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List of Drug Master Files (DMF) of Macitentan Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Alembic Pharmaceuticals Limited (1)

02 Aurobindo Pharma Limited (1)

03 HONOUR LAB LTD (1)

04 Laurus Labs (1)

05 MSN Laboratories (1)

06 Raks Pharma (1)

07 Teva API (1)

08 Viatris (1)

09 Zhejiang Guobang Pharmaceutical (1)

10 Zydus Lifesciences (1)

11 Blank (1)

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01 MACITENTAN (10)

02 MACITENTAN [ROUTE CODE IM] (1)

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01 China (1)

02 India (7)

03 Israel (1)

04 U.S.A (1)

05 Blank (1)

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01 Active (11)

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01 Complete (10)

02 Blank (1)

URL Supplier Web Content
31664
Active
2017-04-28
Complete
2017-07-05
2017-04-17
II
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URL Supplier Web Content
31749
Active
2017-05-15
Complete
2017-06-01
2017-05-12
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URL Supplier Web Content
31213
Active
2017-01-05
Complete
2017-02-27
2016-12-28
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URL Supplier Web Content
31957
Active
2017-09-15
Complete
2017-10-12
2017-08-30
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URL Supplier Web Content
30212
Active
2016-01-30
Complete
2016-12-22
2016-09-29
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URL Supplier Web Content
31179
Active
2016-12-13
Complete
2017-01-24
2016-12-05
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URL Supplier Web Content
31416
Active
2017-04-13
Complete
2017-05-03
2017-02-22
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URL Supplier Web Content
30969
Active
2016-09-30
Complete
2017-01-04
2016-09-27
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URL Supplier Web Content
31463
Active
2017-04-01
Complete
2017-05-10
2017-04-21
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SEASONS BIOTECHNOLOGY (TAIZHOU) CO ...

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URL Supplier Web Content
31658
Active
2017-05-31
Complete
2017-06-22
2017-06-05
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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 Manufacturers | Traders | Suppliers

Macitentan Manufacturers, Traders, Suppliers 1
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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