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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

Listed Suppliers

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01

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

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Allopurinol

About the Company : IOL Chemicals and Pharmaceuticals Limited, with over three decades of experience, is an innovation-driven company specializing in bulk drugs, intermediates, and specialty chemicals...

IOL Chemicals and Pharmaceuticals Limited, with over three decades of experience, is an innovation-driven company specializing in bulk drugs, intermediates, and specialty chemicals. As an API-based manufacturer, it offers economies of scale and cost advantages with substantial production capacity. Its API portfolio covers pain management, anti-diabetic, anti-hypertensive, and anti-convulsant categories. IOL Chemicals is backward-integrated, producing all intermediates and key starting materials for ibuprofen. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
IOL Chemicals

02

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Virtual BoothJai Radhe Sales is your partner for all your sourcing needs.

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Allopurinol

About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...

Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and regulatory support, and strives for global standards. Known for quality and affordability, it has established a niche through innovative methods and exports to nearly every continent. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Jai Radhe Sales

03

JPN Pharma

India
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Virtual BoothJPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry

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Allopurinol

About the Company : JPN Pharma is an Indian pharmaceutical company specializing in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug intermediates. Headquartered i...

JPN Pharma is an Indian pharmaceutical company specializing in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug intermediates. Headquartered in Mumbai, the company operates three state-of-the-art manufacturing facilities in Tarapur, Maharashtra, compliant with international regulatory standards. With CEP and WC approvals, JPN Pharma has expertise in complex chemical reactions and hazardous material handling, supported by R&D capabilities and strict QA/QC systems for global markets. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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04

LGM Pharma

U.S.A
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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Allopurinol

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulation, analytical method development and testing, custom API synthesis, regulatory support, and commercial manufacturing. Supported by a network of over 300 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
LGM Pharma CB

05

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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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Allopurinol

About the Company : Egis, part of the Servier Group, manufactures products at three EMA-, FDA-, ANVISA-, PMDA-, and KFDA-certified sites in Hungary. It sells branded products in 18 countries and reach...

Egis, part of the Servier Group, manufactures products at three EMA-, FDA-, ANVISA-, PMDA-, and KFDA-certified sites in Hungary. It sells branded products in 18 countries and reaches 100 countries with its APIs and finished products. Egis focuses on cardiovascular and central nervous system diseases, with offerings in diabetology, dermatology, and wound care. Its R&D emphasizes high-quality, value-added branded generics, and since 2023, Egis also provides CDMO and CMO services. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Egis Pharmaceuticals

06

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Virtual BoothGonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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Allopurinol

About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...

Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology products. The company is supported by a dedicated team and promoters with over 25 years of experience in manufacturing, product promotion, and regulatory audits across markets including the EU, Mexico, China, Korea, and Russia. Gonane Pharma is also engaged with Japanese customers and continues to expand into new markets. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Gonane Pharma

07

HRV Pharma

India
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Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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Allopurinol

About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
HRV Global Life Sciences

08

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Virtual BoothOctavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.

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Allopurinol

About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfoli...

Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of experience in formulation development, manufacturing, and commercialization. Its portfolio includes DC granules, herbal and food supplements, APIs, and finished formulations such as tablets, capsules, syrups, and ointments. With WHO-GMP certification and a DSIR-certified R&D center, the company ensures quality and innovation, exporting to LATAM, the Middle East, Africa, Asia, and CIS regions, and offering formulation and marketing support. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Octavius Pharma

09

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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Allopurinol

About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...

Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its facilities in Lote and Ambernath are approved by USFDA, EUGMP, Health Canada, and other agencies. Specializing in antihistamines, antiallergics, vitamins, anesthetics, and anti-asthmatics, Supriya serves 1500+ customers in over 86 countries, with 15+ USDMFs, 10+ CEPs, and a 1050 KL manufacturing capacity. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Supriya

10

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Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Allopurinol

About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Exports Private Limited was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Tenatra
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API Reference Price

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01-Jan-2022
31-Dec-2025
KGS
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API Imports and Exports

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

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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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Excipients by Applications

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Fillers, Diluents & Binders

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Chewable & Orodispersible Aids

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Global Sales Information

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Regulatory FDF Prices

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01

Brand Name : Zyloric

Netherlands
  • fda
  • EDQM
  • WHO-GMP

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RX/OTC/DISCN :

Allopurinol

Dosage Form : Antic-calc Tablet

Dosage Strength : 100 mg

Price Per Pack (Euro) : 8.503

Published in :

