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

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01 Sicor Societa (') Italiana Corticosteroidi S. r. l. (1)

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01 Dexrazoxane "Teva" (1)

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01 Italy (1)

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224MF10205
Piazzale Luigi Cadorna, 4 - 20123 M...
2021-01-20
2012-10-09
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Looking for 1263283-43-7 / Dexrazoxane API manufacturers, exporters & distributors?

Dexrazoxane manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Dexrazoxane

Synonyms

149003-01-0, Dexrazoxane hcl, Totect, Cardioxane, Zinecard, Cardioxan

Cas Number

1263283-43-7

Unique Ingredient Identifier (UNII)

5346058Q7S

About Dexrazoxane

The (+)-enantiomorph of razoxane.

Dexrazoxane Manufacturers

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

Dexrazoxane Suppliers

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

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

Dexrazoxane 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 Dexrazoxane Drug Master File in Japan (Dexrazoxane JDMF) empowers Dexrazoxane 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 Dexrazoxane JDMF during the approval evaluation for pharmaceutical products. At the time of Dexrazoxane 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 Dexrazoxane suppliers with JDMF on PharmaCompass.

Dexrazoxane Manufacturers | Traders | Suppliers

Dexrazoxane Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Dexrazoxane

Get in contact with the supplier of your choice:

  1. Sicor Societa Italiana Corticosteroidi Srl
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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