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