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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
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 37104
Submission : 2023-01-20
Status : Active
Type : II
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 39568
Submission : 2024-03-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 4307
Submission : 1981-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 4950
Submission : 1983-02-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5235
Submission : 1984-01-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 3480
Submission : 1979-03-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2870
Submission : 1977-02-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2506
Submission : 1975-08-13
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3583
Submission : 1979-07-22
Status : Inactive
Type : II
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2534
Submission : 1975-10-13
Status : Inactive
Type : II
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DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 16084
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USFDA APPLICATION NUMBER - 16084
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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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ABOUT THIS PAGE
A Gichtex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gichtex, including repackagers and relabelers. The FDA regulates Gichtex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gichtex 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 Gichtex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gichtex supplier is an individual or a company that provides Gichtex active pharmaceutical ingredient (API) or Gichtex finished formulations upon request. The Gichtex suppliers may include Gichtex API manufacturers, exporters, distributors and traders.
click here to find a list of Gichtex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gichtex DMF (Drug Master File) is a document detailing the whole manufacturing process of Gichtex active pharmaceutical ingredient (API) in detail. Different forms of Gichtex DMFs exist exist since differing nations have different regulations, such as Gichtex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gichtex DMF submitted to regulatory agencies in the US is known as a USDMF. Gichtex USDMF includes data on Gichtex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gichtex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gichtex 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 Gichtex Drug Master File in Japan (Gichtex JDMF) empowers Gichtex 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 Gichtex JDMF during the approval evaluation for pharmaceutical products. At the time of Gichtex 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 Gichtex 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 Gichtex Drug Master File in Korea (Gichtex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gichtex. The MFDS reviews the Gichtex KDMF as part of the drug registration process and uses the information provided in the Gichtex KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gichtex 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 Gichtex API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gichtex suppliers with KDMF on PharmaCompass.
A Gichtex CEP of the European Pharmacopoeia monograph is often referred to as a Gichtex Certificate of Suitability (COS). The purpose of a Gichtex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gichtex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gichtex to their clients by showing that a Gichtex CEP has been issued for it. The manufacturer submits a Gichtex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gichtex CEP holder for the record. Additionally, the data presented in the Gichtex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gichtex DMF.
A Gichtex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gichtex 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 Gichtex suppliers with CEP (COS) on PharmaCompass.
A Gichtex written confirmation (Gichtex WC) is an official document issued by a regulatory agency to a Gichtex manufacturer, verifying that the manufacturing facility of a Gichtex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gichtex APIs or Gichtex finished pharmaceutical products to another nation, regulatory agencies frequently require a Gichtex WC (written confirmation) as part of the regulatory process.
click here to find a list of Gichtex 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 Gichtex as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gichtex 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 Gichtex 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 Gichtex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gichtex NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gichtex suppliers with NDC on PharmaCompass.
Gichtex 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 Gichtex 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 Gichtex GMP manufacturer or Gichtex GMP API supplier for your needs.
A Gichtex CoA (Certificate of Analysis) is a formal document that attests to Gichtex's compliance with Gichtex specifications and serves as a tool for batch-level quality control.
Gichtex CoA mostly includes findings from lab analyses of a specific batch. For each Gichtex 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.
Gichtex may be tested according to a variety of international standards, such as European Pharmacopoeia (Gichtex EP), Gichtex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gichtex USP).
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