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| Molecular Weight | 312.4 g/mol |
|---|---|
| Molecular Formula | C17H20N4S |
| XLogP3 | 2.8 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 1 |
| Exact Mass | 312.14086783 g/mol |
| Monoisotopic Mass | 312.14086783 g/mol |
| Topological Polar Surface Area | 56.2 A^2 |
| Heavy Atom Count | 22 |
| Formal Charge | 0 |
| Complexity | 543 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 8 | |
|---|---|
| Drug Name | Olanzapine |
| PubMed Health | Olanzapine |
| Drug Classes | Antipsychotic |
| Drug Label | 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 corresponds to a... |
| Active Ingredient | Olanzapine |
| Dosage Form | Tablet; Injectable; Tablet, orally disintegrating |
| Route | oral; Oral; Intramuscular |
| Strength | 2.5mg; 10mg/vial; 7.5mg; 15mg; 5mg; 10mg; 20mg |
| Market Status | Tentative Approval; Prescription |
| Company | Mylan 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 Name | Symbyax |
| PubMed Health | Olanzapine/Fluoxetine (By mouth) |
| Drug Classes | Antidepressant, Antipsychotic |
| Active Ingredient | Fluoxetine hydrochloride; olanzapine |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | eq 50mg base; eq 6mg base; eq 12mg base; eq 3mg base; eq 25mg base |
| Market Status | Prescription |
| Company | Lilly |
| 3 of 8 | |
|---|---|
| Drug Name | Zyprexa |
| Drug Label | ZYPREXA (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 Ingredient | Olanzapine |
| Dosage Form | Tablet; Injectable |
| Route | Oral; Intramuscular |
| Strength | 2.5mg; 10mg/vial; 7.5mg; 15mg; 5mg; 10mg; 20mg |
| Market Status | Prescription |
| Company | Lilly |
| 4 of 8 | |
|---|---|
| Drug Name | Zyprexa zydis |
| Drug Label | ZYPREXA (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 Ingredient | Olanzapine |
| Dosage Form | Tablet, orally disintegrating |
| Route | Oral |
| Strength | 15mg; 5mg; 10mg; 20mg |
| Market Status | Prescription |
| Company | Lilly |
| 5 of 8 | |
|---|---|
| Drug Name | Olanzapine |
| PubMed Health | Olanzapine |
| Drug Classes | Antipsychotic |
| Drug Label | 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 corresponds to a... |
| Active Ingredient | Olanzapine |
| Dosage Form | Tablet; Injectable; Tablet, orally disintegrating |
| Route | oral; Oral; Intramuscular |
| Strength | 2.5mg; 10mg/vial; 7.5mg; 15mg; 5mg; 10mg; 20mg |
| Market Status | Tentative Approval; Prescription |
| Company | Mylan 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 Name | Symbyax |
| PubMed Health | Olanzapine/Fluoxetine (By mouth) |
| Drug Classes | Antidepressant, Antipsychotic |
| Active Ingredient | Fluoxetine hydrochloride; olanzapine |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | eq 50mg base; eq 6mg base; eq 12mg base; eq 3mg base; eq 25mg base |
| Market Status | Prescription |
| Company | Lilly |
| 7 of 8 | |
|---|---|
| Drug Name | Zyprexa |
| Drug Label | ZYPREXA (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 Ingredient | Olanzapine |
| Dosage Form | Tablet; Injectable |
| Route | Oral; Intramuscular |
| Strength | 2.5mg; 10mg/vial; 7.5mg; 15mg; 5mg; 10mg; 20mg |
| Market Status | Prescription |
| Company | Lilly |
| 8 of 8 | |
|---|---|
| Drug Name | Zyprexa zydis |
| Drug Label | ZYPREXA (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 Ingredient | Olanzapine |
| Dosage Form | Tablet, orally disintegrating |
| Route | Oral |
| Strength | 15mg; 5mg; 10mg; 20mg |
| Market Status | Prescription |
| Company | Lilly |
API SUPPLIERS
Inke S.A: APIs manufacturing plant.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-03
Pay. Date : 2013-01-23
DMF Number : 26694
Submission : 2013-01-24
Status : Active
Type : II
NDC Package Code : 64567-0017
Start Marketing Date : 2013-01-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-11-13
Registration Number : 20201113-209-J-568
Manufacturer Name : INKE SA
Manufacturer Address : C/Argent, 1. Area Industrial del Llobregat, 08755 Castellbisbal (Barcelona), Spain
| Available Reg Filing : ASMF |
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Jai Radhe Sales is your partner for all your sourcing needs.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-18
Pay. Date : 2014-02-10
DMF Number : 20218
Submission : 2007-01-29
Status : Active
Type : II
Date of Issue : 2025-04-24
Valid Till : 2028-05-25
Written Confirmation Number : WC-0002
Address of the Firm :
NDC Package Code : 15894-0006
Start Marketing Date : 2019-07-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-06-11
