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

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    Finerenone

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    Bayer AG

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    Bayer Korea Co., Ltd.
    2022-05-10
    Wed212-9-ND
    Bayer AG@Bayer AG@Bayer A...
    Germany
    Friedrich-Ebert-Str. 217-...
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    Looking for 1050477-31-0 / Finerenone API manufacturers, exporters & distributors?

    Finerenone manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Finerenone

    Synonyms

    1050477-31-0, Kerendia, Bay 94-8862, Bay94-8862, Finerenone (bay 94-8862), (4s)-4-(4-cyano-2-methoxyphenyl)-5-ethoxy-2,8-dimethyl-1,4-dihydro-1,6-naphthyridine-3-carboxamide

    Cas Number

    1050477-31-0

    Unique Ingredient Identifier (UNII)

    DE2O63YV8R

    About Finerenone

    Finerenone, or BAY 94-8862, is a mineralocorticoid receptor antagonist indicated to reduce the risk of sustained decline in glomerular filtration rate, end stage kidney disease, cardiovascular death, heart attacks, and hospitalization due to heart failure in adults with chronic kidney disease associated with type II diabetes mellitus. Patients with kidney disease, would originally be given [spironolactone] or [eplerenone] to antagonize the mineraclocorticoid receptor. Spironolactone has low selectivity and affinity for the receptor; it dissociates quickly and can also have effects at the androgen, progesterone, and glucocorticoid receptors. Eplerenone is more selective and has longer lasting effects. More selective nonsteroidal mineralocorticoid antagonists such as [apararenone], [esaxerenone], and finerenone were later developed. So far, finerenone is the only nonsteroidal mineralocorticoid receptor antagonist to be FDA approved. Finerenone was granted FDA approval on 9 July 2021.

    Finerenone Manufacturers

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

    Finerenone Suppliers

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

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

    Finerenone KDMF

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

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

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

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

    Finerenone Manufacturers | Traders | Suppliers

    Finerenone Manufacturers, Traders, Suppliers 1
    43

    We have 1 companies offering Finerenone

    Get in contact with the supplier of your choice:

    1. Bayer 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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