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

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    Alsiodol (TN)

    APIs // Active Pharmaceutical Ingredients

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    DOSSIERs // Finished Dosage Forms

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    01 CARBOGEN AMCIS B.V. (1)

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    01 Sungjin Exim Co., Ltd. (1)

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    01 Alfacalcidol (1)

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    CARBOGEN AMCIS AG

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    Alfacalcidol

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    Sungjin Exim Co., Ltd.
    2023-03-23
    20230323-211-J-1462
    CARBOGEN AMCIS B.V.
    Netherlands
    Nieuweweg 2a, Veenendaal,...
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    Looking for 41294-56-8 / Alfacalcidol API manufacturers, exporters & distributors?

    Alfacalcidol manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Alfacalcidol

    Synonyms

    1-hydroxycholecalciferol, Alphacalcidol, 41294-56-8, 1alpha-hydroxyvitamin d3, Alfarol, Bondiol

    Cas Number

    41294-56-8

    Unique Ingredient Identifier (UNII)

    URQ2517572

    About Alfacalcidol

    Alfacalcidol, or 1-alpha-hydroxycholecalciferol or 1-alpha-hydroxyvitamin D3, is a non-endogenous analogue of [vitamin D]. It plays an essential function in calcium homeostasis and bone metabolism. Alfacaldisol is activated by the enzyme 25-hydroxylase in the liver to mediate its effects in the body, or most importantly, the kidneys and bones. The pharmacological actions of alfacalcidol are prolonged than vitamin D because a negative feedback mechanism regulates the final activation step of vitamin D in the kidneys. Alfacalcidol is available in oral and intravenous formulations. In Canada, it is marketed as ONE-ALPHA, which manages hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in adults with chronic renal failure. In approving European countries, alfacalcidol is also indicated for managing nutritional and malabsorptive rickets and osteomalacia, vitamin D-dependent rickets and osteomalacia, and hypophosphataemic vitamin D resistant rickets and osteomalacia.

    Alsiodol (TN) Manufacturers

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

    Alsiodol (TN) Suppliers

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

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

    Alsiodol (TN) KDMF

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

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

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

    click here to find a list of Alsiodol (TN) suppliers with KDMF on PharmaCompass.

    Alsiodol (TN) Manufacturers | Traders | Suppliers

    Alsiodol (TN) Manufacturers, Traders, Suppliers 1
    26

    We have 1 companies offering Alsiodol (TN)

    Get in contact with the supplier of your choice:

    1. CARBOGEN AMCIS AG
    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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