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    Also known as: 3223-07-2, Melphalan hcl, Alkeran hydrochloride, Cb 3025 hydrochloride, Phenylalanine mustard hydrochloride, L-sarcolysine hydrochloride
    Molecular Formula
    C13H19Cl3N2O2
    Molecular Weight
    341.7  g/mol
    InChI Key
    OUUYBRCCFUEMLH-YDALLXLXSA-N
    FDA UNII
    1VXP4V453T
    Melphalan Hydrochloride
    Melphalan Hydrochloride is a bifunctional alkylating agent and phenylalanine derivative of nitrogen mustard. Melphalan hydrochloride is converted into highly reactive ethylenimmonium intermediates that induce covalent guanine N7-N7 intra- and inter-crosslinks and alkylation of adenine N3 of DNA. This agent also alkylates RNA and protein structures. As a result RNA transcription and protein synthesis are inhibited, ultimately leading to cell growth arrest and/or death.
    1 2D Structure

    Melphalan Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-2-amino-3-[4-[bis(2-chloroethyl)amino]phenyl]propanoic acid;hydrochloride
    2.1.2 InChI
    InChI=1S/C13H18Cl2N2O2.ClH/c14-5-7-17(8-6-15)11-3-1-10(2-4-11)9-12(16)13(18)19;/h1-4,12H,5-9,16H2,(H,18,19);1H/t12-;/m0./s1
    2.1.3 InChI Key
    OUUYBRCCFUEMLH-YDALLXLXSA-N
    2.1.4 Canonical SMILES
    C1=CC(=CC=C1CC(C(=O)O)N)N(CCCl)CCCl.Cl
    2.1.5 Isomeric SMILES
    C1=CC(=CC=C1C[C@@H](C(=O)O)N)N(CCCl)CCCl.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    1VXP4V453T
    2.3 Synonyms
    2.3.1 Depositor-Supplied Synonyms

    1. 3223-07-2

    2. Melphalan Hcl

    3. Alkeran Hydrochloride

    4. Cb 3025 Hydrochloride

    5. Phenylalanine Mustard Hydrochloride

    6. L-sarcolysine Hydrochloride

    7. Sarcolysin Hydrochloride, L-

    8. Alanine, 3-(p-(bis(2-chloroethyl)amino)phenyl)-, Monohydrochloride, L-

    9. 1vxp4v453t

    10. Cb-3025 Hydrochloride

    11. Evomela

    12. (2s)-2-amino-3-[4-[bis(2-chloroethyl)amino]phenyl]propanoic Acid;hydrochloride

    13. L-phenylalanine Mustard Hydrochloride

    14. 4-bis(2-chlorethyl)-amino-l-phenylalanine Hydrochloride

    15. Alanine Nitrogen Mustard

    16. Alkeran (tn)

    17. L-phenylalanine, 4-(bis(2-chloroethyl)amino)-, Monohydrochloride

    18. (s)-2-amino-3-(4-(bis(2-chloroethyl)amino)phenyl)propanoic Acid Hydrochloride

