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

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    Estetrol

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    01 GEDEON RICHTER Plc. (1)

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    01 Estetrol hydrate (1)

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    GEDEON RICHTER Plc.

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      Estetrol hydrate

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      305MF10111
      BUDAPEST, GYOMROI UT 19-21, HUNGARY
      2023-09-26
      2023-09-26
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      Looking for 15183-37-6 / Estetrol API manufacturers, exporters & distributors?

      Estetrol manufacturers, exporters & distributors 1

      98

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

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

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

      API | Excipient name

      Estetrol

      Synonyms

      15183-37-6, Estetrol anhydrous, 15.alpha.-hydroxyestriol, Enb39r14vf, (8r,9s,13s,14s,15r,16r,17r)-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthrene-3,15,16,17-tetrol, Estetrol (usan)

      Cas Number

      15183-37-6

      Unique Ingredient Identifier (UNII)

      ENB39R14VF

      About Estetrol

      A metabolite of ESTRIOL with a 15-alpha-hydroxyl group. Estetrol can be converted from estriol sulfate or DEHYDROEPIANDROSTERONE SULFATE by the fetal-placental unit.

      Estetrol Manufacturers

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

      Estetrol Suppliers

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

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

      Estetrol 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 Estetrol Drug Master File in Japan (Estetrol JDMF) empowers Estetrol 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 Estetrol JDMF during the approval evaluation for pharmaceutical products. At the time of Estetrol 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 Estetrol suppliers with JDMF on PharmaCompass.

      Estetrol Manufacturers | Traders | Suppliers

      Estetrol Manufacturers, Traders, Suppliers 1
      73

      We have 1 companies offering Estetrol

      Get in contact with the supplier of your choice:

      1. Gedeon Richter
      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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