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

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    Cilastatin

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    PRICE INFORMATION

    INTERMEDIATES

    DOSSIERs // Finished Dosage Forms

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    PharmaCompass

    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    01 Choongwae Pharma Corporation (1)

    02 RANBAXY LABORATORIES LIMITED (1)

    03 Savior Lifetec Corporation (1)

    04 Unimark Remedies Limited (1)

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    01 CILASTATIN ACID (2)

    02 CILASTATIN ACID (INTERMEDIATE) (1)

    03 CILASTATIN SODIUM STERILE (1)

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    01 India (2)

    02 Taiwan (1)

    03 Blank (1)

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    01 Active (3)

    02 Inactive (1)

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    01 Complete (1)

    02 Blank (3)

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    JW PHARMACEUTICAL CORP

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      CILASTATIN ACID

      PDF Supplier PDF
      URL Supplier Web Content
      23181
      Active
      2009-10-15
      N/A
      II
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      SUN PHARMACEUTICAL INDUSTRIES LTD

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      • WHO-GMP
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      CILASTATIN ACID

      PDF Supplier PDF
      URL Supplier Web Content
      20046
      Inactive
      2006-12-16
      N/A
      II
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      SAVIOR LIFETEC CORP

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      CILASTATIN SODIUM STERILE

      PDF Supplier PDF
      URL Supplier Web Content
      19938
      Active
      2006-10-30
      Complete
      2013-06-06
      2013-05-22
      II
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      UNIMARK REMEDIES LTD

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      CILASTATIN ACID (INTERMEDIATE)

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      28321
      Active
      2014-06-03
      N/A
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      Looking for 82009-34-5 / Cilastatin API manufacturers, exporters & distributors?

      Cilastatin manufacturers, exporters & distributors 1

      11

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

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

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

      API | Excipient name

      Cilastatin

      Synonyms

      82009-34-5, Cilastatina, Cilastatine, Cilastatinum, Mk-791, Cilastatin (inn)

      Cas Number

      82009-34-5

      Unique Ingredient Identifier (UNII)

      141A6AMN38

      About Cilastatin

      A renal dehydropeptidase-I and leukotriene D4 dipeptidase inhibitor. Since the antibiotic, IMIPENEM, is hydrolyzed by dehydropeptidase-I, which resides in the brush border of the renal tubule, cilastatin is administered with imipenem to increase its effectiveness. The drug also inhibits the metabolism of leukotriene D4 to leukotriene E4.

      Cilastatin Manufacturers

      A Cilastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cilastatin, including repackagers and relabelers. The FDA regulates Cilastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cilastatin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

      Cilastatin Suppliers

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

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

      Cilastatin USDMF

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

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

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

      Cilastatin Manufacturers | Traders | Suppliers

      Cilastatin Manufacturers, Traders, Suppliers 1
      13

      We have 4 companies offering Cilastatin

      Get in contact with the supplier of your choice:

      1. Choongwae Pharma Corporation
      2. RANBAXY LABORATORIES LIMITED
      3. Savior Lifetec Corporation
      4. Unimark Remedies Limited
      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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