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List of Drug Master Files (DMF) of Lurbinectedin Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 BrightGene Bio-Medical Technology Co.,Ltd (1)

02 PharmaMar (1)

03 Wisdom Pharmaceutical Co., Ltd. (1)

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01 LURBINECTEDIN (3)

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01 China (2)

02 Spain (1)

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01 Active (3)

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01 Blank (3)

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39228
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2023-12-28
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33969
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2019-10-25
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URL Supplier Web Content
37624
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2023-01-18
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Looking for 497871-47-3 / Lurbinectedin API manufacturers, exporters & distributors?

Lurbinectedin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Lurbinectedin

Synonyms

497871-47-3, Pm01183, Tryptamicidin, Zepzelca, Pm-01183, Pm-1183

Cas Number

497871-47-3

Unique Ingredient Identifier (UNII)

2CN60TN6ZS

About Lurbinectedin

Lurbinectedin is a synthetic tetrahydropyrrolo [4, 3, 2-de]quinolin-8(1H)-one alkaloid analogue with potential antineoplastic activity. Lurbinectedin covalently binds to residues lying in the minor groove of DNA, which may result in delayed progression through S phase, cell cycle arrest in the G2/M phase and cell death.

Lurbinectedin Manufacturers

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

Lurbinectedin Suppliers

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

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

Lurbinectedin USDMF

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

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

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

Lurbinectedin Manufacturers | Traders | Suppliers

Lurbinectedin Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Lurbinectedin

Get in contact with the supplier of your choice:

  1. BrightGene Bio-Medical Technology Co.,Ltd
  2. PharmaMar
  3. Wisdom Pharmaceutical Co., Ltd.
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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