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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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VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1683657000,"product":"OLANZAPINE USP BATCH NO COLU220001 0000058933 COLU220005","address":"NO. 9,215, PUDUPAKKAM - VANDALLUR, MAIN ROAD PUDUPAKKAM","city":"KANCHIPURAM","supplier":"ENDO VENTURES LTD","supplierCountry":"UNITED STATES","foreign_port":"NEW YORK JOHN F K","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"24.50","actualQuantity":"24.498","unit":"KGS","unitRateFc":"4400","totalValueFC":"108762","currency":"USD","unitRateINR":"365311.3","date":"10-May-2023","totalValueINR":"8949396.12","totalValueInUsd":"108762","indian_port":"MADRAS AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"United States","selfForZScoreResived":"Pharma Grade","supplierPort":"NEW YORK JOHN F K","supplierAddress":"","customerAddress":"NO. 9,215, PUDUPAKKAM - VANDALLUR, MAIN ROAD PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688495400,"product":"OLANZAPINE PH.EUR RE-IMPORT GOODS VIDE SB NO-7147897\/30-12-2021 & EXP INV-SI3621122894\/25.12.2021","address":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con","city":"HYDERABAD","supplier":"GEDEON RICHTER POLSKA SP ZOO","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS LTD","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"1800","totalValueFC":"37777.8","currency":"USD","unitRateINR":"155247","date":"05-Jul-2023","totalValueINR":"3104936.695","totalValueInUsd":"37777.8","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699036200,"product":"OLANZAPINE USP BATCH NO. 23OLZ002 (REJECTED QTY -REIMPORT)","address":"CADILA CORPORATE CAMPUS","city":"AHMEDABAD, GUJARAT","supplier":"JAZEERA PHARMACEUTICAL INDUSTRIES","supplierCountry":"INDIA","foreign_port":"RIYADH","customer":"CADILA PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"71.00","actualQuantity":"71","unit":"KGS","unitRateFc":"320","totalValueFC":"24522.4","currency":"EURO","unitRateINR":"28760.6","date":"04-Nov-2023","totalValueINR":"2042004.42","totalValueInUsd":"24522.4","indian_port":"Ahmedabad Air","hs_no":"29335990","bill_no":"8622899","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"RIYADH","supplierAddress":"A LIMITED LIABILITY COMPANYPO BOX 106229 RIYADH 11666SDNF SAUDI ARABIA","customerAddress":"CADILA CORPORATE CAMPUS"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700850600,"product":"OLANZAPINE FORM I(SB.NO.6549755 DATE:29.12.2022)","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"JOSWE MEDICAL","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"LEE PHARMA LTD","customerCountry":"INDIA","quantity":"49.50","actualQuantity":"49.5","unit":"KGS","unitRateFc":"1200","totalValueFC":"61747","currency":"USD","unitRateINR":"103873.3","date":"25-Nov-2023","totalValueINR":"5141726.83","totalValueInUsd":"61747","indian_port":"Madras Air","hs_no":"29349990","bill_no":"8942368","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBAI","supplierAddress":"JORDAN-SWEDEN MEDICAL& STERILIZATION CO. P.O.BOX.851831AMMAN JO","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1711564200,"product":"(REJECTED AND RETURN) OLANZAPINE (FORM - 1) -PH EUR, MFG DT:JA N- 2024, RETEST DT:DEC-2024, BATCH NO: OZ P2401004.S\/B#78","address":"PLOT NO.1-A SEC-16A","city":"NOIDA (U.P) INDIA","supplier":"SANOFI IIAC SAN VE TIC AS","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"JUBILANT PHARMOVA LTD","customerCountry":"INDIA","quantity":"17.90","actualQuantity":"17.9","unit":"KGS","unitRateFc":"1030","totalValueFC":"18651.1","currency":"USD","unitRateINR":"86520","date":"28-Mar-2024","totalValueINR":"1548708","totalValueInUsd":"18651.1","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"2789201","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBAI","supplierAddress":"ESENTEPE MAH. BUYUKDERE CAD, 193 APT NO:193\/14 SISLI ISTANBUL Istanbul, , Turkey Turkey","customerAddress":"PLOT NO.1-A SEC-16A"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715106600,"product":"OLANZAPINE","address":"SHANKAR TOWERS PLOT NO. A30,A.I.E","city":"HYDERABAD,TELANGANA","supplier":"ZHEJIANG SUPOR PHARMACEUTICALS CO","supplierCountry":"CHINA","foreign_port":"HONG KONG","customer":"ANTHEA PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"20000","totalValueFC":"60716.8","currency":"USD","unitRateINR":"1687000","date":"08-May-2024","totalValueINR":"5061000","totalValueInUsd":"60716.8","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"3386822","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"LTD. YUEDONG ROAD,PAOJIANG INDUSTRIAL ZONE,SHAOXING, ZHEJIANG 312071 CHINA","customerAddress":"SHANKAR TOWERS PLOT NO. A30,A.I.E"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716575400,"product":"OLANZAPINE ( RE-IMPORT CARGO EXPORTED VIDE S.B. NO. 5884880DATE 08.12.2023 )","address":"NO.201, DEVAVRATA SECTOR 17,,VASHI","city":"NAVI MUMBAI,MAHARASHTRA","supplier":"JIM ROYAL TRADING CO LTD","supplierCountry":"INDIA","foreign_port":"TAIPEI","customer":"SOLARA ACTIVE PHARMA SCIENCES LTD","customerCountry":"INDIA","quantity":"0.70","actualQuantity":"0.7","unit":"KGS","unitRateFc":"1800","totalValueFC":"1530.1","currency":"USD","unitRateINR":"182198.8","date":"25-May-2024","totalValueINR":"127539.19","totalValueInUsd":"1530.1","indian_port":"Madras Air","hs_no":"29420090","bill_no":"3663076","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"6th FLOOR, NO.341, SEC. 4th HSIN-YIROAD, TAIPEI, TAIWAN R.O.C.SDNF TAIWAN","customerAddress":"NO.201, DEVAVRATA SECTOR 17,,VASHI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730399400,"product":"OLANZAPINE FORM-I & W\/S BATCH NO: OB24006F1","address":"1017\/1018, CORPORATE AVENUE,,SONAW","city":"MUMBAI MAHARASHTRA,MAHARASHTRA","supplier":"ALARIS PHARMACEUTICALS PTE