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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
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USDMF
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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Date of Issue : 2025-04-24
Valid Till : 2028-05-25
Written Confirmation Number : WC-0002
Address of the Firm : Plot No. A-2, A-2/1, A-/2, UPSIDC Industrial Area, Bijnor Road, Gajraula -244235...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
Date of Issue : 2022-06-15
Valid Till : 2025-07-28
Written Confirmation Number : WC-0186
Address of the Firm : Sy No.10/G-1, Gaddapotharam (V), Jinnaram (M), Sangareddy District, Pincode 5023...
Date of Issue : 2022-06-06
Valid Till : 2025-06-10
Written Confirmation Number : WC-0017
Address of the Firm : Unit-II, SurveyNo.:10&13,Gaddapotharam (Village), IDA-Kazipally, Jinnaram (Manda...
Date of Issue : 2022-09-01
Valid Till : 2025-07-02
Written Confirmation Number : WC-0074Amended
Address of the Firm : 294, GIDC Estate Ankleshwar, Bharuch-393002, Gujarat India
Date of Issue : 2022-04-07
Valid Till : 2025-03-07
Written Confirmation Number : WC-0040n
Address of the Firm : Sy. No. 213, 214 & 255, Bonthapally Village, Gummadidala Mandai, Sangareddy Dist...
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0091n
Address of the Firm : P.O. Sejavta, Dist. Ratlam, Madhya Pradesh, India.
Date of Issue : 2023-09-14
Valid Till : 2025-05-06
Written Confirmation Number : WC-0026
Address of the Firm : Plot No. 9/A, Phase-lll, Jeedimetla Village, Quthbullapur Mandal, Medchal-Malkaj...
Date of Issue : 2023-09-14
Valid Till : 2025-05-06
Written Confirmation Number : WC-0026
Address of the Firm : Plot No. 9/A, Phase-lll, Jeedimetla Village, Quthbullapur Mandal, Medchal-Malkaj...
Date of Issue : 2022-09-07
Valid Till : 2025-07-02
Written Confirmation Number : WC-0079
Address of the Firm : Plot No. - 2209, G.I.D.C., Sarigam - 396 155, Dist - Valsad, Gujarat, India
Date of Issue : 2022-05-02
Valid Till : 2025-07-25
Written Confirmation Number : WC-0027A4a
Address of the Firm : Sy. No. 14, Gaddapotharam Village, IDA, Kazipally, Jinnaram Mandal, Sangareddy D...
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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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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 olanzapina manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of olanzapina, including repackagers and relabelers. The FDA regulates olanzapina manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. olanzapina 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 olanzapina manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A olanzapina supplier is an individual or a company that provides olanzapina active pharmaceutical ingredient (API) or olanzapina finished formulations upon request. The olanzapina suppliers may include olanzapina API manufacturers, exporters, distributors and traders.
click here to find a list of olanzapina suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A olanzapina DMF (Drug Master File) is a document detailing the whole manufacturing process of olanzapina active pharmaceutical ingredient (API) in detail. Different forms of olanzapina DMFs exist exist since differing nations have different regulations, such as olanzapina USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A olanzapina DMF submitted to regulatory agencies in the US is known as a USDMF. olanzapina USDMF includes data on olanzapina's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The olanzapina USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of olanzapina 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 olanzapina Drug Master File in Japan (olanzapina JDMF) empowers olanzapina 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 olanzapina JDMF during the approval evaluation for pharmaceutical products. At the time of olanzapina 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 olanzapina 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 olanzapina Drug Master File in Korea (olanzapina KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of olanzapina. The MFDS reviews the olanzapina KDMF as part of the drug registration process and uses the information provided in the olanzapina KDMF to evaluate the safety and efficacy of the drug.
After submitting a olanzapina 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 olanzapina API can apply through the Korea Drug Master File (KDMF).
click here to find a list of olanzapina suppliers with KDMF on PharmaCompass.
A olanzapina CEP of the European Pharmacopoeia monograph is often referred to as a olanzapina Certificate of Suitability (COS). The purpose of a olanzapina CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of olanzapina EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of olanzapina to their clients by showing that a olanzapina CEP has been issued for it. The manufacturer submits a olanzapina CEP (COS) as part of the market authorization procedure, and it takes on the role of a olanzapina CEP holder for the record. Additionally, the data presented in the olanzapina CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the olanzapina DMF.
A olanzapina CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. olanzapina 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 olanzapina suppliers with CEP (COS) on PharmaCompass.
A olanzapina written confirmation (olanzapina WC) is an official document issued by a regulatory agency to a olanzapina manufacturer, verifying that the manufacturing facility of a olanzapina active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting olanzapina APIs or olanzapina finished pharmaceutical products to another nation, regulatory agencies frequently require a olanzapina WC (written confirmation) as part of the regulatory process.
click here to find a list of olanzapina 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 olanzapina as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for olanzapina 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 olanzapina 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 olanzapina and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a olanzapina NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of olanzapina suppliers with NDC on PharmaCompass.
olanzapina 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 olanzapina 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 olanzapina GMP manufacturer or olanzapina GMP API supplier for your needs.
A olanzapina CoA (Certificate of Analysis) is a formal document that attests to olanzapina's compliance with olanzapina specifications and serves as a tool for batch-level quality control.
olanzapina CoA mostly includes findings from lab analyses of a specific batch. For each olanzapina 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.
olanzapina may be tested according to a variety of international standards, such as European Pharmacopoeia (olanzapina EP), olanzapina JP (Japanese Pharmacopeia) and the US Pharmacopoeia (olanzapina USP).
