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DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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API SUPPLIERS
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
Jai Radhe Sales is your partner for all your sourcing needs.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.
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.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
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USDMF
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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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SPI Pharma
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Global Sales Information
US Medicaid Prescriptions
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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 Zyloric manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zyloric, including repackagers and relabelers. The FDA regulates Zyloric manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zyloric 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 Zyloric manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Zyloric supplier is an individual or a company that provides Zyloric active pharmaceutical ingredient (API) or Zyloric finished formulations upon request. The Zyloric suppliers may include Zyloric API manufacturers, exporters, distributors and traders.
click here to find a list of Zyloric suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Zyloric DMF (Drug Master File) is a document detailing the whole manufacturing process of Zyloric active pharmaceutical ingredient (API) in detail. Different forms of Zyloric DMFs exist exist since differing nations have different regulations, such as Zyloric USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zyloric DMF submitted to regulatory agencies in the US is known as a USDMF. Zyloric USDMF includes data on Zyloric's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zyloric USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zyloric 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 Zyloric Drug Master File in Japan (Zyloric JDMF) empowers Zyloric 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 Zyloric JDMF during the approval evaluation for pharmaceutical products. At the time of Zyloric 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 Zyloric 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 Zyloric Drug Master File in Korea (Zyloric KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zyloric. The MFDS reviews the Zyloric KDMF as part of the drug registration process and uses the information provided in the Zyloric KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zyloric 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 Zyloric API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zyloric suppliers with KDMF on PharmaCompass.
A Zyloric CEP of the European Pharmacopoeia monograph is often referred to as a Zyloric Certificate of Suitability (COS). The purpose of a Zyloric CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zyloric EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zyloric to their clients by showing that a Zyloric CEP has been issued for it. The manufacturer submits a Zyloric CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zyloric CEP holder for the record. Additionally, the data presented in the Zyloric CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zyloric DMF.
A Zyloric CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zyloric 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 Zyloric suppliers with CEP (COS) on PharmaCompass.
A Zyloric written confirmation (Zyloric WC) is an official document issued by a regulatory agency to a Zyloric manufacturer, verifying that the manufacturing facility of a Zyloric active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zyloric APIs or Zyloric finished pharmaceutical products to another nation, regulatory agencies frequently require a Zyloric WC (written confirmation) as part of the regulatory process.
click here to find a list of Zyloric 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 Zyloric as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zyloric 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 Zyloric 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 Zyloric and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zyloric NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zyloric suppliers with NDC on PharmaCompass.
Zyloric 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 Zyloric GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Zyloric GMP manufacturer or Zyloric GMP API supplier for your needs.
A Zyloric CoA (Certificate of Analysis) is a formal document that attests to Zyloric's compliance with Zyloric specifications and serves as a tool for batch-level quality control.
Zyloric CoA mostly includes findings from lab analyses of a specific batch. For each Zyloric 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.
Zyloric may be tested according to a variety of international standards, such as European Pharmacopoeia (Zyloric EP), Zyloric JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zyloric USP).
