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    Also known as: 1306760-87-1, Rpc1063, Rpc-1063, Ozanimod (rpc1063), (s)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1h-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile, Z80293urpv
    Molecular Formula
    C23H24N4O3
    Molecular Weight
    404.5  g/mol
    InChI Key
    XRVDGNKRPOAQTN-FQEVSTJZSA-N
    FDA UNII
    Z80293URPV
    Ozanimod Hydrochloride
    Ozanimod is an orally bioavailable sphingosine-1-phosphate (S1P) receptors 1 (S1PR1, S1P1) and 5 (S1PR5, S1P5) modulator, with potential anti-inflammatory and immunomodulating activities. Upon oral administration, ozanimod selectively targets and binds to S1PR1 on lymphocytes and induces S1PR1 internalization and degradation. This results in the sequestration of lymphocytes in lymph nodes. By preventing egress of lymphocytes, ozanimod reduces both the amount of circulating peripheral lymphocytes and the infiltration of lymphocytes into target tissues. This prevents a lymphocyte-mediated immune response and may reduce inflammation. S1PR1, a G-protein coupled receptor, plays a key role in lymphocyte migration from lymphoid tissues. Modulation of S1PR5 by ozanimod may be neuroprotective.
    1 2D Structure

    Ozanimod Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-[3-[(1S)-1-(2-hydroxyethylamino)-2,3-dihydro-1H-inden-4-yl]-1,2,4-oxadiazol-5-yl]-2-propan-2-yloxybenzonitrile
    2.1.2 InChI
    InChI=1S/C23H24N4O3/c1-14(2)29-21-9-6-15(12-16(21)13-24)23-26-22(27-30-23)19-5-3-4-18-17(19)7-8-20(18)25-10-11-28/h3-6,9,12,14,20,25,28H,7-8,10-11H2,1-2H3/t20-/m0/s1
    2.1.3 InChI Key
    XRVDGNKRPOAQTN-FQEVSTJZSA-N
    2.1.4 Canonical SMILES
    CC(C)OC1=C(C=C(C=C1)C2=NC(=NO2)C3=C4CCC(C4=CC=C3)NCCO)C#N
    2.1.5 Isomeric SMILES
    CC(C)OC1=C(C=C(C=C1)C2=NC(=NO2)C3=C4CC[C@@H](C4=CC=C3)NCCO)C#N
    2.2 Other Identifiers
    2.2.1 UNII
    Z80293URPV
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Rpc1063

    2.3.2 Depositor-Supplied Synonyms

    1. 1306760-87-1

    2. Rpc1063

    3. Rpc-1063

    4. Ozanimod (rpc1063)

    5. (s)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1h-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile

    6. Z80293urpv

    7. Zeposia

    8. Unii-z80293urpv

    9. Benzonitrile, 5-(3-((1s)-2,3-dihydro-1-((2-hydroxyethyl)amino)-1h-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-(1-methylethoxy)-

    10. Ozanimod [inn]

    11. 5-[3-[(1~{s})-1-(2-hydroxyethylamino)-2,3-dihydro-1~{h}-inden-4-yl]-1,2,4-oxadiazol-5-yl]-2-propan-2-yloxy-benzenecarbonitrile

    12. Benzonitrile, 5-[3-[(1s)-2,3-dihydro-1-[(2-hydroxyethyl)amino]-1h-inden-4-yl]-1,2,4-oxadiazol-5-yl]-2-(1-methylethoxy)-

    13. Ozanimod [usan:inn]

    14. 5-[3-[(1s)-1-(2-hydroxyethylamino)-2,3-dihydro-1h-inden-4-yl]-1,2,4-oxadiazol-5-yl]-2-propan-2-yloxybenzonitrile

    15. Rpc 1063

    16. Ozanimod [usan]

    17. Ozanimod; Rpc1063

    18. Ozanimod (usan/inn)

    19. Ozanimod [mi]

    20. Ozanimod [who-dd]

    21. Gtpl8709

    22. Schembl2195490

    23. Chembl3707247

    24. Amy3373

    25. Dtxsid501026488

    26. Bcp16513

    27. Ex-a1316

    28. Rpc1063:rpc-1063

    29. Bdbm50507186

    30. Mfcd28386168

    31. S7952

    32. Akos026674086

    33. Zinc116109867

    34. Ccg-268695

    35. Cs-5070

    36. Db12612

    37. Ac-29883

    38. As-75063

    39. Hy-12288

    40. J3.612.016i

    41. D10968

    42. P14657

    43. Q21098986

    44. 5-{3-[(1s)-1-[(2-hydroxyethyl)amino]-2,3-dihydro-1h-inden-4-yl]-1,2,4-oxadiazol-5-yl}-2-(propan-2-yloxy)benzonitrile

    45. Jeu

    2.4 Create Date
    2011-06-13
    3 Chemical and Physical Properties
    Molecular Weight 404.5 g/mol
    Molecular Formula C23H24N4O3
    XLogP33.1
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count7
    Exact Mass404.18484064 g/mol
    Monoisotopic Mass404.18484064 g/mol
    Topological Polar Surface Area104 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity609
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Ozanimod is indicated for adults in the treatment of relapsing forms of MS, which may include relapsing-remitting disease, clinically isolated syndrome, and active secondary progressive MS.

