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    Also known as: Lurasidone hcl, 367514-88-3, Latuda, Sm-13496, Lurasidone hydrochloride [usan], Sm 13496
    Molecular Formula
    C28H37ClN4O2S
    Molecular Weight
    529.1  g/mol
    InChI Key
    NEKCRUIRPWNMLK-SCIYSFAVSA-N
    FDA UNII
    O0P4I5851I
    Lurasidone Hydrochloride
    A thiazole derivative and atypical ANTIPSYCHOTIC AGENT that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST; SEROTONIN 5-HT2 RECEPTOR ANTAGONIST, serotonin 5-HT7 receptor antagonist, and antagonist of the adrenergic 2A and 2C receptors, as well as a partial SEROTONIN 5-HT1A RECEPTOR AGONIST. It is used in the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER.
    1 2D Structure

    Lurasidone Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1S,2R,6S,7R)-4-[[(1R,2R)-2-[[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl]cyclohexyl]methyl]-4-azatricyclo[5.2.1.02,6]decane-3,5-dione;hydrochloride
    2.1.2 InChI
    InChI=1S/C28H36N4O2S.ClH/c33-27-24-18-9-10-19(15-18)25(24)28(34)32(27)17-21-6-2-1-5-20(21)16-30-11-13-31(14-12-30)26-22-7-3-4-8-23(22)35-29-26;/h3-4,7-8,18-21,24-25H,1-2,5-6,9-17H2;1H/t18-,19+,20-,21-,24+,25-;/m0./s1
    2.1.3 InChI Key
    NEKCRUIRPWNMLK-SCIYSFAVSA-N
    2.1.4 Canonical SMILES
    C1CCC(C(C1)CN2CCN(CC2)C3=NSC4=CC=CC=C43)CN5C(=O)C6C7CCC(C7)C6C5=O.Cl
    2.1.5 Isomeric SMILES
    C1CC[C@H]([C@@H](C1)CN2CCN(CC2)C3=NSC4=CC=CC=C43)CN5C(=O)[C@H]6[C@@H]7CC[C@@H](C7)[C@H]6C5=O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    O0P4I5851I
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 13496, Sm

    2. Hcl, Lurasidone

    3. Hydrochloride, Lurasidone

    4. Latuda

    5. Lurasidone

    6. Lurasidone Hcl

    7. N-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinylmethyl)-1-cyclohexylmethyl)-2,3-bicyclo(2.2.1)heptanedicarboximide

    8. Sm 13,496

    9. Sm 13496

    10. Sm-13,496

    11. Sm-13496

    12. Sm13,496

    13. Sm13496

    2.3.2 Depositor-Supplied Synonyms

    1. Lurasidone Hcl

    2. 367514-88-3

    3. Latuda

    4. Sm-13496

    5. Lurasidone Hydrochloride [usan]

    6. Sm 13496

    7. Chebi:70732

    8. O0p4i5851i

    9. Lurasidonhydrochloride

    10. (1s,2r,6s,7r)-4-[[(1r,2r)-2-[[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl]cyclohexyl]methyl]-4-azatricyclo[5.2.1.02,6]decane-3,5-dione;hydrochloride

    11. (3ar,4s,7r,7as)-2-(((1r,2r)-2-((4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)methyl)cyclohexyl)methyl)hexahydro-1h-4,7-methanoisoindole-1,3(2h)-dione Hydrochloride

    12. (1r,2s,6r,7s)-4-{[(1r,2r)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}-4-azatricyclo[5.2.1.0^{2,6}]decane-3,5-dione Hydrochloride

    13. 4,7-methano-1h-isoindole-1,3(2h)-dione, 2-(((1r,2r)-2-((4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)methyl)cyclohexyl)methyl)hexahydro-, Monohydrochloride, (3ar,4s,7r,7as)-

