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USDMF
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DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 20623
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 20623
DOSAGE - INJECTABLE;INJECTION - 100MG/5ML (20...DOSAGE - INJECTABLE;INJECTION - 100MG/5ML (20MG/ML)
USFDA APPLICATION NUMBER - 20624
DOSAGE - INJECTABLE;INJECTION - 12.5MG/0.625M...DOSAGE - INJECTABLE;INJECTION - 12.5MG/0.625ML (20MG/ML)
USFDA APPLICATION NUMBER - 20624
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ABOUT THIS PAGE
A Dolasetron Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dolasetron Mesylate, including repackagers and relabelers. The FDA regulates Dolasetron Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dolasetron Mesylate 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 Dolasetron Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dolasetron Mesylate supplier is an individual or a company that provides Dolasetron Mesylate active pharmaceutical ingredient (API) or Dolasetron Mesylate finished formulations upon request. The Dolasetron Mesylate suppliers may include Dolasetron Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Dolasetron Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dolasetron Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dolasetron Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Dolasetron Mesylate DMFs exist exist since differing nations have different regulations, such as Dolasetron Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dolasetron Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Dolasetron Mesylate USDMF includes data on Dolasetron Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dolasetron Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dolasetron Mesylate suppliers with USDMF on PharmaCompass.
A Dolasetron Mesylate written confirmation (Dolasetron Mesylate WC) is an official document issued by a regulatory agency to a Dolasetron Mesylate manufacturer, verifying that the manufacturing facility of a Dolasetron Mesylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dolasetron Mesylate APIs or Dolasetron Mesylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Dolasetron Mesylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Dolasetron Mesylate 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 Dolasetron Mesylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dolasetron Mesylate 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 Dolasetron Mesylate 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 Dolasetron Mesylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dolasetron Mesylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dolasetron Mesylate suppliers with NDC on PharmaCompass.
Dolasetron Mesylate 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 Dolasetron Mesylate 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 Dolasetron Mesylate GMP manufacturer or Dolasetron Mesylate GMP API supplier for your needs.
A Dolasetron Mesylate CoA (Certificate of Analysis) is a formal document that attests to Dolasetron Mesylate's compliance with Dolasetron Mesylate specifications and serves as a tool for batch-level quality control.
Dolasetron Mesylate CoA mostly includes findings from lab analyses of a specific batch. For each Dolasetron Mesylate 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.
Dolasetron Mesylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Dolasetron Mesylate EP), Dolasetron Mesylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dolasetron Mesylate USP).
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