    FDA Label

    Multiple sclerosis

    - Zeposia is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.

    Ulcerative colitis

    - Zeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Ozanimod reduces circulating lymphocytes that cause the neuroinflammation associated with MS, reducing debilitating symptoms and, possibly, disease progression. During clinical trials, ozanimod reduced MS-associated brain volume loss in several regions. Ozanimod causes the sequestration of peripheral lymphocytes, reducing circulating lymphocytes in the gastrointestinal tract.

    5.2 MeSH Pharmacological Classification

    Sphingosine 1 Phosphate Receptor Modulators

    Agents that affect the function of G-protein coupled SPHINGOSINE 1-PHOSPHATE RECEPTORS. Their binding to the receptors blocks lymphocyte migration and are often used as IMMUNOSUPPRESSANTS. (See all compounds classified as Sphingosine 1 Phosphate Receptor Modulators.)

    5.3 ATC Code

    L04AA38

    L - Antineoplastic and immunomodulating agents

    L04 - Immunosuppressants

    L04A - Immunosuppressants

    L04AA - Selective immunosuppressants

    L04AA38 - Ozanimod

    5.4 Absorption, Distribution and Excretion

    Absorption

    Ozanimod is absorbed in the gastrointestinal tract after oral administration. The Cmax of ozanimod is 0.244 ng/mL and is achieved at 6 to 8 hours after administration, reaching steady-state at about 102 hours after administration. The AUC is 4.46 ng*h/mL. Its delayed absorption reduces effects that may occur after the first dose, such as heart rate changes. The peak plasma concentration of ozanimod is low due to a high volume of distribution.

    Route of Elimination

    The kidneys are not a major source of elimination for ozanimod. After a 0.92 mg dose of radiolabeled ozanimod was administered, about 26% of the labeled drug was accounted for in the urine and 37 % in the feces, mainly in the form of inactive metabolites.

    Volume of Distribution

    The average volume of distribution of ozanimod is 5590L. Another reference mentions a volume of distribution ranging from 73-101 L/kg. This drug crosses the blood-brain barrier.

    Clearance

    The mean apparent oral clearance of ozanimod, according to prescribing information, is 192 L/h. Another reference indicates an oral clearance of 233 L/h.

    5.5 Metabolism/Metabolites

    Ozanimod has two major active metabolites CC112273 and CC1084037 and minor active metabolites such as RP101988, RP101075, and RP101509, which target the S1P1 and S1P5 receptors. The enzymes involved in the metabolism of ozanimod include ALDH/ADH, NAT-2, Monoamine Oxidase B, and AKR 1C1/1C2. After metabolism, ozanimod (6%), CC112273 (73%), and CC1084037 (15%) are accounted for in the circulation.

    5.6 Biological Half-Life

    The half-life of ozanimod ranges from 17-21 hours.

    5.7 Mechanism of Action

    Sphingosine1phosphate (S1P) is an important phospholipid that binds to various Gproteincoupled receptor subtypes, which can be identified as S1P15R. S1P and the receptors it binds to perform regular functions in the immune, cardiovascular, pulmonary, and nervous system. S1P can be expressed ubiquitously, playing an important role in regulating inflammation. S1P1R, S1P2R, and S1P3R receptors can be found in the cardiovascular, immune, and central nervous systems. S1P4R is found on lymphocytic and hematopoietic cells, while S1P5R expression is found only on the spleen (on natural killer cells) or in the central nervous system. Ozanimod is a selective modulator of S1P receptors and binds to S1P1R and S1P5R subtypes. The mechanism of action of ozanimod is not fully understood, but this drug likely reduces the migration of lymphocytes that usually aggravate the inflammation associated with MS.

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    Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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    Ozanimod Hydrochloride

    About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

    Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.
    Faran Shimi Pharmaceutical

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    06

    CHEMO

    Spain
    AusBiotech 2024
    Not Confirmed
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    CHEMO

    Spain
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    Ozanimod

    About the Company : More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, ...

