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List of Drug Master Files (JDMF) for 01815_FLUKA Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 SIGMA-ALDRICH ISRAEL Ltd. (1)

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01 Dactinomycin USP (1)

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221MF10187
13 Kiryat Mada Street, Har Hotzvim ...
2017-02-13
2009-08-13
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Looking for 50-76-0 / Dactinomycin API manufacturers, exporters & distributors?

Dactinomycin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Dactinomycin

Synonyms

Actinomycin d, Actinomycin c1, Actinomycin iv, Cosmegen, Meractinomycin, 50-76-0

Cas Number

50-76-0

Unique Ingredient Identifier (UNII)

1CC1JFE158

About Dactinomycin

A compound composed of a two CYCLIC PEPTIDES attached to a phenoxazine that is derived from STREPTOMYCES parvullus. It binds to DNA and inhibits RNA synthesis (transcription), with chain elongation more sensitive than initiation, termination, or release. As a result of impaired mRNA production, protein synthesis also declines after dactinomycin therapy. (From AMA Drug Evaluations Annual, 1993, p2015)

01815_FLUKA Manufacturers

A 01815_FLUKA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 01815_FLUKA, including repackagers and relabelers. The FDA regulates 01815_FLUKA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 01815_FLUKA 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 01815_FLUKA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

01815_FLUKA Suppliers

A 01815_FLUKA supplier is an individual or a company that provides 01815_FLUKA active pharmaceutical ingredient (API) or 01815_FLUKA finished formulations upon request. The 01815_FLUKA suppliers may include 01815_FLUKA API manufacturers, exporters, distributors and traders.

click here to find a list of 01815_FLUKA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

01815_FLUKA 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 01815_FLUKA Drug Master File in Japan (01815_FLUKA JDMF) empowers 01815_FLUKA 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 01815_FLUKA JDMF during the approval evaluation for pharmaceutical products. At the time of 01815_FLUKA 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 01815_FLUKA suppliers with JDMF on PharmaCompass.

01815_FLUKA Manufacturers | Traders | Suppliers

01815_FLUKA Manufacturers, Traders, Suppliers 1
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We have 1 companies offering 01815_FLUKA

Get in contact with the supplier of your choice:

  1. SAFC
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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