    19. Nsc8806

    20. Wln: Qvyz1r Dn2g2g &gh

    21. Evomela (tn)

    22. Melfalan Hydrochloride

    23. Alkeran (glaxosmith)

    24. L-alanine, Hydrochloride

    25. Unii-1vxp4v453t

    26. Schembl41335

    27. Chembl1200863

    28. Dtxsid60872785

    29. L-phenylalanine, Monohydrochloride

    30. Mfcd01674304

    31. Alanine Nitrogen Mustard Hydrochloride

    32. Akos025401785

    33. Melphalan Hydrochloride [vandf]

    34. Melphalan Hydrochloride [usp-rs]

    35. Melphalan Hydrochloride [who-dd]

    36. Ac-25549

    37. Ai3-26377

    38. Melphalan Hydrochloride [orange Book]

    39. D08173

    40. 223m072

    41. Q27252967

    42. 4-[bis(2-chloroethyl)-amino]-phenylalanine Hydrochloride

    43. 4-[bis(2-chloroethyl)-amino]-l-phenylalanine Hydrochloride

    44. L-3-(p-(bis(2-chloroethyl)amino)phenyl)alanine Monohydrochloride

    45. L-alanine, 3-(p-(bis(2-chloroethyl)amino)phenyl)-, Hydrochloride

    46. L-phenylalanine, 4-(bis(2-chloroethyl)amino)-, Hydrochloride (1:1)

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 341.7 g/mol
    Molecular Formula C13H19Cl3N2O2
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count8
    Exact Mass340.051211 g/mol
    Monoisotopic Mass340.051211 g/mol
    Topological Polar Surface Area66.6 Ų
    Heavy Atom Count20
    Formal Charge0
    Complexity265
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Indication

    High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:

    - multiple myeloma,

    - malignant lymphoma (Hodgkin, non-Hodgkin lymphoma),

    - acute lymphoblastic and myeloblastic leukemia,

    - childhood neuroblastoma,

    - ovarian cancer ,

    - mammary adenocarcinoma.

    Phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in malignant haematological diseases in adults.

    Phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:

    - Myeloablative conditioning (MAC) treatment in case of malignant haematological diseases

    - RIC treatment in case of non-malignant haematological diseases.

    5 Pharmacology and Biochemistry
    5.1 ATC Code

    L01AA03

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    Submission : 2015-07-09

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    Type : II

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    Nerpharma Srl

    Italy

    USDMF

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    Nerpharma Srl

    Italy
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    Antibody Engineering
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-12-18

    Pay. Date : 2014-07-23

    DMF Number : 27306

    Submission : 2013-07-10

    Status : Active

    Type : II

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    Olon Spa

    Italy

    USDMF

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    Not Confirmed

    09

    Olon Spa

    Italy
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    Antibody Engineering
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-06-01

    Pay. Date : 2015-05-22

    DMF Number : 20883

    Submission : 2007-09-24

    Status : Active

    Type : II

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    Antibody Engineering
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    Shilpa Pharma Lifesciences Ltd

    India
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    Antibody Engineering
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-04-23

    Pay. Date : 2014-12-31

    DMF Number : 28930

    Submission : 2015-01-03

    Status : Active

    Type : II

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    01

    Apothecon Pharmaceuticals

    India
    Antibody Engineering
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    Apothecon Pharmaceuticals

    India
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    Antibody Engineering
    Not Confirmed
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    Melphalan Hydrochloride IH

    Date of Issue : 2022-09-30

    Valid Till : 2025-09-08

    Written Confirmation Number : WC-0369n

    Address of the Firm : Plot No 1134, 1135, 1136,1137,11438, RN 1144 A & 8,1138 A & 8, Padra Jambusar Hi...

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    02

    Emcure Pharmaceuticals

    India
    Antibody Engineering
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    Emcure Pharmaceuticals

    India
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    Antibody Engineering
    Not Confirmed
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    Melphalan Hydrochloride USP

    Date of Issue : 2019-10-07

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0226

    Address of the Firm : D-24 and D24/1 MIDC Kurkumbh Tal. Daund, Dist Pune 413 802, Maharashtra State

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    03

    Hetero Drugs

    India
    Antibody Engineering
    Not Confirmed
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    Hetero Drugs

    India
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    Antibody Engineering
    Not Confirmed
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    Melphalan Hydrochloride IH

    Date of Issue : 2022-09-16

    Valid Till : 2025-08-08

    Written Confirmation Number : WC-0041

    Address of the Firm : Unit-I, Survey No.10, I.D.A, Gaddapotharam Village, Jinnaram Mandal,Medak Dist, ...

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    04

    Shilpa Medicare

    India
    Antibody Engineering
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    Shilpa Medicare

    India
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    Antibody Engineering
    Not Confirmed
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    Melphalan HCl IH

    Date of Issue : 2021-06-11

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0147A3

    Address of the Firm : 100% EOU, Raichur Industrial Growth Centre, Plot No. 33, 33A, 40-47, Chicksugur-...

