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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 : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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
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
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 : CEP 2014-364 - Rev 01
Issue Date : 2023-11-27
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.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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 : 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 : 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 : 2534
Submission : 1975-10-13
Status : Inactive
Type : II
Portfolio PDF
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Corporate PDF
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
Certificate Number : CEP 2023-029 - Rev 00
Status : Valid
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 576
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Allopurinol, Synthetic Route B
Certificate Number : CEP 2014-364 - Rev 01
Status : Valid
Issue Date : 2023-11-27
Type : Chemical
Substance Number : 576
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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
Status : Valid
Issue Date : 2019-08-09
Type : Chemical
Substance Number : 576
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Allopurinol, Allopurinol P-process
Certificate Number : CEP 2014-117 - Rev 02
Status : Valid
Issue Date : 2024-02-16
Type : Chemical
Substance Number : 576
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : R1-CEP 1999-007 - Rev 07
Status : Valid
Issue Date : 2023-07-21
Type : Chemical
Substance Number : 576
Certificate Number : R0-CEP 2007-189 - Rev 00
Status : Expired
Issue Date : 2010-06-30
Type : Chemical
Substance Number : 576
Certificate Number : R0-CEP 2003-213 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2004-10-13
Type : Chemical
Substance Number : 576
Certificate Number : R0-CEP 2004-189 - Rev 02
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2008-09-26
Type : Chemical
Substance Number : 576
Certificate Number : R1-CEP 1998-118 - Rev 07
Status : Valid
Issue Date : 2021-12-20
Type : Chemical
Substance Number : 576
Certificate Number : R1-CEP 2003-004 - Rev 02
Status : Valid
Issue Date : 2017-12-15
Type : Chemical
Substance Number : 576
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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
NDC Package Code : 49716-328
Start Marketing Date : 2023-10-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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
NDC Package Code : 14335-530
Start Marketing Date : 2024-07-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 14445-001
Start Marketing Date : 2008-01-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 57451-1166
Start Marketing Date : 2012-02-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51927-0070
Start Marketing Date : 2020-04-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 51927-0340
Start Marketing Date : 2024-06-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 36974-0018
Start Marketing Date : 2019-08-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 72375-0007
Start Marketing Date : 2022-09-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49452-0008
Start Marketing Date : 2000-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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INTERMEDIATE SUPPLIERS
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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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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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Allopurinol, including repackagers and relabelers. The FDA regulates Allopurinol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Allopurinol 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Allopurinol supplier is an individual or a company that provides Allopurinol active pharmaceutical ingredient (API) or Allopurinol finished formulations upon request. The Allopurinol suppliers may include Allopurinol API manufacturers, exporters, distributors and traders.
click here to find a list of Allopurinol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Allopurinol DMF (Drug Master File) is a document detailing the whole manufacturing process of Allopurinol active pharmaceutical ingredient (API) in detail. Different forms of Allopurinol DMFs exist exist since differing nations have different regulations, such as Allopurinol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Allopurinol DMF submitted to regulatory agencies in the US is known as a USDMF. Allopurinol USDMF includes data on Allopurinol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Allopurinol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Allopurinol 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 Drug Master File in Japan (Allopurinol JDMF) empowers Allopurinol 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Allopurinol 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 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 Drug Master File in Korea (Allopurinol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Allopurinol. The MFDS reviews the Allopurinol KDMF as part of the drug registration process and uses the information provided in the Allopurinol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Allopurinol 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Allopurinol suppliers with KDMF on PharmaCompass.
A Allopurinol CEP of the European Pharmacopoeia monograph is often referred to as a Allopurinol Certificate of Suitability (COS). The purpose of a Allopurinol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Allopurinol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Allopurinol to their clients by showing that a Allopurinol CEP has been issued for it. The manufacturer submits a Allopurinol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Allopurinol CEP holder for the record. Additionally, the data presented in the Allopurinol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Allopurinol DMF.
A Allopurinol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Allopurinol 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 suppliers with CEP (COS) on PharmaCompass.
A Allopurinol written confirmation (Allopurinol WC) is an official document issued by a regulatory agency to a Allopurinol manufacturer, verifying that the manufacturing facility of a Allopurinol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Allopurinol APIs or Allopurinol finished pharmaceutical products to another nation, regulatory agencies frequently require a Allopurinol WC (written confirmation) as part of the regulatory process.
click here to find a list of Allopurinol 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Allopurinol 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Allopurinol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Allopurinol suppliers with NDC on PharmaCompass.
Allopurinol 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 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 GMP manufacturer or Allopurinol GMP API supplier for your needs.
A Allopurinol CoA (Certificate of Analysis) is a formal document that attests to Allopurinol's compliance with Allopurinol specifications and serves as a tool for batch-level quality control.
Allopurinol CoA mostly includes findings from lab analyses of a specific batch. For each Allopurinol 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Allopurinol EP), Allopurinol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Allopurinol USP).
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