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Looking for 58069-82-2 / Urea C13 API manufacturers, exporters & distributors?

Urea C13 manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Urea C13 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 Urea C13 manufacturer or Urea C13 supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Urea C13 manufacturer or Urea C13 supplier.

PharmaCompass also assists you with knowing the Urea C13 API Price utilized in the formulation of products. Urea C13 API Price is not always fixed or binding as the Urea C13 Price is obtained through a variety of data sources. The Urea C13 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Urea C13

Synonyms

Urea-13c, 58069-82-2, Urea c 13, 13c-urea, Urea, c-13, Carbon-13 urea

Cas Number

58069-82-2

Unique Ingredient Identifier (UNII)

W6KX9E6D8X

About Urea C13

Urea C-13 is a radiolabelled urea molecule used to diagnose stomach ulcers caused by Heliobacter pylori. In the presence of H. pylori, urea C-13 is metabolized by urease to produce ammonia and radioactive carbon dioxide at the interface between the gastric epithelium and lumen. The radioactive carbon dioxide is absorbed in the blood and is detected when exhaled in the breath.

UREA C-13 Manufacturers

A UREA C-13 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of UREA C-13, including repackagers and relabelers. The FDA regulates UREA C-13 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. UREA C-13 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

UREA C-13 Suppliers

A UREA C-13 supplier is an individual or a company that provides UREA C-13 active pharmaceutical ingredient (API) or UREA C-13 finished formulations upon request. The UREA C-13 suppliers may include UREA C-13 API manufacturers, exporters, distributors and traders.

click here to find a list of UREA C-13 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

UREA C-13 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 UREA C-13 Drug Master File in Japan (UREA C-13 JDMF) empowers UREA C-13 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 UREA C-13 JDMF during the approval evaluation for pharmaceutical products. At the time of UREA C-13 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 UREA C-13 suppliers with JDMF on PharmaCompass.

UREA C-13 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 UREA C-13 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for UREA C-13 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 UREA C-13 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 UREA C-13 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a UREA C-13 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of UREA C-13 suppliers with NDC on PharmaCompass.

UREA C-13 GMP

UREA C-13 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 UREA C-13 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 UREA C-13 GMP manufacturer or UREA C-13 GMP API supplier for your needs.

UREA C-13 CoA

A UREA C-13 CoA (Certificate of Analysis) is a formal document that attests to UREA C-13's compliance with UREA C-13 specifications and serves as a tool for batch-level quality control.

UREA C-13 CoA mostly includes findings from lab analyses of a specific batch. For each UREA C-13 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.

UREA C-13 may be tested according to a variety of international standards, such as European Pharmacopoeia (UREA C-13 EP), UREA C-13 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (UREA C-13 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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