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    05

    Sionc Pharmaceuticals

    India
    Antibody Engineering
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    Sionc Pharmaceuticals

    India
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    Melphalan Hydrochloride IH

    Date of Issue : 2020-07-23

    Valid Till : 2023-05-11

    Written Confirmation Number : WC-0273

    Address of the Firm : Plot No. 34A, J.N.Pharma City, Thanam (V), Parawada (M), Vishakhapatnam-District...

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    NDC API

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    01

    Farmabios S.p.A.

    Germany
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    AES 2024
    Not Confirmed
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    Virtual BoothAxplora- The partner of choice for complex APIs.

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    MELPHALAN HYDROCHLORIDE

    NDC Package Code : 46439-8735

    Start Marketing Date : 2011-05-01

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    Axplora CB

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    Granules India Limited

    India
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    AES 2024
    Not Confirmed
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    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    MELPHALAN HYDROCHLORIDE

    NDC Package Code : 62207-978

    Start Marketing Date : 2021-08-09

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    Granules India

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    03

    Apothecon Pharmaceuticals Pvt Ltd

    India
    AES 2024
    Not Confirmed
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    Apothecon Pharmaceuticals Pvt Ltd

    India
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    AES 2024
    Not Confirmed
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    MELPHALAN HYDROCHLORIDE

    NDC Package Code : 76339-501

    Start Marketing Date : 2024-01-31

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (4.999kg/4.999kg)

    Marketing Category : BULK INGREDIENT

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    04

    Aurobindo Pharma Limited

    India
    AES 2024
    Not Confirmed
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    Aurobindo Pharma Limited

    India
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    AES 2024
    Not Confirmed
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    MELPHALAN HYDROCHLORIDE

    NDC Package Code : 59651-684

    Start Marketing Date : 2023-12-06

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

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    05

    Chemcon, GmbH

    Germany
    AES 2024
    Not Confirmed
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    Chemcon, GmbH

    Germany
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    AES 2024
    Not Confirmed
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    MELPHALAN HYDROCHLORIDE

    NDC Package Code : 64757-0013

    Start Marketing Date : 2011-06-16

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    Zhejiang ChemPacific Corporation

    U.S.A
    AES 2024
    Not Confirmed
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    Zhejiang ChemPacific Corporation

    U.S.A
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    AES 2024
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    MELPHALAN HYDROCHLORIDE

    NDC Package Code : 59981-016

    Start Marketing Date : 2010-10-12

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    07

    Emcure Pharmaceuticals Limited

    India
    AES 2024
    Not Confirmed
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    Emcure Pharmaceuticals Limited

    India
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    AES 2024
    Not Confirmed
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    MELPHALAN HYDROCHLORIDE

    NDC Package Code : 14593-847

    Start Marketing Date : 2023-12-22

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    08

    Hetero Labs Limited

    India
    AES 2024
    Not Confirmed
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    Hetero Labs Limited

    India
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    AES 2024
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    MELPHALAN HYDROCHLORIDE

    NDC Package Code : 68554-0087

    Start Marketing Date : 1992-11-18

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    Patheon Manufacturing Services LLC

    U.S.A
    AES 2024
    Not Confirmed
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    Patheon Manufacturing Services LLC

    U.S.A
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    AES 2024
    Not Confirmed
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    MELPHALAN HYDROCHLORIDE

    NDC Package Code : 63552-076

    Start Marketing Date : 2016-03-31

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (50mg/10mL)

    Marketing Category : DRUG FOR FURTHER PROCESSING

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    10

    SHILPA PHARMA LIFESCIENCES LIMITED

    India
    AES 2024
    Not Confirmed
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    SHILPA PHARMA LIFESCIENCES LIMITED

    India
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    AES 2024
    Not Confirmed
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    MELPHALAN HYDROCHLORIDE

    NDC Package Code : 82920-020

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

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    Listed Suppliers

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    Axplora

    Germany
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    AES 2024
    Not Confirmed
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    Virtual BoothAxplora- The partner of choice for complex APIs.

