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GDUFA

DMF Review : Complete

Rev. Date : 2016-12-02

Pay. Date : 2016-09-28

DMF Number : 29490

Submission : 2015-06-30

Status : Active

Type : II

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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.

Letairis Manufacturers

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

Letairis Suppliers

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

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

Letairis USDMF

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

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

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

Letairis Manufacturers | Traders | Suppliers

Letairis 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.