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USDMF
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-15
Pay. Date : 2013-12-24
DMF Number : 22664
Submission : 2009-03-23
Status :
Type : II
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Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Mesna 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 Mesna manufacturer or Mesna supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mesna manufacturer or Mesna supplier.
PharmaCompass also assists you with knowing the Mesna API Price utilized in the formulation of products. Mesna API Price is not always fixed or binding as the Mesna Price is obtained through a variety of data sources. The Mesna Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mistabron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mistabron, including repackagers and relabelers. The FDA regulates Mistabron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mistabron 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 Mistabron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mistabron supplier is an individual or a company that provides Mistabron active pharmaceutical ingredient (API) or Mistabron finished formulations upon request. The Mistabron suppliers may include Mistabron API manufacturers, exporters, distributors and traders.
click here to find a list of Mistabron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mistabron DMF (Drug Master File) is a document detailing the whole manufacturing process of Mistabron active pharmaceutical ingredient (API) in detail. Different forms of Mistabron DMFs exist exist since differing nations have different regulations, such as Mistabron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mistabron DMF submitted to regulatory agencies in the US is known as a USDMF. Mistabron USDMF includes data on Mistabron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mistabron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mistabron 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 Mistabron Drug Master File in Japan (Mistabron JDMF) empowers Mistabron 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 Mistabron JDMF during the approval evaluation for pharmaceutical products. At the time of Mistabron 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 Mistabron suppliers with JDMF on PharmaCompass.
A Mistabron CEP of the European Pharmacopoeia monograph is often referred to as a Mistabron Certificate of Suitability (COS). The purpose of a Mistabron CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mistabron EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mistabron to their clients by showing that a Mistabron CEP has been issued for it. The manufacturer submits a Mistabron CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mistabron CEP holder for the record. Additionally, the data presented in the Mistabron CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mistabron DMF.
A Mistabron CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mistabron 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 Mistabron suppliers with CEP (COS) on PharmaCompass.
A Mistabron written confirmation (Mistabron WC) is an official document issued by a regulatory agency to a Mistabron manufacturer, verifying that the manufacturing facility of a Mistabron active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mistabron APIs or Mistabron finished pharmaceutical products to another nation, regulatory agencies frequently require a Mistabron WC (written confirmation) as part of the regulatory process.
click here to find a list of Mistabron 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 Mistabron as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mistabron 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 Mistabron 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 Mistabron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mistabron NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mistabron suppliers with NDC on PharmaCompass.
Mistabron 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 Mistabron 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 Mistabron GMP manufacturer or Mistabron GMP API supplier for your needs.
A Mistabron CoA (Certificate of Analysis) is a formal document that attests to Mistabron's compliance with Mistabron specifications and serves as a tool for batch-level quality control.
Mistabron CoA mostly includes findings from lab analyses of a specific batch. For each Mistabron 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.
Mistabron may be tested according to a variety of international standards, such as European Pharmacopoeia (Mistabron EP), Mistabron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mistabron USP).
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