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    List of Drug Master Files (DMF) of Etelcalcetide Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Etelcalcetide

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    01 USV Private Limited (1)

    02 Auro Peptides Limited (1)

    03 MSN Laboratories (1)

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    01 ETELCALCETIDE HYDROCHLORIDE (3)

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    USV PRIVATE LTD

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    • FDA
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    • WHO-GMP
    Virtual BoothUSV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
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    ETELCALCETIDE HYDROCHLORIDE

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    35768
    Active
    2021-07-22
    Complete
    2021-09-07
    2021-03-24
    II
    USV Private Limited

    CPhI Worldwide, Milan

    Booth #10F41

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    AURO PEPTIDES LTD

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      ETELCALCETIDE HYDROCHLORIDE

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      URL Supplier Web Content
      35386
      Active
      2020-11-12
      Complete
      2021-01-11
      2020-11-12
      II
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      MSN LIFE SCIENCES PRIVATE LTD

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      ETELCALCETIDE HYDROCHLORIDE

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      URL Supplier Web Content
      35097
      Active
      2020-09-01
      Complete
      2020-10-23
      2020-09-01
      II
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      Looking for 1262780-97-1 / Etelcalcetide API manufacturers, exporters & distributors?

      Etelcalcetide manufacturers, exporters & distributors 1

      21

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

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

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

      API | Excipient name

      Etelcalcetide

      Synonyms

      Velcalcetide, Parsabiv, 1262780-97-1, Kai-4169, Amg-416, Telcalcetide

      Cas Number

      1262780-97-1

      Unique Ingredient Identifier (UNII)

      60ME133FJB

      About Etelcalcetide

      Etelcalcetide is a calcimimetic and calcium-sensing receptor (CaSR) agonist composed of a synthetic peptide comprised of seven D-amino acids that can be used to treat secondary hyperparathyroidism (sHPT) in hemodialysis patients with chronic kidney disease (CKD). Upon intravenous administration, etelcalcetide mimics calcium and allosterically binds to and activates the CaSR expressed by the parathyroid gland. This suppresses the synthesis and secretion of parathyroid hormone (PTH), thereby reducing PTH levels and lowering serum calcium and phosphorus levels. Elevated PTH is often observed in patients with CKD and is associated with dysregulated calcium-phosphate homeostasis.

      Etelcalcetide Manufacturers

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

      Etelcalcetide Suppliers

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

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

      Etelcalcetide USDMF

      A Etelcalcetide DMF (Drug Master File) is a document detailing the whole manufacturing process of Etelcalcetide active pharmaceutical ingredient (API) in detail. Different forms of Etelcalcetide DMFs exist exist since differing nations have different regulations, such as Etelcalcetide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

      A Etelcalcetide DMF submitted to regulatory agencies in the US is known as a USDMF. Etelcalcetide USDMF includes data on Etelcalcetide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Etelcalcetide USDMF is kept confidential to protect the manufacturer’s intellectual property.

      click here to find a list of Etelcalcetide suppliers with USDMF on PharmaCompass.

      Etelcalcetide Manufacturers | Traders | Suppliers

      Etelcalcetide Manufacturers, Traders, Suppliers 1
      94

      We have 3 companies offering Etelcalcetide

      Get in contact with the supplier of your choice:

      1. USV Private Limited
      2. Auro Peptides Limited
      3. MSN Laboratories
      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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