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    List of Drug Master Files (JDMF) for Bepridil Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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    Bepridil

    APIs // Active Pharmaceutical Ingredients

    DOSSIERs // Finished Dosage Forms

    ANALYTICAL SOLUTION(s)

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    01 Shiono Finesse Co., Ltd. (1)

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    01 bepridil hydrochloride hydrate (1)

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    01 Japan (1)

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    Shiono Finesse Co., Ltd.

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      Bepridil hydrochloride hydrate

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      304MF10114
      3-1-6 Doshomachi, Chuo-ku, Osaka-sh...
      2022-08-03
      2022-08-03
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      Looking for 68099-86-5 / Bepridil API manufacturers, exporters & distributors?

      Bepridil manufacturers, exporters & distributors 1

      96

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

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

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

      API | Excipient name

      Bepridil

      Synonyms

      68099-86-5, Bepridil hcl, Cerm 1978, 1-isobutoxy-2-pyrrolidino-3-(n-benzylanilino)propane hydrochloride, 2tn7ff3w4m, Mls000028456

      Cas Number

      68099-86-5

      Unique Ingredient Identifier (UNII)

      2TN7FF3W4M

      About Bepridil

      A long-acting calcium-blocking agent with significant anti-anginal activity. The drug produces significant coronary vasodilation and modest peripheral effects. It has antihypertensive and selective anti-arrhythmia activities and acts as a calmodulin antagonist.

      Bepridil Manufacturers

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

      Bepridil Suppliers

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

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

      Bepridil JDMF

      The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

      The Bepridil Drug Master File in Japan (Bepridil JDMF) empowers Bepridil API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

      PMDA reviews the Bepridil JDMF during the approval evaluation for pharmaceutical products. At the time of Bepridil JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

      click here to find a list of Bepridil suppliers with JDMF on PharmaCompass.

      Bepridil Manufacturers | Traders | Suppliers

      Bepridil Manufacturers, Traders, Suppliers 1
      56

      We have 1 companies offering Bepridil

      Get in contact with the supplier of your choice:

      1. Shiono Finesse
      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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