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Looking for 50-44-2 / Mercaptopurine API manufacturers, exporters & distributors?

Mercaptopurine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Mercaptopurine

Synonyms

6-mercaptopurine, 50-44-2, Purinethol, Mercapurin, 6-thiopurine, Leukerin

Cas Number

50-44-2

Unique Ingredient Identifier (UNII)

PKK6MUZ20G

About Mercaptopurine

An antimetabolite antineoplastic agent with immunosuppressant properties. It interferes with nucleic acid synthesis by inhibiting purine metabolism and is used, usually in combination with other drugs, in the treatment of or in remission maintenance programs for leukemia.

Purinethol Manufacturers

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

Purinethol Suppliers

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

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

Purinethol USDMF

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

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

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

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

Purinethol KDMF

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

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

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

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

Purinethol CEP

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

A Purinethol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Purinethol 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 Purinethol suppliers with CEP (COS) on PharmaCompass.

Purinethol WC

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

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

Purinethol 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 Purinethol as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Purinethol GMP

Purinethol 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 Purinethol 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 Purinethol GMP manufacturer or Purinethol GMP API supplier for your needs.

Purinethol CoA

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

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

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