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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 USDMF

A 01815_FLUKA DMF (Drug Master File) is a document detailing the whole manufacturing process of 01815_FLUKA active pharmaceutical ingredient (API) in detail. Different forms of 01815_FLUKA DMFs exist exist since differing nations have different regulations, such as 01815_FLUKA USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 01815_FLUKA DMF submitted to regulatory agencies in the US is known as a USDMF. 01815_FLUKA USDMF includes data on 01815_FLUKA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 01815_FLUKA USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 01815_FLUKA suppliers with USDMF 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 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a 01815_FLUKA Drug Master File in Korea (01815_FLUKA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 01815_FLUKA. The MFDS reviews the 01815_FLUKA KDMF as part of the drug registration process and uses the information provided in the 01815_FLUKA KDMF to evaluate the safety and efficacy of the drug.

After submitting a 01815_FLUKA KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their 01815_FLUKA API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 01815_FLUKA suppliers with KDMF on PharmaCompass.

01815_FLUKA WC

A 01815_FLUKA written confirmation (01815_FLUKA WC) is an official document issued by a regulatory agency to a 01815_FLUKA manufacturer, verifying that the manufacturing facility of a 01815_FLUKA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 01815_FLUKA APIs or 01815_FLUKA finished pharmaceutical products to another nation, regulatory agencies frequently require a 01815_FLUKA WC (written confirmation) as part of the regulatory process.

click here to find a list of 01815_FLUKA suppliers with Written Confirmation (WC) on PharmaCompass.

01815_FLUKA NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing 01815_FLUKA as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 01815_FLUKA API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture 01815_FLUKA as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain 01815_FLUKA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 01815_FLUKA NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 01815_FLUKA suppliers with NDC on PharmaCompass.

01815_FLUKA GMP

01815_FLUKA Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of 01815_FLUKA GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right 01815_FLUKA GMP manufacturer or 01815_FLUKA GMP API supplier for your needs.

01815_FLUKA CoA

A 01815_FLUKA CoA (Certificate of Analysis) is a formal document that attests to 01815_FLUKA's compliance with 01815_FLUKA specifications and serves as a tool for batch-level quality control.

01815_FLUKA CoA mostly includes findings from lab analyses of a specific batch. For each 01815_FLUKA CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

01815_FLUKA may be tested according to a variety of international standards, such as European Pharmacopoeia (01815_FLUKA EP), 01815_FLUKA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (01815_FLUKA USP).

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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