    14. Unii-o0p4i5851i

    15. Latuda (tn)

    16. Lurasidone Monohydrochloride

    17. Lurasidone-d8 Hydrochloride

    18. Sm-13496 (hydrochloride)

    19. Schembl1534132

    20. Chembl1615372

    21. Dtxsid401027714

    22. Lurasidone Hydrochloride (jan/usan)

    23. Lurasidone Hydrochloride [mi]

    24. S3044

    25. Smp-13496

    26. Lurasidone Hydrochloride [jan]

    27. Akos022185856

    28. Ex-3125

    29. Mk-3756

    30. Lurasidone Hydrochloride [mart.]

    31. Lurasidone Hydrochloride [vandf]

    32. Lurasidone Hydrochloride [who-dd]

    33. As-35074

    34. Lurasidone Hydrochloride, >=98% (hplc)

    35. Lurasidone Hydrochloride [orange Book]

    36. D04820

    37. Q27882070

    38. (3ar,4s,7r,7as)-2-((1r,2r)-2-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl)cyclohexylmethyl)hexahydro-4,7-methano-2h-isoindole-1,3-dione, Hydrochloride

    39. (3ar,4s,7r,7as)-2-{(1r,2r)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl]cyclohexylmethyl}hexahydro-4,7-methano-2h-isoindole-1,3-dione Hydrochloride

    40. (3ar,4s,7r,7as)-2-{[(1r,2r)-2-{[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]methyl}cyclohexyl]methyl}hexahydro-1h-4,7-methanoisoindole-1,3(2h)-dione Hydrochloride

    41. 4-(1,2-benzothiazol-3-yl)-1-{[(1r,2r)-2-{[(3ar,4s,7r,7as)-1,3-dioxooctahydro-2h-4,7-methanoisoindol-2-yl]methyl}cyclohexyl]methyl}piperazin-1-ium Chloride

    42. Lurasidone Hydrochloride Solution, 1.0 Mg/ml In Methanol (as Free Base), Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2006-10-26
    3 Chemical and Physical Properties
    Molecular Weight 529.1 g/mol
    Molecular Formula C28H37ClN4O2S
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count5
    Exact Mass528.2325753 g/mol
    Monoisotopic Mass528.2325753 g/mol
    Topological Polar Surface Area85 Ų
    Heavy Atom Count36
    Formal Charge0
    Complexity804
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameLatuda
    PubMed HealthLurasidone (By mouth)
    Drug ClassesAntipsychotic, Central Nervous System Agent
    Drug LabelLATUDA is a psychotropic agent belonging to the chemical class of benzoisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3...
    Active IngredientLurasidone hydrochloride
    Dosage FormTablet
    RouteOral
    Strength120mg; 60mg; 80mg; 40mg; 20mg
    Market StatusPrescription
    CompanySunovion Pharms

    2 of 2  
    Drug NameLatuda
    PubMed HealthLurasidone (By mouth)
    Drug ClassesAntipsychotic, Central Nervous System Agent
    Drug LabelLATUDA is a psychotropic agent belonging to the chemical class of benzoisothiazol derivatives. Its chemical name is (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3...
    Active IngredientLurasidone hydrochloride
    Dosage FormTablet
    RouteOral
    Strength120mg; 60mg; 80mg; 40mg; 20mg
    Market StatusPrescription
    CompanySunovion Pharms

    4.2 Drug Indication

    Treatment of schizophrenia in adults aged 18 years and over.

    Treatment of schizophrenia

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Adrenergic alpha-2 Receptor Antagonists

    Drugs that bind to and block the activation of ADRENERGIC ALPHA-2 RECEPTORS. (See all compounds classified as Adrenergic alpha-2 Receptor Antagonists.)

    Antipsychotic Agents

    Agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect. They are used in SCHIZOPHRENIA; senile dementia; transient psychosis following surgery; or MYOCARDIAL INFARCTION; etc. These drugs are often referred to as neuroleptics alluding to the tendency to produce neurological side effects, but not all antipsychotics are likely to produce such effects. Many of these drugs may also be effective against nausea, emesis, and pruritus. (See all compounds classified as Antipsychotic Agents.)

    Dopamine D2 Receptor Antagonists

    Compounds and drugs that bind to and inhibit or block the activation of DOPAMINE D2 RECEPTORS. (See all compounds classified as Dopamine D2 Receptor Antagonists.)

