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  • TABLET, ORALLY DISINTEGRATING;ORAL - 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, ORALLY DISINTEGRATING;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FILM;ORAL - 4MG
  • FILM;ORAL - 8MG

Looking for 99614-02-5 / Ondansetron API manufacturers, exporters & distributors?

Ondansetron manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Ondansetron 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 manufacturer or Ondansetron supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ondansetron manufacturer or Ondansetron supplier.

PharmaCompass also assists you with knowing the Ondansetron API Price utilized in the formulation of products. Ondansetron API Price is not always fixed or binding as the Ondansetron Price is obtained through a variety of data sources. The Ondansetron Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Ondansetron

Synonyms

99614-02-5, Zofran, Zudan, 9-methyl-3-((2-methyl-1h-imidazol-1-yl)methyl)-2,3-dihydro-1h-carbazol-4(9h)-one, Zofran odt, Zuplenz

Cas Number

99614-02-5

Unique Ingredient Identifier (UNII)

4AF302ESOS

About Ondansetron

A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.

DSSTox_CID_3393 Manufacturers

A DSSTox_CID_3393 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSSTox_CID_3393, including repackagers and relabelers. The FDA regulates DSSTox_CID_3393 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSSTox_CID_3393 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 DSSTox_CID_3393 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

DSSTox_CID_3393 Suppliers

A DSSTox_CID_3393 supplier is an individual or a company that provides DSSTox_CID_3393 active pharmaceutical ingredient (API) or DSSTox_CID_3393 finished formulations upon request. The DSSTox_CID_3393 suppliers may include DSSTox_CID_3393 API manufacturers, exporters, distributors and traders.

click here to find a list of DSSTox_CID_3393 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

DSSTox_CID_3393 USDMF

A DSSTox_CID_3393 DMF (Drug Master File) is a document detailing the whole manufacturing process of DSSTox_CID_3393 active pharmaceutical ingredient (API) in detail. Different forms of DSSTox_CID_3393 DMFs exist exist since differing nations have different regulations, such as DSSTox_CID_3393 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A DSSTox_CID_3393 DMF submitted to regulatory agencies in the US is known as a USDMF. DSSTox_CID_3393 USDMF includes data on DSSTox_CID_3393's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSSTox_CID_3393 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of DSSTox_CID_3393 suppliers with USDMF on PharmaCompass.

DSSTox_CID_3393 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a DSSTox_CID_3393 Drug Master File in Korea (DSSTox_CID_3393 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DSSTox_CID_3393. The MFDS reviews the DSSTox_CID_3393 KDMF as part of the drug registration process and uses the information provided in the DSSTox_CID_3393 KDMF to evaluate the safety and efficacy of the drug.

After submitting a DSSTox_CID_3393 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 DSSTox_CID_3393 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of DSSTox_CID_3393 suppliers with KDMF on PharmaCompass.

DSSTox_CID_3393 WC

A DSSTox_CID_3393 written confirmation (DSSTox_CID_3393 WC) is an official document issued by a regulatory agency to a DSSTox_CID_3393 manufacturer, verifying that the manufacturing facility of a DSSTox_CID_3393 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DSSTox_CID_3393 APIs or DSSTox_CID_3393 finished pharmaceutical products to another nation, regulatory agencies frequently require a DSSTox_CID_3393 WC (written confirmation) as part of the regulatory process.

click here to find a list of DSSTox_CID_3393 suppliers with Written Confirmation (WC) on PharmaCompass.

DSSTox_CID_3393 NDC

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 DSSTox_CID_3393 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for DSSTox_CID_3393 API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 DSSTox_CID_3393 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain DSSTox_CID_3393 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DSSTox_CID_3393 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of DSSTox_CID_3393 suppliers with NDC on PharmaCompass.

DSSTox_CID_3393 GMP

DSSTox_CID_3393 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 DSSTox_CID_3393 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 DSSTox_CID_3393 GMP manufacturer or DSSTox_CID_3393 GMP API supplier for your needs.

DSSTox_CID_3393 CoA

A DSSTox_CID_3393 CoA (Certificate of Analysis) is a formal document that attests to DSSTox_CID_3393's compliance with DSSTox_CID_3393 specifications and serves as a tool for batch-level quality control.

DSSTox_CID_3393 CoA mostly includes findings from lab analyses of a specific batch. For each DSSTox_CID_3393 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.

DSSTox_CID_3393 may be tested according to a variety of international standards, such as European Pharmacopoeia (DSSTox_CID_3393 EP), DSSTox_CID_3393 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DSSTox_CID_3393 USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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