Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
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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 :
Pay. Date :
DMF Number : 37104
Submission : 2023-01-20
Status :
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 :
Type : II
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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
Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.
Allopurinol, Synthetic Route B
Certificate Number : CEP 2014-364 - Rev 01
Status : Valid
Issue Date : 2023-11-27
Type : Chemical
Substance Number : 576
Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.
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.
Certificate Number : CEP 1998-118 - Rev 08
Status : Valid
Issue Date : 2025-07-11
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.
Allopurinol, Allopurinol P-process
Certificate Number : CEP 2014-117 - Rev 03
Status : Valid
Issue Date : 2025-06-30
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.
Certificate Number : CEP 1999-007 - Rev 08
Status : Valid
Issue Date : 2025-04-01
Type : Chemical
Substance Number : 576
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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...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...
Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.
About the Company : Egis is an EU-based, vertically integrated generic pharmaceutical company with over 110 years of experience across the entire value chain. Renowned for reliable supply, proprietary...
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...
Since 1980, Octavius Pharma has been empowering lives by delivering trusted healthcare solutions, including DC granules, APIs, and FDFs
About the Company : Octavius Pharma is a global leader in Directly Compressible (DC) Granules with over 45 years of expertise in formulation development, manufacturing, and commercialization. Our port...
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...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herba...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Zyloric
Dosage Form : Tablet
Dosage Strength : 100MG
Packaging :
Approval Date : 2005-11-10
Application Number :
Regulatory Info : Authorised
Registration Country : Malta
Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Zyloric
Dosage Form : Tablet
Dosage Strength : 300MG
Packaging :
Approval Date : 2005-11-10
Application Number :
Regulatory Info : Authorised
Registration Country : Malta
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Zyloric
Dosage Form : Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 02-10-1967
Application Number : 1.97E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Zyloric
Dosage Form : Tablet
Dosage Strength : 300mg
Packaging :
Approval Date : 27-08-1976
Application Number : 1.98E+13
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Allopurinol \"Orion\"
Dosage Form : Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 05-02-2015
Application Number : 28105340413
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Allopurinol \"Orion\"
Dosage Form : Tablet
Dosage Strength : 300mg
Packaging :
Approval Date : 05-02-2015
Application Number : 28105340513
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Allopurinol Orion
Dosage Form : Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 22-01-2015
Application Number : 2.01E+13
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Allopurinol Orion
Dosage Form : Tablet
Dosage Strength : 300mg
Packaging :
Approval Date : 22-01-2015
Application Number : 2.01E+13
Regulatory Info : Approved
Registration Country : Sweden
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Allopurinol Pensa
Dosage Form : Tablet
Dosage Strength : 300MG
Packaging :
Approval Date : 23-11-2000
Application Number : 63482
Regulatory Info : Authorized
Registration Country : Spain
Towa International works to research, develop, manufacture, and market, generic and value-added medicines to patients around the world.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Allopurinol Pensa
Dosage Form : Tablet
Dosage Strength : 100MG
Packaging :
Approval Date : 23-11-2000
Application Number : 63481
Regulatory Info : Authorized
Registration Country : Spain
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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
46
PharmaCompass offers a list of Allopurinol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A Allopurinol Hennig Brand manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Allopurinol Hennig Brand, including repackagers and relabelers. The FDA regulates Allopurinol Hennig Brand manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Allopurinol Hennig 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 Hennig Brand manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Allopurinol Hennig Brand supplier is an individual or a company that provides Allopurinol Hennig Brand active pharmaceutical ingredient (API) or Allopurinol Hennig Brand finished formulations upon request. The Allopurinol Hennig Brand suppliers may include Allopurinol Hennig Brand API manufacturers, exporters, distributors and traders.
click here to find a list of Allopurinol Hennig Brand suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Allopurinol Hennig Brand DMF (Drug Master File) is a document detailing the whole manufacturing process of Allopurinol Hennig Brand active pharmaceutical ingredient (API) in detail. Different forms of Allopurinol Hennig Brand DMFs exist exist since differing nations have different regulations, such as Allopurinol Hennig Brand USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Allopurinol Hennig Brand DMF submitted to regulatory agencies in the US is known as a USDMF. Allopurinol Hennig Brand USDMF includes data on Allopurinol Hennig Brand's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Allopurinol Hennig Brand USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Allopurinol Hennig 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 Hennig Brand Drug Master File in Japan (Allopurinol Hennig Brand JDMF) empowers Allopurinol Hennig 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 Hennig Brand JDMF during the approval evaluation for pharmaceutical products. At the time of Allopurinol Hennig 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 Hennig 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 Hennig Brand Drug Master File in Korea (Allopurinol Hennig Brand KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Allopurinol Hennig Brand. The MFDS reviews the Allopurinol Hennig Brand KDMF as part of the drug registration process and uses the information provided in the Allopurinol Hennig Brand KDMF to evaluate the safety and efficacy of the drug.
After submitting a Allopurinol Hennig 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 Hennig Brand API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Allopurinol Hennig Brand suppliers with KDMF on PharmaCompass.
A Allopurinol Hennig Brand CEP of the European Pharmacopoeia monograph is often referred to as a Allopurinol Hennig Brand Certificate of Suitability (COS). The purpose of a Allopurinol Hennig Brand CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Allopurinol Hennig Brand EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Allopurinol Hennig Brand to their clients by showing that a Allopurinol Hennig Brand CEP has been issued for it. The manufacturer submits a Allopurinol Hennig Brand CEP (COS) as part of the market authorization procedure, and it takes on the role of a Allopurinol Hennig Brand CEP holder for the record. Additionally, the data presented in the Allopurinol Hennig Brand CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Allopurinol Hennig Brand DMF.
A Allopurinol Hennig Brand CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Allopurinol Hennig 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 Hennig Brand suppliers with CEP (COS) on PharmaCompass.
A Allopurinol Hennig Brand written confirmation (Allopurinol Hennig Brand WC) is an official document issued by a regulatory agency to a Allopurinol Hennig Brand manufacturer, verifying that the manufacturing facility of a Allopurinol Hennig Brand active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Allopurinol Hennig Brand APIs or Allopurinol Hennig Brand finished pharmaceutical products to another nation, regulatory agencies frequently require a Allopurinol Hennig Brand WC (written confirmation) as part of the regulatory process.
click here to find a list of Allopurinol Hennig 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 Hennig Brand as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Allopurinol Hennig 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 Hennig 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 Hennig Brand and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Allopurinol Hennig Brand NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Allopurinol Hennig Brand suppliers with NDC on PharmaCompass.
Allopurinol Hennig 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 Hennig Brand GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Allopurinol Hennig Brand GMP manufacturer or Allopurinol Hennig Brand GMP API supplier for your needs.
A Allopurinol Hennig Brand CoA (Certificate of Analysis) is a formal document that attests to Allopurinol Hennig Brand's compliance with Allopurinol Hennig Brand specifications and serves as a tool for batch-level quality control.
Allopurinol Hennig Brand CoA mostly includes findings from lab analyses of a specific batch. For each Allopurinol Hennig 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 Hennig Brand may be tested according to a variety of international standards, such as European Pharmacopoeia (Allopurinol Hennig Brand EP), Allopurinol Hennig Brand JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Allopurinol Hennig Brand USP).
