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

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01 Pharma Mar, S. A. (1)

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01 Trabectedin (1)

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01 Spain (1)

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226MF10132
Avenida de los Reyes 1, P. I. La Mi...
2019-03-04
2014-07-02
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Looking for 114899-77-3 / Trabectedin API manufacturers, exporters & distributors?

Trabectedin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Trabectedin

Synonyms

Yondelis, Ecteinascidin, Ecteinascidin 743, Et-743, 114899-77-3, Ect 743

Cas Number

114899-77-3

Unique Ingredient Identifier (UNII)

ID0YZQ2TCP

About Trabectedin

A complex structure that includes isoquinolines joined by a cyclic ester; it is a DNA-binding agent and guanine N2 alkylator derived from the marine tunicate, Ecteinascidia turbinata. Trabectedin is used for the treatment of advanced soft-tissue SARCOMA, after failure of ANTHRACYCLINES or IFOSFAMIDE drug therapy.

Trabectedin Manufacturers

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

Trabectedin Suppliers

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

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

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

Trabectedin Manufacturers | Traders | Suppliers

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

Get in contact with the supplier of your choice:

  1. PharmaMar
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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