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    List of Berotralstat NDC API suppliers/manufacturers & exporters

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    Berotralstat

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    01 Berotralstat Dihydrochloride (1)

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    Cambrex Karlskoga AB

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    BEROTRALSTAT DIHYDROCHLORIDE

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    Berotralstat Dihydrochloride
    POWDER (1kg/kg)
    BULK INGREDIENT
    12651-120
    2021-01-13
    2024-12-31
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    Looking for 1809010-50-1 / Berotralstat API manufacturers, exporters & distributors?

    Berotralstat manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Berotralstat

    Synonyms

    1809010-50-1, Bcx7353, Berotralstat [inn], Berotralstat [usan], Xza0kb1bdq, Bcx-7353

    Cas Number

    1809010-50-1

    Unique Ingredient Identifier (UNII)

    XZA0KB1BDQ

    About Berotralstat

    Berotralstat is a selective inhibitor of plasma kallikrein used in the prophylaxis of attacks of hereditary angioedema (HAE). It works by blocking the enzymatic activity of plasma kallikrein in releasing bradykinin, the major biologic peptide that promotes swelling and pain associated with attacks of HAE. Developed by BioCryst Pharmaceuticals, berotralstat is taken once-daily as oral capsules. Under the market name Orladeyo, berotralstat was approved by the FDA on December 3, 2020, as the first oral, once-daily therapy to prevent angioedema attacks of HAE in adults and pediatric patients 12 years and older. In clinical trials, berotralstat was shown to significantly reduce attack rates at 24 weeks compared to placebo, which was sustained through 48 weeks. Berotralstat is strictly used to prevent, but not treat, these attacks. Previous oral therapies used for prophylaxis of HAE attacks, such as androgens, were limited by undesirable adverse effects and several contraindications. In clinical trials, berotralstat displayed a fast onset of action, long duration of action, and acceptable tolerance in patients.

    Berotralstat Manufacturers

    A Berotralstat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Berotralstat, including repackagers and relabelers. The FDA regulates Berotralstat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Berotralstat API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    Berotralstat Suppliers

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

    Berotralstat 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 Berotralstat as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Berotralstat Manufacturers | Traders | Suppliers

    Berotralstat Manufacturers, Traders, Suppliers 1
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    We have 1 companies offering Berotralstat

    Get in contact with the supplier of your choice:

    1. Cambrex Corporation
    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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