LTD","supplierCountry":"MYANMAR","foreign_port":"YANGON","customer":"DELTA BIOPHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"624.6","totalValueFC":"628.8","currency":"USD","unitRateINR":"53061.5","date":"01-Nov-2024","totalValueINR":"53061.47","totalValueInUsd":"628.8","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"6451462","productDescription":"API","marketType":"","country":"MYANMAR","selfForZScoreResived":"Pharma Grade","supplierPort":"YANGON","supplierAddress":"151 Chin Swee Road #03-16 Manhatta n House Singapore 169876 Ph: +65 91 93497 SINGAPORE","customerAddress":"1017\/1018, CORPORATE AVENUE,,SONAW"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736274600,"product":"(100% EOU) (FOC) OLANZAPINE ORO PLACEBO - BATCH.NOBK412\/121188 (FOR RESEARCH & TESTING PURPOSES ONLY)(100% EOU) (FOC) OLANZAPINE ORO PLACEBO - BATCH.NOBK412\/1211","address":"210 - 210A, GALLERIA, HIRANANDANI","city":"MUMBAI, MAHARASHTRA","supplier":"ACTAVIS LTD BLB016","supplierCountry":"MALTA","foreign_port":"MALTA","customer":"ACTAVIS PHARMA DEVELOPMENT CENTRE PRIVATE LTD","customerCountry":"INDIA","quantity":"0.07","actualQuantity":"70","unit":"GMS","unitRateFc":"0.2","totalValueFC":"17","currency":"EURO","unitRateINR":"21","date":"08-Jan-2025","totalValueINR":"1470.04","totalValueInUsd":"17","indian_port":"Madras Air","hs_no":"29349990","bill_no":"7680626","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"BULEBEL INDUSTRIAL ESTATE ZEJTUN , MALTA , MALTA","customerAddress":"210 - 210A, GALLERIA, HIRANANDANI"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740162600,"product":"OLANZAPINE (FOR TESTING PURPOSE ONLY)(FOC)(NO REMITTANCE INVOLVED)OLANZAPINE (FOR TESTING PURPOSE ONLY)","address":"M-34, SAKET,","city":"NEW DELHI,DELHI","supplier":"PLIVA CROATIA LTD","supplierCountry":"CROATIA","foreign_port":"ZAGREB","customer":"TEVA API INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.38","actualQuantity":"375","unit":"GMS","unitRateFc":"0.7","totalValueFC":"272.4","currency":"USD","unitRateINR":"63.2","date":"22-Feb-2025","totalValueINR":"23692.5","totalValueInUsd":"272.4","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"8509981","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZAGREB","supplierAddress":"TEVA PHARMACEUTICAL INDUSTRIES LTD. TEVA API DIVISION PRILAZ BARUNA FILIPOVICA 25, 10000 ZAGREB CROATIA","customerAddress":"M-34, SAKET,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741372200,"product":"OLANZAPINE FORM-1(RE IMPORT SB NO.2335187 DATE.11.07.2024) ORGANIC CHEMICALS","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"SUANFARMASAU","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"LEE PHARMA LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"815.9","totalValueFC":"41349.8","currency":"USD","unitRateINR":"71632.5","date":"08-Mar-2025","totalValueINR":"3581624","totalValueInUsd":"41349.8","indian_port":"Madras Air","hs_no":"29349990","bill_no":"8775659","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"CALLE EINSTEIN ,8-28108 ALCOBENDAS MADRID (SPAIN) ES","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"}]
    08-Jan-2022
    30-Jun-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 10MG

    USFDA APPLICATION NUMBER - 20592

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    DOSAGE - TABLET;ORAL - 15MG

    USFDA APPLICATION NUMBER - 20592

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    DOSAGE - TABLET;ORAL - 2.5MG

    USFDA APPLICATION NUMBER - 20592

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    DOSAGE - TABLET;ORAL - 20MG

    USFDA APPLICATION NUMBER - 20592

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    DOSAGE - TABLET;ORAL - 5MG

    USFDA APPLICATION NUMBER - 20592

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    DOSAGE - TABLET;ORAL - 7.5MG

    USFDA APPLICATION NUMBER - 20592

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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 10MG

    USFDA APPLICATION NUMBER - 21086

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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 15MG

    USFDA APPLICATION NUMBER - 21086

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    DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 20MG

    USFDA APPLICATION NUMBER - 21086

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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

    Apsico Manufacturers

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

    Apsico Suppliers

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

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

    Apsico USDMF

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

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

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

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

    Apsico KDMF

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

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

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

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

    Apsico CEP

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

    A Apsico CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Apsico 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 Apsico suppliers with CEP (COS) on PharmaCompass.

    Apsico WC

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

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

    Apsico 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 Apsico as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Apsico GMP

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

    Apsico CoA

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

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

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