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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
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37104
Submission : 2023-01-20
Status : Active
Type : II
Certificate Number : CEP 2023-029 - Rev 00
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 576
Status : Valid
NDC Package Code : 49716-328
Start Marketing Date : 2023-10-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Jai Radhe Sales is your partner for all your sourcing needs.
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Certificate Number : R1-CEP 1996-032 - Rev 05
Issue Date : 2019-08-09
Type : Chemical
Substance Number : 576
Status : Valid
Registration Number : 231MF10077
Registrant's Address : H-1106 BUDAPEST KERESZTURI UT 30-38 HUNGARY
Initial Date of Registration : 2019-03-29
Latest Date of Registration :
Registrant Name : Masung LS Co., Ltd.
Registration Date : 2021-01-25
Registration Number : 20210125-209-J-511
Manufacturer Name : EGIS Pharmaceuticals Plc.
Manufacturer Address : Kereszturi ut 30-38., Budapest, 1106, Hungary
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39568
Submission : 2024-03-05
Status : Active
Type : II
Date of Issue : 2025-09-02
Valid Till : 2028-07-02
Written Confirmation Number : WC-0218
Address of the Firm :
NDC Package Code : 61281-9750
Start Marketing Date : 2023-07-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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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 :
Pay. Date :
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 :
Pay. Date :
DMF Number : 39568
Submission : 2024-03-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3480
Submission : 1979-03-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4307
Submission : 1981-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
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 :
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2534
Submission : 1975-10-13
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
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...
Jai Radhe Sales is your partner for all your sourcing needs.
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...
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
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...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
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...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
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...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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...
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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
10
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 Progout manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Progout, including repackagers and relabelers. The FDA regulates Progout manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Progout 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 Progout manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Progout supplier is an individual or a company that provides Progout active pharmaceutical ingredient (API) or Progout finished formulations upon request. The Progout suppliers may include Progout API manufacturers, exporters, distributors and traders.
click here to find a list of Progout suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Progout DMF (Drug Master File) is a document detailing the whole manufacturing process of Progout active pharmaceutical ingredient (API) in detail. Different forms of Progout DMFs exist exist since differing nations have different regulations, such as Progout USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Progout DMF submitted to regulatory agencies in the US is known as a USDMF. Progout USDMF includes data on Progout's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Progout USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Progout 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 Progout Drug Master File in Japan (Progout JDMF) empowers Progout 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 Progout JDMF during the approval evaluation for pharmaceutical products. At the time of Progout 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 Progout 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 Progout Drug Master File in Korea (Progout KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Progout. The MFDS reviews the Progout KDMF as part of the drug registration process and uses the information provided in the Progout KDMF to evaluate the safety and efficacy of the drug.
After submitting a Progout 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 Progout API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Progout suppliers with KDMF on PharmaCompass.
A Progout CEP of the European Pharmacopoeia monograph is often referred to as a Progout Certificate of Suitability (COS). The purpose of a Progout CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Progout EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Progout to their clients by showing that a Progout CEP has been issued for it. The manufacturer submits a Progout CEP (COS) as part of the market authorization procedure, and it takes on the role of a Progout CEP holder for the record. Additionally, the data presented in the Progout CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Progout DMF.
A Progout CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Progout 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 Progout suppliers with CEP (COS) on PharmaCompass.
A Progout written confirmation (Progout WC) is an official document issued by a regulatory agency to a Progout manufacturer, verifying that the manufacturing facility of a Progout active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Progout APIs or Progout finished pharmaceutical products to another nation, regulatory agencies frequently require a Progout WC (written confirmation) as part of the regulatory process.
click here to find a list of Progout 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 Progout as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Progout 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 Progout 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 Progout and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Progout NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Progout suppliers with NDC on PharmaCompass.
Progout 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 Progout 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 Progout GMP manufacturer or Progout GMP API supplier for your needs.
A Progout CoA (Certificate of Analysis) is a formal document that attests to Progout's compliance with Progout specifications and serves as a tool for batch-level quality control.
Progout CoA mostly includes findings from lab analyses of a specific batch. For each Progout 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.
Progout may be tested according to a variety of international standards, such as European Pharmacopoeia (Progout EP), Progout JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Progout USP).
