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    List of Drug Master Files (KDMF) for Brexpiprazole Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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    Brexpiprazole

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    01 Honor Lab Limited (Unit III) (1)

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    HONOUR LAB LTD

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    Brexpiprazole

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    Leesung International Co., Ltd.
    2020-11-06
    20201106-211-J-780
    Honor Lab Limited (Unit I...
    India
    Plot No.4, Hetero Infrast...
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    Looking for 913611-97-9 / Brexpiprazole API manufacturers, exporters & distributors?

    Brexpiprazole manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Brexpiprazole

    Synonyms

    913611-97-9, Opc-34712, Rexulti, 7-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)quinolin-2(1h)-one, Opc 34712, 2j3ybm1k8c

    Cas Number

    913611-97-9

    Unique Ingredient Identifier (UNII)

    2J3YBM1K8C

    About Brexpiprazole

    Brexpiprazole is a novel D2 dopamine and serotonin 1A partial agonist, called serotonin-dopamine activity modulator (SDAM), and a potent antagonist of serotonin 2A receptors, noradrenergic alpha 1B and 2C receptors. Brexpiprazole is approved for the treatment of schizophrenia, and as an adjunctive treatment for major depressive disorder (MDD). Although it failed Phase II clinical trials for ADHD, it has been designed to provide improved efficacy and tolerability (e.g., less akathisia, restlessness and/or insomnia) over established adjunctive treatments for major depressive disorder (MDD).

    Brexpiprazole Manufacturers

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

    Brexpiprazole Suppliers

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

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

    Brexpiprazole KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Brexpiprazole Drug Master File in Korea (Brexpiprazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Brexpiprazole. The MFDS reviews the Brexpiprazole KDMF as part of the drug registration process and uses the information provided in the Brexpiprazole KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Brexpiprazole KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Brexpiprazole API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Brexpiprazole suppliers with KDMF on PharmaCompass.

    Brexpiprazole Manufacturers | Traders | Suppliers

    Brexpiprazole Manufacturers, Traders, Suppliers 1
    13

    We have 1 companies offering Brexpiprazole

    Get in contact with the supplier of your choice:

    1. HONOUR LAB LTD
    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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