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DRUG PRODUCT COMPOSITIONS0
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| Molecular Weight | 136.11 g/mol |
|---|---|
| Molecular Formula | C5H4N4O |
| XLogP3 | -0.5 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 2 |
| Rotatable Bond Count | 0 |
| Exact Mass | 136.03851076 g/mol |
| Monoisotopic Mass | 136.03851076 g/mol |
| Topological Polar Surface Area | 65.8 A^2 |
| Heavy Atom Count | 10 |
| Formal Charge | 0 |
| Complexity | 275 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 10 | |
|---|---|
| Drug Name | Allopurinol |
| PubMed Health | Allopurinol |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | Allopurinol 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 Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Watson Labs; Vintage Pharms; Ipca Labs; Mutual Pharm; Apotex; Accord Hlthcare; Sun Pharm Inds; Northstar Hlthcare; Mylan |
| 2 of 10 | |
|---|---|
| Drug Name | Allopurinol sodium |
| PubMed Health | Allopurinol (Injection) |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | ALOPRIM (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 Ingredient | Allopurinol sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Eurohlth Intl |
| 3 of 10 | |
|---|---|
| Drug Name | Aloprim |
| PubMed Health | Allopurinol |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | ZYLOPRIM (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 Ingredient | Allopurinol sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Mylan Institutional |
| 4 of 10 | |
|---|---|
| Drug Name | Lopurin |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Dr Reddys La |
| 5 of 10 | |
|---|---|
| Drug Name | Zyloprim |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Prometheus Labs |
| 6 of 10 | |
|---|---|
| Drug Name | Allopurinol |
| PubMed Health | Allopurinol |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | Allopurinol 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 Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Watson Labs; Vintage Pharms; Ipca Labs; Mutual Pharm; Apotex; Accord Hlthcare; Sun Pharm Inds; Northstar Hlthcare; Mylan |
| 7 of 10 | |
|---|---|
| Drug Name | Allopurinol sodium |
| PubMed Health | Allopurinol (Injection) |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | ALOPRIM (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 Ingredient | Allopurinol sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Eurohlth Intl |
| 8 of 10 | |
|---|---|
| Drug Name | Aloprim |
| PubMed Health | Allopurinol |
| Drug Classes | Antigout, Urinary Stone Agent |
| Drug Label | ZYLOPRIM (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 Ingredient | Allopurinol sodium |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | eq 500mg base/vial |
| Market Status | Prescription |
| Company | Mylan Institutional |
| 9 of 10 | |
|---|---|
| Drug Name | Lopurin |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Dr Reddys La |
| 10 of 10 | |
|---|---|
| Drug Name | Zyloprim |
| Active Ingredient | Allopurinol |
| Dosage Form | Tablet |
| Route | Oral |
| Strength | 300mg; 100mg |
| Market Status | Prescription |
| Company | Prometheus Labs |
API SUPPLIERS
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USDMF
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INTERMEDIATE SUPPLIERS
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Allopurinol Zentiva
Dosage Form : Tabl
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Allopurinol Zentiva
Dosage Form : Tabl
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Allopurinol Zentiva
Dosage Form : Tabl
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Sweden
Brand Name : Zyloric
Dosage Form : TABLET
Dosage Strength : 100 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Sweden
Brand Name : Zyloric
Dosage Form : TABLET
Dosage Strength : 300 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Norway
Brand Name : Zyloric
Dosage Form : Antic-calc Tablet
Dosage Strength : 100 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Norway
Brand Name : Zyloric
Dosage Form : Antic-calc Tablet
Dosage Strength : 100 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Norway
Brand Name : Zyloric
Dosage Form : Antic-calc Tablet
Dosage Strength : 300 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Norway
Brand Name : Zyloric
Dosage Form : Antic-calc Tablet
Dosage Strength : 300 mg
Packaging : Box
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Zyloric 300
Dosage Form : Tabl
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 16084
DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 16084
DOSAGE - TABLET;ORAL - 300MG
USFDA APPLICATION NUMBER - 16084
DOSAGE - TABLET;ORAL - 200MG;200MG
USFDA APPLICATION NUMBER - 209203
DOSAGE - TABLET;ORAL - 300MG;200MG
USFDA APPLICATION NUMBER - 209203
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Patents & EXCLUSIVITIES
US Patents
Patent Expiration Date : 2028-11-26
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
Patent Expiration Date : 2028-11-26
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
Patent Expiration Date : 2031-12-28
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
Patent Expiration Date : 2031-12-28
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
Patent Expiration Date : 2029-12-22
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
Patent Expiration Date : 2032-02-29
US Patent Number : 8546436
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 209203
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2032-02-29
Patent Expiration Date : 2029-04-29
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
Patent Expiration Date : 2032-02-29
US Patent Number : 8546436
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 209203
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2032-02-29
Patent Expiration Date : 2031-08-01
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
Patent Expiration Date : 2025-08-25
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
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.
