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List of Certificates of Suitability (CEPs) for Ondansetron HCl Dihydrate Active Pharmaceutical Ingredient issued by the EDQM and listed on PharmaCompass.com

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R1-CEP 2005-056 - Rev 00
Valid
Chemical
2012-05-24
2016
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R1-CEP 2004-066 - Rev 04
Valid
Chemical
2022-08-17
2016
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NA Not Available For Sales
R0-CEP 2009-191 - Rev 02
Expired
Chemical
2014-03-31
2016-02-05
2016
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R1-CEP 2009-114 - Rev 01
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Chemical
2023-05-04
2016
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CEP 2007-012 - Rev 06
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Chemical
2024-02-28
2016
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R1-CEP 2004-209 - Rev 03
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2020-03-04
2016
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R1-CEP 2003-130 - Rev 01
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2011-12-12
2016
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R1-CEP 2006-279 - Rev 03
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2014-07-28
2016
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R1-CEP 2003-053 - Rev 01
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2011-08-22
2016
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R1-CEP 2005-012 - Rev 05
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2022-09-07
2016
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R0-CEP 2017-185 - Rev 00
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2018-08-17
2023-08-31
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R1-CEP 2007-237 - Rev 02
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2019-09-18
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CEP 2003-221 - Rev 05
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2023-10-03
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R1-CEP 2008-174 - Rev 04
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2023-02-01
2016
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R1-CEP 2009-319 - Rev 04
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2019-09-16
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R0-CEP 2019-252 - Rev 00
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2021-12-06
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R1-CEP 2004-042 - Rev 03
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  • INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;ORAL - EQ 4MG BASE/5ML

Looking for 99614-01-4 / Ondansetron Hydrochloride API manufacturers, exporters & distributors?

Ondansetron Hydrochloride manufacturers, exporters & distributors 1

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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.

API | Excipient name

Ondansetron Hydrochloride

Synonyms

Ondansetron hcl, 99614-01-4, Zofran, Ondemet, Emeset, Ondansetron (hydrochloride)

Cas Number

99614-01-4

Unique Ingredient Identifier (UNII)

2999F27MAD

About Ondansetron Hydrochloride

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.

Ondansetron HCl Dihydrate Manufacturers

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.

Ondansetron HCl Dihydrate Suppliers

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.

Ondansetron HCl Dihydrate CEP

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.

Ondansetron HCl Dihydrate Manufacturers | Traders | Suppliers

Ondansetron HCl Dihydrate Manufacturers, Traders, Suppliers 1
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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