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API SUPPLIERS
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USDMF
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Drugs in Development
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DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 12836
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 12836
DOSAGE - TABLET;ORAL - 75MG
USFDA APPLICATION NUMBER - 12836
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 25M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20884
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REF. STANDARDS & IMPURITIES
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ANALYTICAL
ABOUT THIS PAGE
A Dipyridamole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dipyridamole, including repackagers and relabelers. The FDA regulates Dipyridamole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dipyridamole 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 Dipyridamole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dipyridamole supplier is an individual or a company that provides Dipyridamole active pharmaceutical ingredient (API) or Dipyridamole finished formulations upon request. The Dipyridamole suppliers may include Dipyridamole API manufacturers, exporters, distributors and traders.
click here to find a list of Dipyridamole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dipyridamole DMF (Drug Master File) is a document detailing the whole manufacturing process of Dipyridamole active pharmaceutical ingredient (API) in detail. Different forms of Dipyridamole DMFs exist exist since differing nations have different regulations, such as Dipyridamole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dipyridamole DMF submitted to regulatory agencies in the US is known as a USDMF. Dipyridamole USDMF includes data on Dipyridamole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dipyridamole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dipyridamole 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 Dipyridamole Drug Master File in Japan (Dipyridamole JDMF) empowers Dipyridamole 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 Dipyridamole JDMF during the approval evaluation for pharmaceutical products. At the time of Dipyridamole 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 Dipyridamole suppliers with JDMF on PharmaCompass.
A Dipyridamole CEP of the European Pharmacopoeia monograph is often referred to as a Dipyridamole Certificate of Suitability (COS). The purpose of a Dipyridamole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dipyridamole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dipyridamole to their clients by showing that a Dipyridamole CEP has been issued for it. The manufacturer submits a Dipyridamole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dipyridamole CEP holder for the record. Additionally, the data presented in the Dipyridamole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dipyridamole DMF.
A Dipyridamole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dipyridamole 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 Dipyridamole suppliers with CEP (COS) on PharmaCompass.
A Dipyridamole written confirmation (Dipyridamole WC) is an official document issued by a regulatory agency to a Dipyridamole manufacturer, verifying that the manufacturing facility of a Dipyridamole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dipyridamole APIs or Dipyridamole finished pharmaceutical products to another nation, regulatory agencies frequently require a Dipyridamole WC (written confirmation) as part of the regulatory process.
click here to find a list of Dipyridamole 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 Dipyridamole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dipyridamole 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 Dipyridamole 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 Dipyridamole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dipyridamole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dipyridamole suppliers with NDC on PharmaCompass.
Dipyridamole 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 Dipyridamole 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 Dipyridamole GMP manufacturer or Dipyridamole GMP API supplier for your needs.
A Dipyridamole CoA (Certificate of Analysis) is a formal document that attests to Dipyridamole's compliance with Dipyridamole specifications and serves as a tool for batch-level quality control.
Dipyridamole CoA mostly includes findings from lab analyses of a specific batch. For each Dipyridamole 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.
Dipyridamole may be tested according to a variety of international standards, such as European Pharmacopoeia (Dipyridamole EP), Dipyridamole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dipyridamole USP).
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