    More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, and starts business activities trading with pharmaceutical raw materials. In the 80's, the company expanded its operations into the Industrial Business, developing and manufacturing active pharmaceutical ingredients (APIs) in Italy (Industriale Chimica) and in Spain (Quimica Sintetica). In the 90's, CHEMO starts developing and manufacturing high quality and technology finished dosage forms (FDFs).
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    07

    Maithri Drugs

    India
    AusBiotech 2024
    Not Confirmed
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    Maithri Drugs

    India
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    Ozanimod

    About the Company : Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its ex...

    Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its excellent research & development and aggressive growth strategies. Our 32 US DMFs and 9 CEPs in a short span attest to our R&D excellence. Maithri's manufacturing facility is located in Hyderabad. This facility is audited and approved by the US FDA. In addition, our facility is certified according to the standards of DCGI, WHO GMP, and ISO 9001:2015 We have a portfolio of 65 products and are continually expanding.
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    08

    Mankind Pharma

    India
    AusBiotech 2024
    Not Confirmed
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    Mankind Pharma

    India
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    Not Confirmed
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    Ozanimod

    About the Company : Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical com...

    Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical company in 1995. Today, we have 11,000 employees and are heading towards a turnover of INR 50000 million. Our vast network includes 50 C&F agents and 7500+ stockists. We provide a wide range of products – Antibiotic, Antifungal, NSAIDs, Gastrointestinal, Anthelmintic, Cardiovascular, Dermal, Erectile Dysfunction, and several other categories – across the nation.
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    09

    Saurav Chemicals

    India
    AusBiotech 2024
    Not Confirmed
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    Saurav Chemicals

    India
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    Not Confirmed
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    Ozanimod

    About the Company : Established in the early 90’s SCL offers a wide range of Active Pharmaceutical Ingredients and Intermediates to its customers worldwide. SCL’s products are exported to Europe, ...

    Established in the early 90’s SCL offers a wide range of Active Pharmaceutical Ingredients and Intermediates to its customers worldwide. SCL’s products are exported to Europe, Japan, Russia, South and Central America, ASEAN, W. Asia, MENA regions. SCL’s manufacturing facilities have been built to comply with EU GMP and U.S. FDA norms, and the API facility has been successfully certified as EU GMP compliant five times by the European Authorities. Latest certification was carried out by German Health Authority.
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    10

    Suzhou Biosyntech

    China
    AusBiotech 2024
    Not Confirmed
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    Suzhou Biosyntech

    China
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    Ozanimod

    About the Company : Suzhou Biosyntech is an R&D driven supplier for the Pharma market, the major business is on API and intermediates. Biosyntech has the ability to provide service from R&D developmen...

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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717525800,"product":"OZANIMOD HYDROCHLORIDE","address":"5\/502, GARDEN ESTATE,","city":"THANE, MAHARASHTRA.","supplier":"AMTEC HEALTHCARE PVT LTD","supplierCountry":"INDIA","foreign_port":"KUALA LUMPUR - INT\\'L","customer":"SUNSHINE WORLDWIDE BUSINESS LIMITED","customerCountry":"MALAYSIA","quantity":"0.37","actualQuantity":"370","unit":"GMS","unitRateFc":"21689.5","totalValueFC":"95246.2","currency":"INR","unitRateINR":21489.450000000001,"date":"05-Jun-2024","totalValueINR":"7951096.5","totalValueInUsd":"95246.2","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"1446834","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"MALAYSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"5\/502, GARDEN ESTATE,, THANE, MAHARASHTRA.","customerAddress":""}]
    05-Jun-2024
    05-Jun-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    FDF Dossiers

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    01

    NanoAlvand

    Iran
    arrow
    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

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    Regulatory Info :

    Registration Country : Iran

    Ozanimod

    Brand Name : Wellosia

    Dosage Form : Capsule

    Dosage Strength : 0.23MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Iran

    NanoAlvand

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    02

    NanoAlvand

    Iran
    arrow
    SupplySide West 2024
    Not Confirmed
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    Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

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    Regulatory Info :

    Registration Country : Iran

    Ozanimod

    Brand Name : Wellosia

    Dosage Form : Capsule

    Dosage Strength : 0.46MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Iran

    NanoAlvand

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    03

    NanoAlvand

    Iran
    arrow
    SupplySide West 2024
    Not Confirmed
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    • WHO-GMP

    Virtual BoothNanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.

