Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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.
Certificate Number : R1-CEP 1996-032 - Rev 05
Status : Valid
Issue Date : 2019-08-09
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
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.
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 : 2019-03-29
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Date of Issue : 2025-09-02
Valid Till : 2028-07-02
Written Confirmation Number : WC-0218
Address of the Firm : A-5/2, Late Parshuram Industrial Area, MIDC, Tal-Khed, Dist. Ratnagiri-415 722, ...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Date of Issue : 2025-09-02
Valid Till : 2028-07-02
Written Confirmation Number : WC-0218
Address of the Firm : A-5/2, Late Parshuram Industrial Area, MIDC, Tal-Khed, Dist. Ratnagiri-415 722, ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.
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
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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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REF. STANDARDS & IMPURITIES
ANALYTICAL
Analytical Methods
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(I) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Allopurinol(I), including repackagers and relabelers. The FDA regulates Allopurinol(I) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Allopurinol(I) 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(I) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Allopurinol(I) supplier is an individual or a company that provides Allopurinol(I) active pharmaceutical ingredient (API) or Allopurinol(I) finished formulations upon request. The Allopurinol(I) suppliers may include Allopurinol(I) API manufacturers, exporters, distributors and traders.
click here to find a list of Allopurinol(I) suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Allopurinol(I) DMF (Drug Master File) is a document detailing the whole manufacturing process of Allopurinol(I) active pharmaceutical ingredient (API) in detail. Different forms of Allopurinol(I) DMFs exist exist since differing nations have different regulations, such as Allopurinol(I) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Allopurinol(I) DMF submitted to regulatory agencies in the US is known as a USDMF. Allopurinol(I) USDMF includes data on Allopurinol(I)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Allopurinol(I) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Allopurinol(I) 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(I) Drug Master File in Japan (Allopurinol(I) JDMF) empowers Allopurinol(I) 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(I) JDMF during the approval evaluation for pharmaceutical products. At the time of Allopurinol(I) 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(I) 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(I) Drug Master File in Korea (Allopurinol(I) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Allopurinol(I). The MFDS reviews the Allopurinol(I) KDMF as part of the drug registration process and uses the information provided in the Allopurinol(I) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Allopurinol(I) 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(I) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Allopurinol(I) suppliers with KDMF on PharmaCompass.
A Allopurinol(I) CEP of the European Pharmacopoeia monograph is often referred to as a Allopurinol(I) Certificate of Suitability (COS). The purpose of a Allopurinol(I) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Allopurinol(I) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Allopurinol(I) to their clients by showing that a Allopurinol(I) CEP has been issued for it. The manufacturer submits a Allopurinol(I) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Allopurinol(I) CEP holder for the record. Additionally, the data presented in the Allopurinol(I) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Allopurinol(I) DMF.
A Allopurinol(I) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Allopurinol(I) 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(I) suppliers with CEP (COS) on PharmaCompass.
A Allopurinol(I) written confirmation (Allopurinol(I) WC) is an official document issued by a regulatory agency to a Allopurinol(I) manufacturer, verifying that the manufacturing facility of a Allopurinol(I) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Allopurinol(I) APIs or Allopurinol(I) finished pharmaceutical products to another nation, regulatory agencies frequently require a Allopurinol(I) WC (written confirmation) as part of the regulatory process.
click here to find a list of Allopurinol(I) 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(I) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Allopurinol(I) 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(I) 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(I) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Allopurinol(I) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Allopurinol(I) suppliers with NDC on PharmaCompass.
Allopurinol(I) 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(I) 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(I) GMP manufacturer or Allopurinol(I) GMP API supplier for your needs.
A Allopurinol(I) CoA (Certificate of Analysis) is a formal document that attests to Allopurinol(I)'s compliance with Allopurinol(I) specifications and serves as a tool for batch-level quality control.
Allopurinol(I) CoA mostly includes findings from lab analyses of a specific batch. For each Allopurinol(I) 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(I) may be tested according to a variety of international standards, such as European Pharmacopoeia (Allopurinol(I) EP), Allopurinol(I) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Allopurinol(I) USP).
