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List of Drug Master Files (JDMF) for Ondansetron HCl Dihydrate Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Dr. Reddy's Laboratories Ltd. (2)

02 Teva Pharmaceutical Works Private Limited Company (1)

03 Cambrex Charles City, Inc. (1)

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01 Ondansetron hydrochloride (1)

02 Ondansetron hydrochloride "Teva" (1)

03 Ondansetron hydrochloride hydrate (2)

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01 India (2)

02 Israel (1)

03 U.S.A (1)

URL Supplier Web Content
219MF10022
13 Pallagi u(´)t, Debrecen, 4042-H...
2017-05-16
2007-01-22
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URL Supplier Web Content
219MF10374
1205 11th Street, Charles City, Iow...
2007-12-19
2007-12-19
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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 JDMF

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.

Ondansetron HCl Dihydrate Manufacturers | Traders | Suppliers

Ondansetron HCl Dihydrate Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Ondansetron HCl Dihydrate

Get in contact with the supplier of your choice:

  1. Dr. Reddy's Laboratories
  2. Teva API
  3. Cambrex Corporation
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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