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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)

MolPort-001-792-509 Manufacturers

A MolPort-001-792-509 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MolPort-001-792-509, including repackagers and relabelers. The FDA regulates MolPort-001-792-509 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MolPort-001-792-509 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 MolPort-001-792-509 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

MolPort-001-792-509 Suppliers

A MolPort-001-792-509 supplier is an individual or a company that provides MolPort-001-792-509 active pharmaceutical ingredient (API) or MolPort-001-792-509 finished formulations upon request. The MolPort-001-792-509 suppliers may include MolPort-001-792-509 API manufacturers, exporters, distributors and traders.

click here to find a list of MolPort-001-792-509 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

MolPort-001-792-509 USDMF

A MolPort-001-792-509 DMF (Drug Master File) is a document detailing the whole manufacturing process of MolPort-001-792-509 active pharmaceutical ingredient (API) in detail. Different forms of MolPort-001-792-509 DMFs exist exist since differing nations have different regulations, such as MolPort-001-792-509 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A MolPort-001-792-509 DMF submitted to regulatory agencies in the US is known as a USDMF. MolPort-001-792-509 USDMF includes data on MolPort-001-792-509's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MolPort-001-792-509 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of MolPort-001-792-509 suppliers with USDMF on PharmaCompass.

MolPort-001-792-509 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 MolPort-001-792-509 Drug Master File in Japan (MolPort-001-792-509 JDMF) empowers MolPort-001-792-509 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 MolPort-001-792-509 JDMF during the approval evaluation for pharmaceutical products. At the time of MolPort-001-792-509 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 MolPort-001-792-509 suppliers with JDMF on PharmaCompass.

MolPort-001-792-509 KDMF

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

Pharmaceutical companies submit a MolPort-001-792-509 Drug Master File in Korea (MolPort-001-792-509 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MolPort-001-792-509. The MFDS reviews the MolPort-001-792-509 KDMF as part of the drug registration process and uses the information provided in the MolPort-001-792-509 KDMF to evaluate the safety and efficacy of the drug.

After submitting a MolPort-001-792-509 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 MolPort-001-792-509 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of MolPort-001-792-509 suppliers with KDMF on PharmaCompass.

MolPort-001-792-509 CEP

A MolPort-001-792-509 CEP of the European Pharmacopoeia monograph is often referred to as a MolPort-001-792-509 Certificate of Suitability (COS). The purpose of a MolPort-001-792-509 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MolPort-001-792-509 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MolPort-001-792-509 to their clients by showing that a MolPort-001-792-509 CEP has been issued for it. The manufacturer submits a MolPort-001-792-509 CEP (COS) as part of the market authorization procedure, and it takes on the role of a MolPort-001-792-509 CEP holder for the record. Additionally, the data presented in the MolPort-001-792-509 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MolPort-001-792-509 DMF.

A MolPort-001-792-509 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MolPort-001-792-509 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 MolPort-001-792-509 suppliers with CEP (COS) on PharmaCompass.

MolPort-001-792-509 WC

A MolPort-001-792-509 written confirmation (MolPort-001-792-509 WC) is an official document issued by a regulatory agency to a MolPort-001-792-509 manufacturer, verifying that the manufacturing facility of a MolPort-001-792-509 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting MolPort-001-792-509 APIs or MolPort-001-792-509 finished pharmaceutical products to another nation, regulatory agencies frequently require a MolPort-001-792-509 WC (written confirmation) as part of the regulatory process.

click here to find a list of MolPort-001-792-509 suppliers with Written Confirmation (WC) on PharmaCompass.

MolPort-001-792-509 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 MolPort-001-792-509 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for MolPort-001-792-509 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 MolPort-001-792-509 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 MolPort-001-792-509 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MolPort-001-792-509 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of MolPort-001-792-509 suppliers with NDC on PharmaCompass.

MolPort-001-792-509 GMP

MolPort-001-792-509 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 MolPort-001-792-509 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 MolPort-001-792-509 GMP manufacturer or MolPort-001-792-509 GMP API supplier for your needs.

MolPort-001-792-509 CoA

A MolPort-001-792-509 CoA (Certificate of Analysis) is a formal document that attests to MolPort-001-792-509's compliance with MolPort-001-792-509 specifications and serves as a tool for batch-level quality control.

MolPort-001-792-509 CoA mostly includes findings from lab analyses of a specific batch. For each MolPort-001-792-509 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.

MolPort-001-792-509 may be tested according to a variety of international standards, such as European Pharmacopoeia (MolPort-001-792-509 EP), MolPort-001-792-509 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MolPort-001-792-509 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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