Synopsis
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CEP/COS
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JDMF
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VMF
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Canada
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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API Imports and Exports
Drugs in Development
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Global Sales Information
US Medicaid Prescriptions
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Granisetron 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 Granisetron manufacturer or Granisetron supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Granisetron manufacturer or Granisetron supplier.
PharmaCompass also assists you with knowing the Granisetron API Price utilized in the formulation of products. Granisetron API Price is not always fixed or binding as the Granisetron Price is obtained through a variety of data sources. The Granisetron Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Granisetron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Granisetron, including repackagers and relabelers. The FDA regulates Granisetron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Granisetron 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 Granisetron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Granisetron supplier is an individual or a company that provides Granisetron active pharmaceutical ingredient (API) or Granisetron finished formulations upon request. The Granisetron suppliers may include Granisetron API manufacturers, exporters, distributors and traders.
click here to find a list of Granisetron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Granisetron DMF (Drug Master File) is a document detailing the whole manufacturing process of Granisetron active pharmaceutical ingredient (API) in detail. Different forms of Granisetron DMFs exist exist since differing nations have different regulations, such as Granisetron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Granisetron DMF submitted to regulatory agencies in the US is known as a USDMF. Granisetron USDMF includes data on Granisetron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Granisetron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Granisetron suppliers with USDMF 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 Granisetron Drug Master File in Korea (Granisetron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Granisetron. The MFDS reviews the Granisetron KDMF as part of the drug registration process and uses the information provided in the Granisetron KDMF to evaluate the safety and efficacy of the drug.
After submitting a Granisetron 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 Granisetron API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Granisetron suppliers with KDMF on PharmaCompass.
A Granisetron written confirmation (Granisetron WC) is an official document issued by a regulatory agency to a Granisetron manufacturer, verifying that the manufacturing facility of a Granisetron active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Granisetron APIs or Granisetron finished pharmaceutical products to another nation, regulatory agencies frequently require a Granisetron WC (written confirmation) as part of the regulatory process.
click here to find a list of Granisetron 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 Granisetron as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Granisetron 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 Granisetron 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 Granisetron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Granisetron NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Granisetron suppliers with NDC on PharmaCompass.
Granisetron 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 Granisetron 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 Granisetron GMP manufacturer or Granisetron GMP API supplier for your needs.
A Granisetron CoA (Certificate of Analysis) is a formal document that attests to Granisetron's compliance with Granisetron specifications and serves as a tool for batch-level quality control.
Granisetron CoA mostly includes findings from lab analyses of a specific batch. For each Granisetron 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.
Granisetron may be tested according to a variety of international standards, such as European Pharmacopoeia (Granisetron EP), Granisetron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Granisetron USP).