A Allopurinol Alphapharm Brand manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Allopurinol Alphapharm Brand, including repackagers and relabelers. The FDA regulates Allopurinol Alphapharm Brand manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Allopurinol Alphapharm Brand 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 Alphapharm Brand manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Allopurinol Alphapharm Brand supplier is an individual or a company that provides Allopurinol Alphapharm Brand active pharmaceutical ingredient (API) or Allopurinol Alphapharm Brand finished formulations upon request. The Allopurinol Alphapharm Brand suppliers may include Allopurinol Alphapharm Brand API manufacturers, exporters, distributors and traders.
click here to find a list of Allopurinol Alphapharm Brand suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Allopurinol Alphapharm Brand DMF (Drug Master File) is a document detailing the whole manufacturing process of Allopurinol Alphapharm Brand active pharmaceutical ingredient (API) in detail. Different forms of Allopurinol Alphapharm Brand DMFs exist exist since differing nations have different regulations, such as Allopurinol Alphapharm Brand USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Allopurinol Alphapharm Brand DMF submitted to regulatory agencies in the US is known as a USDMF. Allopurinol Alphapharm Brand USDMF includes data on Allopurinol Alphapharm Brand's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Allopurinol Alphapharm Brand USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Allopurinol Alphapharm Brand suppliers with USDMF on PharmaCompass.
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 Alphapharm Brand Drug Master File in Japan (Allopurinol Alphapharm Brand JDMF) empowers Allopurinol Alphapharm Brand 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 Alphapharm Brand JDMF during the approval evaluation for pharmaceutical products. At the time of Allopurinol Alphapharm Brand 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 Alphapharm Brand suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Allopurinol Alphapharm Brand Drug Master File in Korea (Allopurinol Alphapharm Brand KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Allopurinol Alphapharm Brand. The MFDS reviews the Allopurinol Alphapharm Brand KDMF as part of the drug registration process and uses the information provided in the Allopurinol Alphapharm Brand KDMF to evaluate the safety and efficacy of the drug.
After submitting a Allopurinol Alphapharm Brand 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 Alphapharm Brand API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Allopurinol Alphapharm Brand suppliers with KDMF on PharmaCompass.
A Allopurinol Alphapharm Brand CEP of the European Pharmacopoeia monograph is often referred to as a Allopurinol Alphapharm Brand Certificate of Suitability (COS). The purpose of a Allopurinol Alphapharm Brand CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Allopurinol Alphapharm Brand EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Allopurinol Alphapharm Brand to their clients by showing that a Allopurinol Alphapharm Brand CEP has been issued for it. The manufacturer submits a Allopurinol Alphapharm Brand CEP (COS) as part of the market authorization procedure, and it takes on the role of a Allopurinol Alphapharm Brand CEP holder for the record. Additionally, the data presented in the Allopurinol Alphapharm Brand CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Allopurinol Alphapharm Brand DMF.
A Allopurinol Alphapharm Brand CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Allopurinol Alphapharm Brand 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 Alphapharm Brand suppliers with CEP (COS) on PharmaCompass.
A Allopurinol Alphapharm Brand written confirmation (Allopurinol Alphapharm Brand WC) is an official document issued by a regulatory agency to a Allopurinol Alphapharm Brand manufacturer, verifying that the manufacturing facility of a Allopurinol Alphapharm Brand active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Allopurinol Alphapharm Brand APIs or Allopurinol Alphapharm Brand finished pharmaceutical products to another nation, regulatory agencies frequently require a Allopurinol Alphapharm Brand WC (written confirmation) as part of the regulatory process.
click here to find a list of Allopurinol Alphapharm Brand suppliers with Written Confirmation (WC) on PharmaCompass.
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 Alphapharm Brand as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Allopurinol Alphapharm Brand API and other APIs are published in this directory by the FDA.
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 Alphapharm Brand 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.
The NDC directory also contains data on finished compounded human drug products that contain Allopurinol Alphapharm Brand and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Allopurinol Alphapharm Brand NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Allopurinol Alphapharm Brand suppliers with NDC on PharmaCompass.
Allopurinol Alphapharm Brand 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 Alphapharm Brand 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 Alphapharm Brand GMP manufacturer or Allopurinol Alphapharm Brand GMP API supplier for your needs.
A Allopurinol Alphapharm Brand CoA (Certificate of Analysis) is a formal document that attests to Allopurinol Alphapharm Brand's compliance with Allopurinol Alphapharm Brand specifications and serves as a tool for batch-level quality control.
Allopurinol Alphapharm Brand CoA mostly includes findings from lab analyses of a specific batch. For each Allopurinol Alphapharm Brand 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 Alphapharm Brand may be tested according to a variety of international standards, such as European Pharmacopoeia (Allopurinol Alphapharm Brand EP), Allopurinol Alphapharm Brand JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Allopurinol Alphapharm Brand USP).