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    Melphalan Hydrochloride

    About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...

    Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.
    Axplora CB

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    ChemWerth Inc

    U.S.A
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    Booth #12.1F43
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    Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Melphalan Hydrochloride

    About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...

    Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs to regulated markets worldwide and has exclusive partnerships for new product development, compliance support and secure supply chain logistics. ChemWerth has access to over 500 APIs and more than 30 manufacturing facilities in the US, Europe, India and China. ChemWerth acts as a regulatory agent for over 25 FDA-approved facilities and sells more than 100 products. It has established its presence in 38 countries. In 2020, ChemWerth filed its 500th DMF with the FDA.
    Chemwerth Compnay Banner

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    03

    Aspire Lifesciences Pvt Ltd

    India
    AES 2024
    Not Confirmed
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    Aspire Lifesciences Pvt Ltd

    India
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    MELPHALAN HYDROCHLORIDE

    About the Company : Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent ...

    Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent growth, unique technologies and world class quality healthcare products. Aspire is pioneer in manufacturing and sourcing unique healthcare products. True to the statement, “Where the future started yesterday” with a foresight on the current trends in the healthcare market, Aspire has grown from strength combining its research strength, Human resources and well established quality systems. Aspire has crossed numerous milestones in a comparatively short period since its inception.
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    04

    Aurobindo Pharma Limited

    India
    AES 2024
    Not Confirmed
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    Aurobindo Pharma Limited

    India
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    Melphalan Hydrochloride

    About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company comme...

    Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others.
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    Emcure Pharmaceuticals

    India
    AES 2024
    Not Confirmed
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    Emcure Pharmaceuticals

    India
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    AES 2024
    Not Confirmed
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    Melphalan Hydrochloride

    About the Company : Emcure Pharmaceuticals Ltd. is a fast-growing fully integrated Indian pharmaceutical company with a global presence engaged in developing, manufacturing, and marketing a broad rang...

    Emcure Pharmaceuticals Ltd. is a fast-growing fully integrated Indian pharmaceutical company with a global presence engaged in developing, manufacturing, and marketing a broad range of pharmaceutical products. Its core strength lies in developing and manufacturing differentiated pharmaceutical products in-house, which it commercializes across geographies. Emcure has launched 6 biosimilars in the Domestic Market & RoW markets & Its subsidiary - Gennova is leading the creation of India’s first indigenous mRNA vaccine to combat COVID- 19 which is currently under trial.
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    06

    Hetero Drugs

    India
    AES 2024
    Not Confirmed
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    Hetero Drugs

    India
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    AES 2024
    Not Confirmed
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    Melphalan Hydrochloride

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    07

    Hubei Honch Pharmaceutical

    China
    AES 2024
    Not Confirmed
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    Hubei Honch Pharmaceutical

    China
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    AES 2024
    Not Confirmed
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    Melphalan Hydrochloride

    About the Company : Hubei Hongzhong Pharmaceutical Co., Ltd. was founded in 2007 and is located in Li Shizhen Pharmaceutical Industrial Park, Qichun County, Hubei Province. The company's products have...

    Hubei Hongzhong Pharmaceutical Co., Ltd. was founded in 2007 and is located in Li Shizhen Pharmaceutical Industrial Park, Qichun County, Hubei Province. The company's products have been focusing on the research and development and production of the latest anti-tumor and high-end animal raw materials. In 2011, it was certified as a high-tech enterprise for the first time, has more than 20 domestic and foreign invention patents. The company is a postgraduate workstation issued by the Hubei Provincial Department of Education, and has won the Hubei Provincial Science and Technology Innovation Award and Science and Technology Progress Award.
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    08

    Olon S.p.A

    Italy
    AES 2024
    Not Confirmed
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    Olon S.p.A

    Italy
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    Melphalan Hydrochloride

    About the Company : We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities. Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (...

