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