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    Chemistry

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    Also known as:
    Molecular Formula
    C17H20N4S
    Molecular Weight
    312.4  g/mol
    InChI Key
    WXPNDRBBWZMPQG-UHFFFAOYSA-N
    Olanzapine
    1 2D Structure

    Olanzapine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[3,2-c][1,5]benzodiazepine
    2.1.2 InChI
    InChI=1S/C17H20N4S/c1-12-11-13-16(21-9-7-20(2)8-10-21)18-14-5-3-4-6-15(14)19-17(13)22-12/h3-6,11,18H,7-10H2,1-2H3
    2.1.3 InChI Key
    WXPNDRBBWZMPQG-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=CC2=C(NC3=CC=CC=C3N=C2S1)N4CCN(CC4)C
    2.1.5 Isomeric SMILES
    CC1=CC2=C(NC3=CC=CC=C3N=C2S1)N4CCN(CC4)C
    2.2 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 312.4 g/mol
    Molecular Formula C17H20N4S
    XLogP32.8
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count1
    Exact Mass312.14086783 g/mol
    Monoisotopic Mass312.14086783 g/mol
    Topological Polar Surface Area56.2 A^2
    Heavy Atom Count22
    Formal Charge0
    Complexity543
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 8  
    Drug NameOlanzapine
    PubMed HealthOlanzapine
    Drug ClassesAntipsychotic
    Drug LabelOlanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a...
    Active IngredientOlanzapine
    Dosage FormTablet; Injectable; Tablet, orally disintegrating
    Routeoral; Oral; Intramuscular
    Strength2.5mg; 10mg/vial; 7.5mg; 15mg; 5mg; 10mg; 20mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Apotex; Aurobindo Pharma; Sun Pharm Inds; Torrent Pharms; Barr Labs; Sandoz; Par Pharm; Roxane; Teva Pharms; Macleods Pharms; Jubilant Generics; Luitpold; Dr Reddys Labs; Orchid Hlthcare; Mylan

    2 of 8  
    Drug NameSymbyax
    PubMed HealthOlanzapine/Fluoxetine (By mouth)
    Drug ClassesAntidepressant, Antipsychotic
    Active IngredientFluoxetine hydrochloride; olanzapine
    Dosage FormCapsule
    RouteOral
    Strengtheq 50mg base; eq 6mg base; eq 12mg base; eq 3mg base; eq 25mg base
    Market StatusPrescription
    CompanyLilly

    3 of 8  
    Drug NameZyprexa
    Drug LabelZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresp...
    Active IngredientOlanzapine
    Dosage FormTablet; Injectable
    RouteOral; Intramuscular
    Strength2.5mg; 10mg/vial; 7.5mg; 15mg; 5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyLilly

    4 of 8  
    Drug NameZyprexa zydis
    Drug LabelZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresp...
    Active IngredientOlanzapine
    Dosage FormTablet, orally disintegrating
    RouteOral
    Strength15mg; 5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyLilly

    5 of 8  
    Drug NameOlanzapine
    PubMed HealthOlanzapine
    Drug ClassesAntipsychotic
    Drug LabelOlanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a...
    Active IngredientOlanzapine
    Dosage FormTablet; Injectable; Tablet, orally disintegrating
    Routeoral; Oral; Intramuscular
    Strength2.5mg; 10mg/vial; 7.5mg; 15mg; 5mg; 10mg; 20mg
    Market StatusTentative Approval; Prescription
    CompanyMylan Pharms; Apotex; Aurobindo Pharma; Sun Pharm Inds; Torrent Pharms; Barr Labs; Sandoz; Par Pharm; Roxane; Teva Pharms; Macleods Pharms; Jubilant Generics; Luitpold; Dr Reddys Labs; Orchid Hlthcare; Mylan

    6 of 8  
    Drug NameSymbyax
    PubMed HealthOlanzapine/Fluoxetine (By mouth)
    Drug ClassesAntidepressant, Antipsychotic
    Active IngredientFluoxetine hydrochloride; olanzapine
    Dosage FormCapsule
    RouteOral
    Strengtheq 50mg base; eq 6mg base; eq 12mg base; eq 3mg base; eq 25mg base
    Market StatusPrescription
    CompanyLilly

    7 of 8  
    Drug NameZyprexa
    Drug LabelZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresp...
    Active IngredientOlanzapine
    Dosage FormTablet; Injectable
    RouteOral; Intramuscular
    Strength2.5mg; 10mg/vial; 7.5mg; 15mg; 5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyLilly

    8 of 8  
    Drug NameZyprexa zydis
    Drug LabelZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresp...
    Active IngredientOlanzapine
    Dosage FormTablet, orally disintegrating
    RouteOral
    Strength15mg; 5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyLilly

    API Reference Price

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    04-Jan-2022
    28-Feb-2026
    KGS
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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 5MG

    USFDA APPLICATION NUMBER - 21086

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    ABOUT THIS PAGE

    Looking for / Olanzapine API manufacturers, exporters & distributors?

    Olanzapine manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Olanzapine

    Zolafren Manufacturers

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

    Zolafren Suppliers

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

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

    Zolafren USDMF

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

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

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

    Zolafren 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 Zolafren Drug Master File in Japan (Zolafren JDMF) empowers Zolafren 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 Zolafren JDMF during the approval evaluation for pharmaceutical products. At the time of Zolafren 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 Zolafren suppliers with JDMF on PharmaCompass.

    Zolafren KDMF

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

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

    After submitting a Zolafren 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 Zolafren API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Zolafren suppliers with KDMF on PharmaCompass.

    Zolafren CEP

    A Zolafren CEP of the European Pharmacopoeia monograph is often referred to as a Zolafren Certificate of Suitability (COS). The purpose of a Zolafren CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zolafren EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zolafren to their clients by showing that a Zolafren CEP has been issued for it. The manufacturer submits a Zolafren CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zolafren CEP holder for the record. Additionally, the data presented in the Zolafren CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zolafren DMF.

    A Zolafren CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zolafren CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Zolafren suppliers with CEP (COS) on PharmaCompass.

    Zolafren WC

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

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

    Zolafren 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 Zolafren as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Zolafren 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 Zolafren 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 Zolafren and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zolafren NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Zolafren suppliers with NDC on PharmaCompass.

    Zolafren GMP

    Zolafren 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 Zolafren 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 Zolafren GMP manufacturer or Zolafren GMP API supplier for your needs.

    Zolafren CoA

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

    Zolafren CoA mostly includes findings from lab analyses of a specific batch. For each Zolafren 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.

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