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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

API Reference Price

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04-Jan-2021
30-Apr-2025
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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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ABOUT THIS PAGE

Looking for / Allopurinol API manufacturers, exporters & distributors?

Allopurinol manufacturers, exporters & distributors 1

61

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

Alopurinol Manufacturers

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

Alopurinol Suppliers

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

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

Alopurinol USDMF

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

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

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

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

Alopurinol KDMF

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

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

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

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

Alopurinol CEP

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

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

Alopurinol WC

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

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

Alopurinol 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 Alopurinol as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Alopurinol GMP

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

Alopurinol CoA

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

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

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