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Looking for 1374248-77-7 / Ubrogepant API manufacturers, exporters & distributors?

Ubrogepant manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ubrogepant

Synonyms

1374248-77-7, Ubrelvy, Mk-1602, Ubrogepant anhydrous, Ad0o8x2qjr, (3's)-n-((3s,5s,6r)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro(cyclopenta(b)pyridine-6,3'-pyrrolo(2,3-b)pyridine)-3-carboxamide

Cas Number

1374248-77-7

Unique Ingredient Identifier (UNII)

AD0O8X2QJR

About Ubrogepant

Ubrogepant is indicated for the acute treatment of migraine headaches with or without aura in adults. It was approved by the FDA on December 23, 2019, and is the first oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine. Several oral small molecule CGRP receptor antagonists, belonging to a class of medications referred to as "gepants", have been investigated for migraines, but only ubrogepant and [rimegepant] remain in clinical development. Previous agents within this class were efficacious but limited by liver toxicity - this led to the development of ubrogepant, which was designed to be a hepatoxicity-free alternative to its predecessors. Several parenteral monoclonal antibodies acting against the CGRP pathway (e.g. [erenumab], [fremanezumab], [galcanezumab]) have also been approved in recent years. Compared to the current standard of therapy for migraine treatment, namely triptans such as [sumatriptan] and [almotriptan], CGRP antagonists present several advantages. They appear to be better tolerated, do not contribute to medication overuse headaches, and carry no apparent cardiovascular risk, making them suitable for use in patients with cardiovascular disease. The development of oral gepants, including ubrogepant, may therefore constitute a significant advance in migraine headache treatment and may become the new standard of therapy in the treatment of this debilitating condition.

Ubrogepant Manufacturers

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

Ubrogepant Suppliers

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

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

Ubrogepant USDMF

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

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

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

Ubrogepant 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 Ubrogepant as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Ubrogepant GMP

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

Ubrogepant CoA

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

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

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