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Looking for 1369764-02-2 / Lemborexant API manufacturers, exporters & distributors?

Lemborexant manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Lemborexant

Synonyms

1369764-02-2, Dayvigo, E-2006, E2006, 0k5743g68x, (1r,2s)-2-[(2,4-dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)-n-(5-fluoropyridin-2-yl)cyclopropane-1-carboxamide

Cas Number

1369764-02-2

Unique Ingredient Identifier (UNII)

0K5743G68X

About Lemborexant

Lemborexant is a novel dual orexin receptor antagonist used in the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Recent research in the field of sleep disorders has revealed that insomnia is likely driven not by the inability of the brain to "switch on" sleep-related circuits, but rather an inability to "switch-off" wake-promoting circuits. Whereas historically popular pharmacologic treatments for insomnia (e.g. [zopiclone], [zolpidem], benzodiazepines) focus on enhancing sleep drive via modulation of GABA and melatonin receptors, lemborexant and other orexin antagonists (e.g. [suvorexant]) act to counteract inappropriate wakefulness. This novel mechanism of action offers potential advantages over classic hypnotic agents, including a more favorable adverse effect profile and potentially greater efficacy, and may signal the beginning of a new wave of treatment options for patients suffering from insomnia.

Lemborexant Manufacturers

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

Lemborexant Suppliers

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

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

Lemborexant USDMF

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

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

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

Lemborexant GMP

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

Lemborexant CoA

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

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

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