmaCompass.

Allopurinol KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Allopurinol Drug Master File in Korea (Allopurinol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Allopurinol. The MFDS reviews the Allopurinol KDMF as part of the drug registration process and uses the information provided in the Allopurinol KDMF to evaluate the safety and efficacy of the drug.

After submitting a Allopurinol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Allopurinol API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Allopurinol suppliers with KDMF on PharmaCompass.

Allopurinol CEP

A Allopurinol CEP of the European Pharmacopoeia monograph is often referred to as a Allopurinol Certificate of Suitability (COS). The purpose of a Allopurinol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Allopurinol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Allopurinol to their clients by showing that a Allopurinol CEP has been issued for it. The manufacturer submits a Allopurinol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Allopurinol CEP holder for the record. Additionally, the data presented in the Allopurinol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Allopurinol DMF.

A Allopurinol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Allopurinol CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Allopurinol suppliers with CEP (COS) on PharmaCompass.

Allopurinol WC

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

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

Allopurinol 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 Allopurinol as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Allopurinol GMP

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

Allopurinol CoA

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

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

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