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Looking for 441798-33-0 / Macitentan API manufacturers, exporters & distributors?

Macitentan manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Macitentan

Synonyms

441798-33-0, Opsumit, Act-064992, Act 064992, N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-n'-propylsulfamide, Act064992

Cas Number

441798-33-0

Unique Ingredient Identifier (UNII)

Z9K9Y9WMVL

About Macitentan

Macitentan is an orally available dual endothelin receptor (ETR) antagonist with potential antihypertensive and antineoplastic activity. Upon administration, macitentan and its metabolites block the binding of endothelin isoform 1 (ET-1) to type-A and type-B ETR on both the tumor cells and the endothelial cells in the tumor vasculature. This prevents ET-1 mediated signaling transduction which may decrease tumor cell proliferation, progression, and angiogenesis in tumor tissue. ET-1, a potent vasoconstrictor that plays an important role in inflammation and tissue repair, is, together with its receptors, overexpressed varyingly in many tumor cell types.

Macitentan Manufacturers

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

Macitentan Suppliers

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

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

Macitentan USDMF

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

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

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

Macitentan KDMF

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

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

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

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

Macitentan WC

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

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

Macitentan 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 Macitentan as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Macitentan GMP

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

Macitentan CoA

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

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

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