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

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    Scopolamine

    APIs // Active Pharmaceutical Ingredients

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    01 Phytex Australia Pty Ltd (1)

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    Phytex Australia

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    Scopolamine

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    Masung LS Co., Ltd.
    2022-05-06
    20220506-211-J-1287
    Phytex Australia Pty Ltd
    Australia
    6 Norman Street Peakhurst...
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    Looking for 51-34-3 / Scopolamine API manufacturers, exporters & distributors?

    Scopolamine manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Scopolamine

    Synonyms

    Hyoscine, (-)-hyoscine, 51-34-3, Scopine (-)-tropate, Scopine tropate, (-)-scopolamine

    Cas Number

    51-34-3

    Unique Ingredient Identifier (UNII)

    DL48G20X8X

    About Scopolamine

    An alkaloid from SOLANACEAE, especially DATURA and SCOPOLIA. Scopolamine and its quaternary derivatives act as antimuscarinics like ATROPINE, but may have more central nervous system effects. Its many uses include an anesthetic premedication, the treatment of URINARY INCONTINENCE and MOTION SICKNESS, an antispasmodic, and a mydriatic and cycloplegic.

    Scopolamine Manufacturers

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

    Scopolamine Suppliers

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

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

    Scopolamine KDMF

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

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

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

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

    Scopolamine Manufacturers | Traders | Suppliers

    Scopolamine Manufacturers, Traders, Suppliers 1
    11

    We have 1 companies offering Scopolamine

    Get in contact with the supplier of your choice:

    1. Phytex Australia
    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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