Country : Norway

RX/OTC/DISCN :

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02

Brand Name : Allopurinol Orion

Finland

Allopurinol

Dosage Form : Antic-calc Tablet

Dosage Strength : 100 mg

Price Per Pack (Euro) : 8.503

Published in :

Country : Norway

RX/OTC/DISCN :

Fermion Orion Company Banner

03

Brand Name : Zyloric

Netherlands
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAspen API. More than just an API™

Flag Netherlands
Digital Content Digital Content

RX/OTC/DISCN :

Allopurinol

Dosage Form : Antic-calc Tablet

Dosage Strength : 100 mg

Price Per Pack (Euro) : 8.503

Published in :

Country : Norway

RX/OTC/DISCN :

Aspen API Comapny Banner

04

Brand Name : Zyloric

Netherlands
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAspen API. More than just an API™

Flag Netherlands
Digital Content Digital Content

RX/OTC/DISCN :

Allopurinol

Dosage Form : Antic-calc Tablet

Dosage Strength : 300 mg

Price Per Pack (Euro) : 19.239

Published in :

Country : Norway

RX/OTC/DISCN :

Aspen API Comapny Banner

05

Brand Name : Zyloric

Netherlands
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAspen API. More than just an API™

Flag Netherlands
Digital Content Digital Content

RX/OTC/DISCN :

Allopurinol

Dosage Form : Antic-calc Tablet

Dosage Strength : 300 mg

Price Per Pack (Euro) : 19.239

Published in :

Country : Norway

RX/OTC/DISCN :

Aspen API Comapny Banner

06

Brand Name : Allopurinol Orion

Finland

Allopurinol

Dosage Form : Antic-calc Tablet

Dosage Strength : 300 mg

Price Per Pack (Euro) : 19.239

Published in :

Country : Norway

RX/OTC/DISCN :

Fermion Orion Company Banner

07

Brand Name : Allopurinol

Italy
arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Allopurinol

Italy
arrow
BIO Partnering at JPM
Not Confirmed

Allopurinol

Dosage Form : Allopurinol 100Mg 50 Combined Or...

Dosage Strength : 50 CPR 100 mg

Price Per Pack (Euro) : 2.07

Published in :

Country : Italy

RX/OTC/DISCN : Class A

blank

08

Brand Name : Allopurinol

Italy
arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Allopurinol

Italy
arrow
BIO Partnering at JPM
Not Confirmed

Allopurinol

Dosage Form : Allopurinol 100Mg 50 Combined Or...

Dosage Strength : 50 CPR 100 mg

Price Per Pack (Euro) : 2.07

Published in :

Country : Italy

RX/OTC/DISCN : Class A

blank

09

Brand Name : Allopurinol

Switzerland
arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Allopurinol

Switzerland
arrow
BIO Partnering at JPM
Not Confirmed

Allopurinol

Dosage Form : Allopurinol 100Mg 50 Combined Or...

Dosage Strength : 50 CPR 100 mg

Price Per Pack (Euro) : 2.07

Published in :

Country : Italy

RX/OTC/DISCN : Class A

blank

10

Brand Name : Uricodue

Country
arrow
BIO Partnering at JPM
Not Confirmed

Brand Name : Uricodue

Country
arrow
BIO Partnering at JPM
Not Confirmed

Allopurinol; Benziodarone

Dosage Form :

Dosage Strength : 30 Cpr 100 Mg + 50 Mg  

Price Per Pack (Euro) : 8.65

Published in :

Country : Italy

RX/OTC/DISCN : Class C

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Patents & EXCLUSIVITIES

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REF. STANDARDS & IMPURITIES

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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

Urbol Manufacturers

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

Urbol Suppliers

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

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

Urbol USDMF

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

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

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

Urbol 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 Urbol Drug Master File in Japan (Urbol JDMF) empowers Urbol 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 Urbol JDMF during the approval evaluation for pharmaceutical products. At the time of Urbol 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 Urbol suppliers with JDMF on PharmaCompass.

Urbol KDMF

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

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

After submitting a Urbol 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 Urbol API can apply through the Korea Drug Master File (KDMF).

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

Urbol CEP

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

A Urbol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Urbol 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 Urbol suppliers with CEP (COS) on PharmaCompass.

Urbol WC

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

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

Urbol 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 Urbol as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Urbol GMP

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

Urbol CoA

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

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

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