    We produce Active Pharmaceutical Ingredients (APIs) providing integrated full-service capabilities. Olon’s ability to develop and manufacture Active Pharmaceutical Ingredients (APIs) in our network of facilities allows clients full access to integrated services resulting in faster production and delivery timelines, with one of the most extensive track records. We rely on synthetic and biological processes both for generic and contract development and the manufacturing market, in a full cGMPs environment, following ICH Q7 compliance.
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    09

    Sichuan Huiyu Pharmaceutical

    China
    AES 2024
    Not Confirmed
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    Sichuan Huiyu Pharmaceutical

    China
    arrow
    AES 2024
    Not Confirmed
    • fda
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    Melphalan Hydrochloride

    About the Company : Huiyu Pharma, established in Oct. 2010, is a specialized pharmaceutical company focusing on developing and manufacturing high-quality oncology products. At present, products in our...

    Huiyu Pharma, established in Oct. 2010, is a specialized pharmaceutical company focusing on developing and manufacturing high-quality oncology products. At present, products in our list include the following:Azacitidine, Bendamustine HCl, Bortezomib, Camptothecin, Carboplatin, Decitabine, Docetaxel, Doxorubicin HCl, Epirubicin HCl, Gemcitabine Hydrochloride, Irinotecan Hydrochloride, Methotrexate, Oxaliplatin, Paclitaxel, Pemetrexed disodium...We welcome those traders, distributors, and wholesalers who are interested in our products.
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    10

    Sionc Pharmaceuticals

    India
    AES 2024
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    Sionc Pharmaceuticals

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    Melphalan Hydrochloride

    About the Company : Sionc pharmaceuticals is specialized in manufacturing of complex and niche Active Pharmaceutical Ingredients in various therapeutic categories. Sionc has evolved as a reliable cont...

    Sionc pharmaceuticals is specialized in manufacturing of complex and niche Active Pharmaceutical Ingredients in various therapeutic categories. Sionc has evolved as a reliable contributor in the generic drug industry for Regulatory markets with customer-centric approach since its inception in 2010. To Emerge as a Leading Global Pharmaceutical Company which creates value for all customers by offering excellence in product Quality Standard with committed service and be a significant contributor for global markets.
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    API Reference Price

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    [{"dataSource":"API Import","activeIngredients":"MELPHALAN HYDROCHLORIDE","year":"2021","qtr":"Q2","strtotime":1618425000,"product":"MELPHALAN HYDROCHLORIDE","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.68","actualQuantity":"680","unit":"GMS","unitRateFc":"250","totalValueFC":"169317.1","currency":"USD","unitRateINR":"18537.5","date":"15-Apr-2021","totalValueINR":"12605500","totalValueInUsd":"169317.1","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29224990","bill_no":"1000690","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"MELPHALAN HYDROCHLORIDE","year":"2021","qtr":"Q2","strtotime":1620757800,"product":"MELPHALAN HYDROCHLORIDE","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.83","actualQuantity":"831","unit":"GMS","unitRateFc":"250","totalValueFC":"212006.2","currency":"USD","unitRateINR":"18687.5","date":"12-May-2021","totalValueINR":"15529313","totalValueInUsd":"212006.2","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29224990","bill_no":"1000875","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"STRADA RIVOLTANA KM 6\/7 RODANO MI ITALY","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1628447400,"product":"MELPHALAN HYDROCHLORIDE","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"AXPLORA","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"1","unit":"GMS","unitRateFc":"178325","totalValueFC":"180567.1","currency":"USD","unitRateINR":"13392208","date":"09-Aug-2021","totalValueINR":"13392208","totalValueInUsd":"180567.1","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29224990","bill_no":"1001369","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"VIA PAVIA - 1 27027,GROPE ; P CAIROLI (PV 0","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674498600,"product":"MELPHALAN HYDROCHLORIDE (BATCH NO.22003MR45A)","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.35","actualQuantity":"350","unit":"GMS","unitRateFc":"250","totalValueFC":"88078.5","currency":"USD","unitRateINR":"20575","date":"24-Jan-2023","totalValueINR":"7201250","totalValueInUsd":"88078.5","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29224990","bill_no":"1000121","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"DIREZIONE E UFFICI STRADA RIVOLTANA KM 6-7 20090 RODANO (MI) ITALY ITALY","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701801000,"product":"MELPHALAN HYDROCHLORIDE (QTY:4 X 0.2 G, VALUE: USD 73.58\/EACH) (FOC)","address":"P.NO. 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D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718735400,"product":"MELPHALAN HYDROCHLORIDE","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"XXRMAXXOS XXP.AXX SOXXETAXXON XXCIOXXNICX","supplierCountry":"ITALY","foreign_port":"N\/A","customer":"NIL-MASKED","customerCountry":"INDIA","quantity":"1.65","actualQuantity":"1651","unit":"GMS","unitRateFc":"140","totalValueFC":"233412","currency":"USD","unitRateINR":"11802","date":"19-Jun-2024","totalValueINR":"19485102","totalValueInUsd":"233412","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29224990","bill_no":"1001129","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"}]
    15-Apr-2021
    19-Jun-2024
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    Drugs in Development