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    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Iran

    Ozanimod

    Brand Name : Wellosia

    Dosage Form : Capsule

    Dosage Strength : 0.92MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Iran

    NanoAlvand

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    04

    Bristol Laboratories Ltd

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    Bristol Laboratories Ltd

    United Kingdom
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    SupplySide West 2024
    Not Confirmed
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    Virtual Booth Virtual Booth
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    Regulatory Info : RX

    Registration Country : USA

    OZANIMOD HYDROCHLORIDE

    Brand Name : ZEPOSIA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : EQ 0.23MG BASE

    Packaging :

    Approval Date : 2020-03-25

    Application Number : 209899

    Regulatory Info : RX

    Registration Country : USA

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    05

    Bristol Laboratories Ltd

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    Bristol Laboratories Ltd

    United Kingdom
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    SupplySide West 2024
    Not Confirmed
    • fda
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    Regulatory Info : RX

    Registration Country : USA

    OZANIMOD HYDROCHLORIDE

    Brand Name : ZEPOSIA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : EQ 0.46MG BASE

    Packaging :

    Approval Date : 2020-03-25

    Application Number : 209899

    Regulatory Info : RX

    Registration Country : USA

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    06

    Bristol Laboratories Ltd

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    Bristol Laboratories Ltd

    United Kingdom
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    SupplySide West 2024
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    OZANIMOD HYDROCHLORIDE

    Brand Name : ZEPOSIA

    Dosage Form : CAPSULE;ORAL

    Dosage Strength : EQ 0.92MG BASE

    Packaging :

    Approval Date : 2020-03-25

    Application Number : 209899

    Regulatory Info : RX

    Registration Country : USA

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    07

    Bristol Myers Squibb

    U.S.A
    SupplySide West 2024
    Not Confirmed
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    Bristol Myers Squibb

    U.S.A
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    SupplySide West 2024
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Ozanimodum

    Brand Name : Zeposia

    Dosage Form : Caps

    Dosage Strength : 0.92mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    08

    Celgene Corporation

    U.S.A
    SupplySide West 2024
    Not Confirmed
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    Celgene Corporation

    U.S.A
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    SupplySide West 2024
    Not Confirmed
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    Regulatory Info :

    Registration Country : Australia

    ozanimod

    Brand Name : Zeposia

    Dosage Form :

    Dosage Strength :

    Packaging : 28

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    09

    Celgene Corporation

    U.S.A
    SupplySide West 2024
    Not Confirmed
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    Celgene Corporation

    U.S.A
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    SupplySide West 2024
    Not Confirmed
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    Regulatory Info :

    Registration Country : Australia

    ozanimod

    Brand Name : Zeposia

    Dosage Form :

    Dosage Strength :

    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    10

    Celgene Corporation

    U.S.A
    SupplySide West 2024
    Not Confirmed
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    Celgene Corporation

    U.S.A
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    SupplySide West 2024
    Not Confirmed
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    Regulatory Info :

    Registration Country : Australia

    ozanimod

    Brand Name : Zeposia

    Dosage Form :

    Dosage Strength :

    Packaging : 1

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Iran.png
    Ozanimod Hydrochloride API needed in Iran [ENA14464]
    A company that specializes in development and manufacturing of oncology, neurology, rheumatology and other products is looking for suppliers of Ozanimod Hydrochloride API for development purpose.
    26 Jul 2022

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    26 Jul 2022

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    26 Jul 2022

    Egypt.png
    Various APIs needed in Egypt [ENA08656]
    A pharmaceutical manufacturing company that deals in various finished dosage formulations is looking for suppliers of Various APIs. The suppliers must support this enquiry with GMP. 1. Levonordefrin (MOQ) API 2. Vernakalant Hydrochloride (1 g) API 3. S-Amlodipine Besylate (1 g) API 4. Lemborexant (MOQ) API 5. Pancreatin (MOQ) API 6. Opicapone (MOQ) API 7. Ozanimod (MOQ) API
    26 Sep 2020

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    26 Sep 2020

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    Reply Comment (13)

    26 Sep 2020

    Egypt.png
    Ozanimod (MOQ) API needed in Egypt [ENA07556]
    ED Pharma, a company that deals in various pharmaceutical products is looking for suppliers of Ozanimod (MOQ) API. The suppliers must support this enquiry with CoA. Interested suppliers can contact them via their email id: edpharma@yahoo.com.
    12 Jun 2020

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    12 Jun 2020

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    Reply Comment (5)

    12 Jun 2020

    india-flag.png
    Various APIs needed in India [ENA07532]
    Poonam Pharma, a distributor based in India is looking for suppliers of Various APIs. The required quantity is 5 kg each. Interested suppliers can contact them via their email id: purchase.poonam@gmail.com. 1. Cenobamate 2. Ozanimod 3. Omadacycline Tosylate 4. Valbenazine Tosylate 5. Sarecycline HCl 6. Deutetrabenazine 7. Sodium Oxybate 8. Lasmiditan Hemisuccinate
    10 Jun 2020

    Reply

    10 Jun 2020

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    Reply Comment (6)

    10 Jun 2020

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