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    Pralatrexate

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    TAPI Technology & API Services

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-03-10

    Pay. Date : 2013-07-16

    DMF Number : 27298

    Submission : 2013-08-23

    Status : Active

    Type : II

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    Hetero Drugs

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    DMF Review : Reviewed

    Rev. Date : 2013-11-14

    Pay. Date : 2013-07-05

    DMF Number : 27232

    Submission : 2013-06-19

    Status : Active

    Type : II

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    Date of Issue : 2025-09-03

    Valid Till : 2028-08-08

    Written Confirmation Number : WC-0041

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    NDC Package Code : 68554-0071

    Start Marketing Date : 2009-09-24

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2025-11-12

    Pay. Date : 2025-09-26

    DMF Number : 42631

    Submission : 2025-09-29

    Status : Active

    Type : II

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    Sicor

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    NDC Package Code : 53183-4020

    Start Marketing Date : 2013-07-17

    End Marketing Date : 2026-12-31

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    Apicore

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    NDC Package Code : 65392-2510

    Start Marketing Date : 2009-09-24

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (0.5kg/.5kg)

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    Teva Pharmaceutical Industries

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    NDC Package Code : 47848-045

    Start Marketing Date : 2013-03-18

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (100kg/100kg)

    Marketing Category : BULK INGREDIENT

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    Looking for 146464-95-1 / Pralatrexate API manufacturers, exporters & distributors?

    Pralatrexate manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Pralatrexate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pralatrexate manufacturer or Pralatrexate supplier for your needs.

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

    API | Excipient name

    Pralatrexate

    Synonyms

    146464-95-1, Folotyn, 10-propargyl-10-deazaaminopterin, Hsdb 7786, Pdx, Pralatrexate(folotyn)

    Cas Number

    146464-95-1

    Unique Ingredient Identifier (UNII)

    A8Q8I19Q20

    About Pralatrexate

    Pralatrexate is a folate analogue inhibitor of dihydrofolate reductase (DHFR) exhibiting high affinity for reduced folate carrier-1 (RFC-1) with antineoplastic and immunosuppressive activities. Pralatrexate selectively enters cells expressing RFC-1; intracellularly, this agent is highly polyglutamylated and competes for the folate binding site of DHFR, blocking tetrahydrofolate synthesis, which may result in depletion of nucleotide precursors; inhibition of DNA, RNA and protein synthesis; and apoptotic tumor cell death. Efficient intracellular polyglutamylation of pralatrexate results in higher intracellular concentrations compared to non-polyglutamylated pralatrexate, which is more readily effuxed by the MRP (multidrug resistance protein) drug efflux pump. RFC-1, an oncofetal protein expressed at highest levels during embryonic development, may be over-expressed on the cell surfaces of various cancer cell types.

    Pralatrexate Manufacturers

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

    Pralatrexate Suppliers

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

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

    Pralatrexate Manufacturers | Traders | Suppliers

    Pralatrexate Manufacturers, Traders, Suppliers 1
    74

    We have 8 companies offering Pralatrexate

    Get in contact with the supplier of your choice:

    1. TAPI Technology & API Services
    2. Anax Laboratories
    3. Apicore
    4. Epoch Labs
    5. GLAND PHARMA LIMITED
    6. Hetero Drugs
    7. Sicor
    8. Teva Pharmaceutical Industries
    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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