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

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    Benzonatate

    APIs // Active Pharmaceutical Ingredients

    PRICE INFORMATION

    DOSSIERs // Finished Dosage Forms

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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 Formosa Laboratories, Inc. (1)

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    01 Hiple Co., Ltd. (1)

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    Formosa Laboratories

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    Benzonatate

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    Hiple Co., Ltd.
    2022-05-03
    20220503-209-J-1282
    Formosa Laboratories, Inc...
    Taiwan
    36 Hoping Street, Louchu,...
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    Looking for 104-31-4 / Benzonatate API manufacturers, exporters & distributors?

    Benzonatate manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Benzonatate

    Synonyms

    104-31-4, Benzononatine, Tessalon, Benzononantin, Exangit, Ventussin

    Cas Number

    104-31-4

    About Benzonatate

    Benzonatate is an oral antitussive drug used in the relief and suppression of cough in patients older than ten years of age. Currently, benzonatate is the only non-narcotic antitussive available as a prescription drug. It works to reduce the activity of cough reflex by desensitizing the tissues of the lungs and pleura involved in the cough reflex. Benzonatate was approved by the FDA in 1958 under the market name Tessalon Perles. Because its chemical structure resembles that of the anesthetic agents in the para-amino-benzoic acid class (such as [procaine] and [tetracaine]), benzonatate exhibits anesthetic or numbing action. Although it not prone to drug misuse or abuse, benzonatate is associated with a risk for severe toxicity and overdose, especially in children.

    Benzonatate Manufacturers

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

    Benzonatate Suppliers

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

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

    Benzonatate KDMF

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

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

    After submitting a Benzonatate 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 Benzonatate API can apply through the Korea Drug Master File (KDMF).

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

    Benzonatate Manufacturers | Traders | Suppliers

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

    Get in contact with the supplier of your choice:

    1. Formosa Laboratories
    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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