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Polpharma European CDMO Partner & API Manufacturer since 1951 Polpharma European CDMO Partner & API Manufacturer since 1951

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

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01 Medichem S.A (1)

02 Megafine Pharma (P) Limited (1)

03 Actavis Inc (1)

04 Cipla (1)

05 Jiangsu Joyglory Pharmaceutical (1)

06 MSN Laboratories (1)

07 Sun Pharmaceutical Industries Limited (1)

08 Tianjin Weijie Pharmaceutical Co., Ltd. (1)

09 Viatris (1)

10 Zhejiang Huahai Pharmaceutical (1)

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01 AMBRISENTAN (8)

02 AMBRISENTAN (MED-200028/M) (1)

03 AMBRISENTAN [ROUTE CODE - AB] (1)

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01 China (3)

02 India (4)

03 Ireland (1)

04 Spain (1)

05 U.S.A (1)

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01 Active (9)

02 Inactive (1)

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01 Complete (7)

02 Blank (3)

29792
Active
2015-09-09
Complete
2015-12-18
2015-09-28
II
Megafine Pharma CB

WBC 2024

Not Confirmed

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URL Supplier Web Content
25134
Inactive
2011-09-09
N/A
II
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29490
Active
2015-06-30
Complete
2016-12-02
2016-09-28
II
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30799
Active
2016-07-19
N/A
II
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26156
Active
2012-06-08
Complete
2015-12-18
2015-09-18
II
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36105
Active
2021-07-22
Complete
2021-09-02
2021-07-22
II
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31133
Active
2016-12-05
N/A
II
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24505
Active
2010-12-21
Complete
2014-10-20
2014-04-15
II
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27505
Active
2013-09-30
Complete
2014-05-23
2013-09-27
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Looking for 177036-94-1 / Ambrisentan API manufacturers, exporters & distributors?

Ambrisentan manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ambrisentan

Synonyms

177036-94-1, Letairis, Volibris, Lu-208075, Bsf 208075, Bsf-208075

Cas Number

177036-94-1

Unique Ingredient Identifier (UNII)

HW6NV07QEC

About Ambrisentan

Ambrisentan is an orally bioavailable, selective antagonist of the endothelin type-A (ETA) receptor that may be used for the treatment of pulmonary arterial hypertension (PAH). Upon administration, ambrisentan targets and binds to ETA receptor, which prevents the binding of endothelin-1 (ET-1) to the ETA receptor and ET-1/ETA-mediated vasoconstriction and cell proliferation. This may lead to vasodilation. ET-1 concentrations are increased in plasma as well as lung tissue in PAH, and ET-1 may play a key role in the pathogenesis of PAH.

Ambrisentan Manufacturers

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

Ambrisentan Suppliers

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

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

Ambrisentan USDMF

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

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

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

Ambrisentan Manufacturers | Traders | Suppliers

Ambrisentan 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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