Registration Number : 20200611-209-J-402
Manufacturer Name : Teva API India Private Limited
Manufacturer Address : Plot No, A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Gajraula, Distt. Amroha (UP) India
| Available Reg Filing : CA, ASMF |
Qingmu Pharma: Patients first, FDA/CEP/US-DMF/US-VMF/ASMF APIs for Humans & Vets in 100+ countries.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40035
Submission : 2025-04-02
Status : Active
Type : II
| Available Reg Filing : CA, ASMF |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-03
Pay. Date : 2013-09-23
DMF Number : 26763
Submission : 2012-12-28
Status : Active
Type : II
Certificate Number : R1-CEP 2012-406 - Rev 01
Issue Date : 2023-07-20
Type : Chemical
Substance Number : 2258
Status : Valid
NDC Package Code : 49587-103
Start Marketing Date : 2014-12-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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USDMF
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-03
Pay. Date : 2013-01-23
DMF Number : 26694
Submission : 2013-01-24
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-18
Pay. Date : 2014-02-10
DMF Number : 20218
Submission : 2007-01-29
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40035
Submission : 2025-04-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15052
Submission : 2000-09-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20354
Submission : 2007-03-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-13
Pay. Date : 2021-07-09
DMF Number : 18260
Submission : 2005-04-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18108
Submission : 2005-02-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18867
Submission : 2005-10-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19168
Submission : 2006-02-10
Status : Inactive
Type : II
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Average Price (USD/KGS) |
Number of Transactions |
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Drugs in Development
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DOSAGE - TABLET;ORAL - 10MG
USFDA APPLICATION NUMBER - 20592
DOSAGE - TABLET;ORAL - 15MG
USFDA APPLICATION NUMBER - 20592
DOSAGE - TABLET;ORAL - 2.5MG
USFDA APPLICATION NUMBER - 20592
DOSAGE - TABLET;ORAL - 20MG
USFDA APPLICATION NUMBER - 20592
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 20592
DOSAGE - TABLET;ORAL - 7.5MG
USFDA APPLICATION NUMBER - 20592
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 10MG
USFDA APPLICATION NUMBER - 21086
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 15MG
USFDA APPLICATION NUMBER - 21086
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 20MG
USFDA APPLICATION NUMBER - 21086
DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 5MG
USFDA APPLICATION NUMBER - 21086
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
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Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
Company : Alkermes Inc
Olanzapine/Samidorphan Malate
Drug Cost (USD) : 89,971,771
Year : 2023
Prescribers : 9246
Prescriptions : 56531
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Company : Apotex Corp
Olanzapine
Drug Cost (USD) : 7,619,943
Year : 2023
Prescribers : 16546
Prescriptions : 65909
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Company : Aurobindo Pharm
Olanzapine
Drug Cost (USD) : 7,553
Year : 2023
Prescribers : 34
Prescriptions : 125
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Company : Dr.Reddy'S Lab
Olanzapine
Drug Cost (USD) : 2,219,559
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Prescriptions : 33388
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Company : Jubilant Cadist
Olanzapine
Drug Cost (USD) : 718,829
Year : 2023
Prescribers : 1548
Prescriptions : 5352
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Company : Macleods Pharma
Olanzapine
Drug Cost (USD) : 8,366,016
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Prescribers : 15834
Prescriptions : 63421
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Olanzapine
Drug Cost (USD) : 3,026,088
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Prescriptions : 21036
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Olanzapine
Drug Cost (USD) : 122,185
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Prescribers : 501
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ABOUT THIS PAGE
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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.
