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

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    Dutetrabenazine

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    01 Teva API (1)

    02 Aurobindo Pharma Limited (1)

    03 Farmhispania (1)

    04 Hetero Drugs (1)

    05 Lupin Ltd (1)

    06 Maithri Drugs (1)

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    01 DEUTETRABENAZINE (5)

    02 SD-809 DEUTETRABENAZINE (1)

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    01 India (4)

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    TEVA PHARMACEUTICAL INDUSTRIES LTD

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    SD-809 DEUTETRABENAZINE

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    33849
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    2019-12-26
    N/A
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    APITORIA PHARMA PRIVATE LTD

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    DEUTETRABENAZINE

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    35247
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    2020-09-29
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    2020-11-12
    2020-09-28
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    FARMHISPANIA SA

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    DEUTETRABENAZINE

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    37341
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    2022-08-02
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    HETERO DRUGS LTD

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    DEUTETRABENAZINE

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    35197
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    2020-11-18
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    2021-01-14
    2020-11-19
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    LUPIN LTD

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    DEUTETRABENAZINE

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    35381
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    2020-12-25
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    2021-02-08
    2020-12-30
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    MAITHRI DRUGS PRIVATE LTD

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      DEUTETRABENAZINE

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      35158
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      2020-08-31
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      Looking for 1392826-25-3 / Deutetrabenazine API manufacturers, exporters & distributors?

      Deutetrabenazine manufacturers, exporters & distributors 1

      82

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

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

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

      API | Excipient name

      Deutetrabenazine

      Synonyms

      Dutetrabenazine, P341g6w9nb, Sd-809, (3rs,11brs)-9,10-di((2h3)methoxy)-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2h-benzo(a)quinolizin-2-one, 2h-benzo(a)quinolizin-2-one, 1,3,4,6,7,11b-hexahydro-9,10-di(methoxy-d3)-3-(2-methylpropyl)-, (3r,11br)-rel-, Sd809

      Cas Number

      1392826-25-3

      Unique Ingredient Identifier (UNII)

      P341G6W9NB

      About Deutetrabenazine

      Deutetrabenazine is a novel, highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the management of chorea associated with Huntingtons disease. It is a hexahydro-dimethoxybenzoquinolizine derivative and a deuterated [DB04844]. The presence of deuterium in deutetrabenazine increases the half-lives of the active metabolite and prolongs their pharmacological activity by attenuating CYP2D6 metabolism of the compound. This allows less frequent dosing and a lower daily dose with improvement in tolerability. Decreased plasma fluctuations of deutetrabenazine due to attenuated metabolism may explain a lower incidence of adverse reactions associated with deutetrabenazine. Deutetrabenazine is a racemic mixture containing RR-Deutetrabenazine and SS-Deutetrabenazine. Huntington's disease (HD) is a hereditary, progressive neurodegenerative disorder characterized by motor dysfunction, cognitive decline, and neuropsychiatric disturbances that interfere with daily functioning and significantly reduce the quality of life. The most prominent physical symptom of HD that may increase the risk of injury is chorea, which is an involuntary, sudden movement that can affect any muscle and flow randomly across body regions. Psychomotor symptoms of HD, such as chorea, are related to hyperactive dopaminergic neurotransmission. Deutetrabenazine depletes the levels of presynaptic dopamine by blocking VMAT2, which is responsible for the uptake of dopamine into synaptic vesicles in monoaminergic neurons and exocytotic release. As with other agents for the treatment of neurodegenerative diseases, deutetrabenazine is a drug to alleviate the motor symptoms of HD and is not proposed to halt the progression of the disease. In clinical trials of patients with HD, 12 weeks of treatment of deutetrabenazine resulted in overall improvement in mean total maximal chorea scores and motor signs than placebo. It was approved by FDA in April 2017 and is marketed under the trade name Austedo as oral tablets.

      Dutetrabenazine Manufacturers

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

      Dutetrabenazine Suppliers

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

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

      Dutetrabenazine USDMF

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

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

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

      Dutetrabenazine Manufacturers | Traders | Suppliers

      Dutetrabenazine Manufacturers, Traders, Suppliers 1
      85

      We have 6 companies offering Dutetrabenazine

      Get in contact with the supplier of your choice:

      1. Teva API
      2. Aurobindo Pharma Limited
      3. Farmhispania
      4. Hetero Drugs
      5. Lupin Ltd
      6. Maithri Drugs
      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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