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Looking for 127-07-1 / Hydroxyurea API manufacturers, exporters & distributors?

Hydroxyurea manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Hydroxyurea

Synonyms

Hydroxycarbamide, 127-07-1, N-hydroxyurea, Hydrea, 1-hydroxyurea, Oxyurea

Cas Number

127-07-1

Unique Ingredient Identifier (UNII)

X6Q56QN5QC

About Hydroxyurea

An antineoplastic agent that inhibits DNA synthesis through the inhibition of ribonucleoside diphosphate reductase.

Tox21_300319 Manufacturers

A Tox21_300319 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tox21_300319, including repackagers and relabelers. The FDA regulates Tox21_300319 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tox21_300319 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 Tox21_300319 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Tox21_300319 Suppliers

A Tox21_300319 supplier is an individual or a company that provides Tox21_300319 active pharmaceutical ingredient (API) or Tox21_300319 finished formulations upon request. The Tox21_300319 suppliers may include Tox21_300319 API manufacturers, exporters, distributors and traders.

click here to find a list of Tox21_300319 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Tox21_300319 USDMF

A Tox21_300319 DMF (Drug Master File) is a document detailing the whole manufacturing process of Tox21_300319 active pharmaceutical ingredient (API) in detail. Different forms of Tox21_300319 DMFs exist exist since differing nations have different regulations, such as Tox21_300319 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Tox21_300319 DMF submitted to regulatory agencies in the US is known as a USDMF. Tox21_300319 USDMF includes data on Tox21_300319's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tox21_300319 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Tox21_300319 suppliers with USDMF on PharmaCompass.

Tox21_300319 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 Tox21_300319 Drug Master File in Japan (Tox21_300319 JDMF) empowers Tox21_300319 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 Tox21_300319 JDMF during the approval evaluation for pharmaceutical products. At the time of Tox21_300319 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 Tox21_300319 suppliers with JDMF on PharmaCompass.

Tox21_300319 CEP

A Tox21_300319 CEP of the European Pharmacopoeia monograph is often referred to as a Tox21_300319 Certificate of Suitability (COS). The purpose of a Tox21_300319 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tox21_300319 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tox21_300319 to their clients by showing that a Tox21_300319 CEP has been issued for it. The manufacturer submits a Tox21_300319 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tox21_300319 CEP holder for the record. Additionally, the data presented in the Tox21_300319 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tox21_300319 DMF.

A Tox21_300319 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tox21_300319 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 Tox21_300319 suppliers with CEP (COS) on PharmaCompass.

Tox21_300319 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 Tox21_300319 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Tox21_300319 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 Tox21_300319 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 Tox21_300319 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tox21_300319 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Tox21_300319 suppliers with NDC on PharmaCompass.

Tox21_300319 GMP

Tox21_300319 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 Tox21_300319 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 Tox21_300319 GMP manufacturer or Tox21_300319 GMP API supplier for your needs.

Tox21_300319 CoA

A Tox21_300319 CoA (Certificate of Analysis) is a formal document that attests to Tox21_300319's compliance with Tox21_300319 specifications and serves as a tool for batch-level quality control.

Tox21_300319 CoA mostly includes findings from lab analyses of a specific batch. For each Tox21_300319 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.

Tox21_300319 may be tested according to a variety of international standards, such as European Pharmacopoeia (Tox21_300319 EP), Tox21_300319 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tox21_300319 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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