A Symbyax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Symbyax, including repackagers and relabelers. The FDA regulates Symbyax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Symbyax 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 Symbyax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Symbyax supplier is an individual or a company that provides Symbyax active pharmaceutical ingredient (API) or Symbyax finished formulations upon request. The Symbyax suppliers may include Symbyax API manufacturers, exporters, distributors and traders.
click here to find a list of Symbyax suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Symbyax DMF (Drug Master File) is a document detailing the whole manufacturing process of Symbyax active pharmaceutical ingredient (API) in detail. Different forms of Symbyax DMFs exist exist since differing nations have different regulations, such as Symbyax USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Symbyax DMF submitted to regulatory agencies in the US is known as a USDMF. Symbyax USDMF includes data on Symbyax's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Symbyax USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Symbyax suppliers with USDMF on PharmaCompass.
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 Symbyax Drug Master File in Japan (Symbyax JDMF) empowers Symbyax 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 Symbyax JDMF during the approval evaluation for pharmaceutical products. At the time of Symbyax 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 Symbyax suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Symbyax Drug Master File in Korea (Symbyax KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Symbyax. The MFDS reviews the Symbyax KDMF as part of the drug registration process and uses the information provided in the Symbyax KDMF to evaluate the safety and efficacy of the drug.
After submitting a Symbyax 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 Symbyax API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Symbyax suppliers with KDMF on PharmaCompass.
A Symbyax CEP of the European Pharmacopoeia monograph is often referred to as a Symbyax Certificate of Suitability (COS). The purpose of a Symbyax CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Symbyax EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Symbyax to their clients by showing that a Symbyax CEP has been issued for it. The manufacturer submits a Symbyax CEP (COS) as part of the market authorization procedure, and it takes on the role of a Symbyax CEP holder for the record. Additionally, the data presented in the Symbyax CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Symbyax DMF.
A Symbyax CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Symbyax 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 Symbyax suppliers with CEP (COS) on PharmaCompass.
A Symbyax written confirmation (Symbyax WC) is an official document issued by a regulatory agency to a Symbyax manufacturer, verifying that the manufacturing facility of a Symbyax active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Symbyax APIs or Symbyax finished pharmaceutical products to another nation, regulatory agencies frequently require a Symbyax WC (written confirmation) as part of the regulatory process.
click here to find a list of Symbyax suppliers with Written Confirmation (WC) on PharmaCompass.
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 Symbyax as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Symbyax API and other APIs are published in this directory by the FDA.
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 Symbyax 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.
The NDC directory also contains data on finished compounded human drug products that contain Symbyax and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Symbyax NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Symbyax suppliers with NDC on PharmaCompass.
Symbyax 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 Symbyax 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 Symbyax GMP manufacturer or Symbyax GMP API supplier for your needs.
A Symbyax CoA (Certificate of Analysis) is a formal document that attests to Symbyax's compliance with Symbyax specifications and serves as a tool for batch-level quality control.
Symbyax CoA mostly includes findings from lab analyses of a specific batch. For each Symbyax 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.
Symbyax may be tested according to a variety of international standards, such as European Pharmacopoeia (Symbyax EP), Symbyax JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Symbyax USP).
