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

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    Tasimelteon

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    01 Apotex Pharmachem (1)

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    APOTEX PHARMACHEM INC

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    TASIMELTEON

    PDF Supplier PDF
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    31843
    Active
    2017-07-31
    Complete
    2017-10-30
    2017-07-26
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    MSN LIFE SCIENCES PRIVATE LTD

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    TASIMELTEON

    PDF Supplier PDF
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    31948
    Active
    2017-08-30
    Complete
    2017-10-05
    2017-09-22
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    ZHEJIANG AUSUN PHARMACEUTICAL CO LT...

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    TASIMELTEON

    PDF Supplier PDF
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    32077
    Active
    2017-11-07
    Complete
    2018-01-18
    2017-09-20
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    Looking for 609799-22-6 / Tasimelteon API manufacturers, exporters & distributors?

    Tasimelteon manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Tasimelteon

    Synonyms

    609799-22-6, Hetlioz, Vec-162, Bms-214778, Vec 162, Bms 214778

    Cas Number

    609799-22-6

    Unique Ingredient Identifier (UNII)

    SHS4PU80D9

    About Tasimelteon

    Tasimelteon is a selective dual melatonin receptor agonist indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (N24HSWD). Occurring commonly in blind individuals without light perception, this condition is often characterized by periods of night-time insomnia and day-time sleepiness. In blind individuals, a lack of light stimulation causes an extension of the 24-hour circadian cycle and can lead to progressively delayed sleep onset. By activating melatonin receptors MT1 and MT2 in the suprachiasmatic nucleus of the brain, tasimelteon has been shown to improve sleep by resynchronizing the circadian rhythm through its "non-photic" mechanism. Tasimelteon is currently the only drug available for the treatment of N24HSWD and was granted orphan drug status by the FDA in 2010.

    Tasimelteon Manufacturers

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

    Tasimelteon Suppliers

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

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

    Tasimelteon USDMF

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

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

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

    Tasimelteon Manufacturers | Traders | Suppliers

    Tasimelteon Manufacturers, Traders, Suppliers 1
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    We have 3 companies offering Tasimelteon

    Get in contact with the supplier of your choice:

    1. Apotex Pharmachem
    2. MSN Laboratories
    3. Zhejiang Ausun Pharmaceutical
    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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