    Serotonin 5-HT2 Receptor Antagonists

    Drugs that bind to but do not activate SEROTONIN 5-HT2 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT2 RECEPTOR AGONISTS. Included under this heading are antagonists for one or more specific 5-HT2 receptor subtypes. (See all compounds classified as Serotonin 5-HT2 Receptor Antagonists.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Atypical Antipsychotic [EPC]
    5.3 ATC Code

    N05AE05

    API Reference Price

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    03-Jan-2022
    25-Apr-2025
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    DOSAGE - TABLET;ORAL - 120MG

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

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

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

    API | Excipient name

    Lurasidone

    Synonyms

    Lurasidone hcl, 367514-88-3, Latuda, Sm-13496, Lurasidone hydrochloride [usan], Sm 13496

    Cas Number

    367514-88-3

    Unique Ingredient Identifier (UNII)

    O0P4I5851I

    About Lurasidone

    A thiazole derivative and atypical ANTIPSYCHOTIC AGENT that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST; SEROTONIN 5-HT2 RECEPTOR ANTAGONIST, serotonin 5-HT7 receptor antagonist, and antagonist of the adrenergic 2A and 2C receptors, as well as a partial SEROTONIN 5-HT1A RECEPTOR AGONIST. It is used in the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER.

    Lurasidone hydrochloride (USAN) Manufacturers

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

    Lurasidone hydrochloride (USAN) Suppliers

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

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

    Lurasidone hydrochloride (USAN) USDMF

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

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

    click here to find a list of Lurasidone hydrochloride (USAN) suppliers with USDMF on PharmaCompass.

    Lurasidone hydrochloride (USAN) JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Lurasidone hydrochloride (USAN) Drug Master File in Japan (Lurasidone hydrochloride (USAN) JDMF) empowers Lurasidone hydrochloride (USAN) API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Lurasidone hydrochloride (USAN) JDMF during the approval evaluation for pharmaceutical products. At the time of Lurasidone hydrochloride (USAN) JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Lurasidone hydrochloride (USAN) suppliers with JDMF on PharmaCompass.

    Lurasidone hydrochloride (USAN) KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Lurasidone hydrochloride (USAN) Drug Master File in Korea (Lurasidone hydrochloride (USAN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lurasidone hydrochloride (USAN). The MFDS reviews the Lurasidone hydrochloride (USAN) KDMF as part of the drug registration process and uses the information provided in the Lurasidone hydrochloride (USAN) KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Lurasidone hydrochloride (USAN) KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Lurasidone hydrochloride (USAN) API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Lurasidone hydrochloride (USAN) suppliers with KDMF on PharmaCompass.

    Lurasidone hydrochloride (USAN) WC

    A Lurasidone hydrochloride (USAN) written confirmation (Lurasidone hydrochloride (USAN) WC) is an official document issued by a regulatory agency to a Lurasidone hydrochloride (USAN) manufacturer, verifying that the manufacturing facility of a Lurasidone hydrochloride (USAN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lurasidone hydrochloride (USAN) APIs or Lurasidone hydrochloride (USAN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Lurasidone hydrochloride (USAN) WC (written confirmation) as part of the regulatory process.

    click here to find a list of Lurasidone hydrochloride (USAN) suppliers with Written Confirmation (WC) on PharmaCompass.

    Lurasidone hydrochloride (USAN) NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Lurasidone hydrochloride (USAN) as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Lurasidone hydrochloride (USAN) API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Lurasidone hydrochloride (USAN) as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Lurasidone hydrochloride (USAN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lurasidone hydrochloride (USAN) NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Lurasidone hydrochloride (USAN) suppliers with NDC on PharmaCompass.

    Lurasidone hydrochloride (USAN) GMP

    Lurasidone hydrochloride (USAN) Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

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

    Lurasidone hydrochloride (USAN) CoA

    A Lurasidone hydrochloride (USAN) CoA (Certificate of Analysis) is a formal document that attests to Lurasidone hydrochloride (USAN)'s compliance with Lurasidone hydrochloride (USAN) specifications and serves as a tool for batch-level quality control.

    Lurasidone hydrochloride (USAN) CoA mostly includes findings from lab analyses of a specific batch. For each Lurasidone hydrochloride (USAN) CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Lurasidone hydrochloride (USAN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Lurasidone hydrochloride (USAN) EP), Lurasidone hydrochloride (USAN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lurasidone hydrochloride (USAN) USP).

    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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