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PharmaCompass

01

The Generic Rx Session
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothInke S.A: APIs manufacturing plant.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16172

Submission : 2002-09-30

Status : Active

Type : II

Inke Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16320

Submission : 2003-01-29

Status : Active

Type : II

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16644

Submission : 2003-06-11

Status : Active

Type : II

TAPI Company Banner

04

The Generic Rx Session
Not Confirmed

05

The Generic Rx Session
Not Confirmed

05

The Generic Rx Session
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2021-08-17

Pay. Date : 2021-08-12

DMF Number : 18829

Submission : 2005-09-03

Status : Active

Type : II

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

Ondansetron manufacturers, exporters & distributors 1

46

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.

Ondansetron Manufacturers

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

Ondansetron Suppliers

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

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

Ondansetron USDMF

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

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

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

Ondansetron Manufacturers | Traders | Suppliers

Ondansetron 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.