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    Avenacy Announces Launch of Melphalan Hydrochloride for Injection in the U.S. Market

    Details:

    Alkeran-Generic (melphalan hydrochloride) is a DNA alkylating agent of the bischloroethylamine type. It is approved for patients with multiple myeloma for whom oral therapy is not appropriate.


    Lead Product(s): Melphalan Hydrochloride

    Therapeutic Area: Oncology Brand Name: Alkeran-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 16, 2024

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    Avenacy

    U.S.A
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    Lead Product(s) : Melphalan Hydrochloride

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Avenacy Announces Launch of Melphalan Hydrochloride for Injection in the U.S. Market

    Details : Alkeran-Generic (melphalan hydrochloride) is a DNA alkylating agent of the bischloroethylamine type. It is approved for patients with multiple myeloma for whom oral therapy is not appropriate.

    Brand Name : Alkeran-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 16, 2024

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    Delcath Systems to Hold Investor Update on Focus Trial Data and Future Development Plans on December 2, 2021

    Details:

    The event will feature, updated Focus trial data and the role of Hepzato™ Kit (melphalan hydrochloride for injection/Hepatic Delivery System) as a potential treatment for patients with hepatic-dominant metastatic ocular melanoma.


    Lead Product(s): Melphalan Hydrochloride

    Therapeutic Area: Oncology Brand Name: Hepzato

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 05, 2021

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    Delcath Systems

    U.S.A
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    Lead Product(s) : Melphalan Hydrochloride

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Delcath Systems to Hold Investor Update on Focus Trial Data and Future Development Plans on Decemb...

    Details : The event will feature, updated Focus trial data and the role of Hepzato™ Kit (melphalan hydrochloride for injection/Hepatic Delivery System) as a potential treatment for patients with hepatic-dominant metastatic ocular melanoma.

    Brand Name : Hepzato

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 05, 2021

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    Delcath Completes Enrollment in its United States Registration Pivotal Trial (FOCUS) Investigating Melphalan/HDS in the Treatment of Patients with Unres...

    Details:

    Delcath have reached the minimum endpoint target enrollment in the FOCUS trial and expects to announce top-line results around the middle of this year.


    Lead Product(s): Melphalan Hydrochloride

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 13, 2020

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    Delcath Systems

    U.S.A
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    Lead Product(s) : Melphalan Hydrochloride

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Delcath Completes Enrollment in its United States Registration Pivotal Trial (FOCUS) Investigating...

