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Looking for 150683-30-0 / Tolvaptan API manufacturers, exporters & distributors?

Tolvaptan manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Tolvaptan

Synonyms

150683-30-0, Samsca, Opc-41061, Opc 41061, N-(4-(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1h-benzo[b]azepine-1-carbonyl)-3-methylphenyl)-2-methylbenzamide, N-[4-(7-chloro-5-hydroxy-2,3,4,5-tetrahydro-1-benzazepine-1-carbonyl)-3-methylphenyl]-2-methylbenzamide

Cas Number

150683-30-0

Unique Ingredient Identifier (UNII)

21G72T1950

About Tolvaptan

A benzazepine derivative and selective VASOPRESSIN V2 RECEPTOR antagonist that is used to treat euvolemic and hypervolemic HYPONATREMIA. It is also used in the treatment of rapidly progressing AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE to slow the rate of cyst development and renal insufficiency.

Tolvaptan Manufacturers

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

Tolvaptan Suppliers

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

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

Tolvaptan USDMF

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

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

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

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

Tolvaptan KDMF

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

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

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

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

Tolvaptan WC

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

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

Tolvaptan 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 Tolvaptan as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Tolvaptan GMP

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

Tolvaptan CoA

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

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

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