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Looking for 147-94-4 / Cytarabine API manufacturers, exporters & distributors?

Cytarabine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Cytarabine

Synonyms

147-94-4, Ara-c, Cytosine arabinoside, Arabinocytidine, Aracytin, Depocyt

Cas Number

147-94-4

Unique Ingredient Identifier (UNII)

04079A1RDZ

About Cytarabine

A pyrimidine nucleoside analog that is used mainly in the treatment of leukemia, especially acute non-lymphoblastic leukemia. Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA. Its actions are specific for the S phase of the cell cycle. It also has antiviral and immunosuppressant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p472)

04079A1RDZ Manufacturers

A 04079A1RDZ manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 04079A1RDZ, including repackagers and relabelers. The FDA regulates 04079A1RDZ manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 04079A1RDZ 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 04079A1RDZ manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

04079A1RDZ Suppliers

A 04079A1RDZ supplier is an individual or a company that provides 04079A1RDZ active pharmaceutical ingredient (API) or 04079A1RDZ finished formulations upon request. The 04079A1RDZ suppliers may include 04079A1RDZ API manufacturers, exporters, distributors and traders.

click here to find a list of 04079A1RDZ suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

04079A1RDZ USDMF

A 04079A1RDZ DMF (Drug Master File) is a document detailing the whole manufacturing process of 04079A1RDZ active pharmaceutical ingredient (API) in detail. Different forms of 04079A1RDZ DMFs exist exist since differing nations have different regulations, such as 04079A1RDZ USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 04079A1RDZ DMF submitted to regulatory agencies in the US is known as a USDMF. 04079A1RDZ USDMF includes data on 04079A1RDZ's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 04079A1RDZ USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 04079A1RDZ suppliers with USDMF on PharmaCompass.

04079A1RDZ 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 04079A1RDZ Drug Master File in Japan (04079A1RDZ JDMF) empowers 04079A1RDZ 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 04079A1RDZ JDMF during the approval evaluation for pharmaceutical products. At the time of 04079A1RDZ 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 04079A1RDZ suppliers with JDMF on PharmaCompass.

04079A1RDZ KDMF

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

Pharmaceutical companies submit a 04079A1RDZ Drug Master File in Korea (04079A1RDZ KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 04079A1RDZ. The MFDS reviews the 04079A1RDZ KDMF as part of the drug registration process and uses the information provided in the 04079A1RDZ KDMF to evaluate the safety and efficacy of the drug.

After submitting a 04079A1RDZ 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 04079A1RDZ API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 04079A1RDZ suppliers with KDMF on PharmaCompass.

04079A1RDZ CEP

A 04079A1RDZ CEP of the European Pharmacopoeia monograph is often referred to as a 04079A1RDZ Certificate of Suitability (COS). The purpose of a 04079A1RDZ CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 04079A1RDZ EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 04079A1RDZ to their clients by showing that a 04079A1RDZ CEP has been issued for it. The manufacturer submits a 04079A1RDZ CEP (COS) as part of the market authorization procedure, and it takes on the role of a 04079A1RDZ CEP holder for the record. Additionally, the data presented in the 04079A1RDZ CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 04079A1RDZ DMF.

A 04079A1RDZ CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 04079A1RDZ CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of 04079A1RDZ suppliers with CEP (COS) on PharmaCompass.

04079A1RDZ WC

A 04079A1RDZ written confirmation (04079A1RDZ WC) is an official document issued by a regulatory agency to a 04079A1RDZ manufacturer, verifying that the manufacturing facility of a 04079A1RDZ active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 04079A1RDZ APIs or 04079A1RDZ finished pharmaceutical products to another nation, regulatory agencies frequently require a 04079A1RDZ WC (written confirmation) as part of the regulatory process.

click here to find a list of 04079A1RDZ suppliers with Written Confirmation (WC) on PharmaCompass.

04079A1RDZ 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 04079A1RDZ as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 04079A1RDZ 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 04079A1RDZ 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 04079A1RDZ and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 04079A1RDZ NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 04079A1RDZ suppliers with NDC on PharmaCompass.

04079A1RDZ GMP

04079A1RDZ 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 04079A1RDZ 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 04079A1RDZ GMP manufacturer or 04079A1RDZ GMP API supplier for your needs.

04079A1RDZ CoA

A 04079A1RDZ CoA (Certificate of Analysis) is a formal document that attests to 04079A1RDZ's compliance with 04079A1RDZ specifications and serves as a tool for batch-level quality control.

04079A1RDZ CoA mostly includes findings from lab analyses of a specific batch. For each 04079A1RDZ 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.

04079A1RDZ may be tested according to a variety of international standards, such as European Pharmacopoeia (04079A1RDZ EP), 04079A1RDZ JP (Japanese Pharmacopeia) and the US Pharmacopoeia (04079A1RDZ 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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