    Details : Delcath have reached the minimum endpoint target enrollment in the FOCUS trial and expects to announce top-line results around the middle of this year.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 13, 2020

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    FDA Orange Book

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    DR REDDYS

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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    RLD : No

    TE Code : AP

    MELPHALAN HYDROCHLORIDE

    Brand Name : MELPHALAN HYDROCHLORIDE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG BASE/VIAL

    Approval Date : 2017-12-08

    Application Number : 203655

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

    Dr Reddy Company Banner

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    02

    ACROTECH BIOPHARMA

    U.S.A
    Medlab Asia & Asia Health
    Not Confirmed
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    ACROTECH BIOPHARMA

    U.S.A
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    Not Confirmed
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    RLD : Yes

    TE Code :

    MELPHALAN HYDROCHLORIDE

    Brand Name : EVOMELA

    Dosage Form : POWDER;INTRAVENOUS

    Dosage Strength : EQ 50MG BASE/VIAL

    Approval Date : 2016-03-10

    Application Number : 207155

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    03

    ACTAVIS LLC

    Ireland
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    RLD : No

    TE Code :

    MELPHALAN HYDROCHLORIDE

    Brand Name : MELPHALAN HYDROCHLORIDE

    Dosage Form : POWDER;INTRAVENOUS

    Dosage Strength : EQ 50MG BASE/VIAL

    Approval Date : 2020-03-06

    Application Number : 209323

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    APOTEX

    Canada
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    RLD : Yes

    TE Code :

    MELPHALAN HYDROCHLORIDE

    Brand Name : IVRA

    Dosage Form : SOLUTION;INTRAVENOUS

    Dosage Strength : EQ 90MG BASE/ML (EQ 90MG BASE/ML)

    Approval Date : 2023-08-18

    Application Number : 217110

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    BPI LABS

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    RLD : No

    TE Code : AP

    MELPHALAN HYDROCHLORIDE

    Brand Name : MELPHALAN HYDROCHLORIDE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG BASE/VIAL

    Approval Date : 2020-05-08

    Application Number : 209197

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    DELCATH SYSTEMS INC

    U.S.A
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    RLD : Yes

    TE Code :

    MELPHALAN HYDROCHLORIDE

    Brand Name : HEPZATO

    Dosage Form : POWDER;INTRA-ARTERIAL

    Dosage Strength : EQ 50MG BASE/VIAL

    Approval Date : 2023-08-14

    Application Number : 201848

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    FRESENIUS KABI USA

    U.S.A
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    FRESENIUS KABI USA

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    RLD : No

    TE Code : AP

    MELPHALAN HYDROCHLORIDE

    Brand Name : MELPHALAN HYDROCHLORIDE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG BASE/VIAL

    Approval Date : 2017-12-22

    Application Number : 203393

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    GLAND PHARMA LTD

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    RLD : No

    TE Code : AP

    MELPHALAN HYDROCHLORIDE

    Brand Name : MELPHALAN HYDROCHLORIDE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG BASE/VIAL

    Approval Date : 2019-05-28

    Application Number : 209826

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    SAGENT PHARMS INC

    U.S.A
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    SAGENT PHARMS INC

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    RLD : No

    TE Code : AP

    MELPHALAN HYDROCHLORIDE

    Brand Name : MELPHALAN HYDROCHLORIDE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG BASE/VIAL

    Approval Date : 2017-02-28

    Application Number : 201379

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    USWM

    U.S.A
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    USWM

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    RLD : No

    TE Code :

    MELPHALAN HYDROCHLORIDE

    Brand Name : MELPHALAN HYDROCHLORIDE

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : EQ 50MG BASE/VIAL

    Approval Date : 2019-05-03

    Application Number : 207032

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - INJECTABLE;INJECTION - EQ 50MG BASE/...DOSAGE - INJECTABLE;INJECTION - EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 20207

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    DOSAGE - POWDER;INTRAVENOUS - EQ 50MG BASE/VI...DOSAGE - POWDER;INTRAVENOUS - EQ 50MG BASE/VIAL

    USFDA APPLICATION NUMBER - 207155

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