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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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06-Jan-2021
31-Mar-2025
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DOSAGE - TABLET;ORAL - 10MG

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DOSAGE - TABLET;ORAL - 2.5MG

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DOSAGE - TABLET;ORAL - 5MG

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DOSAGE - TABLET;ORAL - 7.5MG

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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 - 5MG

USFDA APPLICATION NUMBER - 21086

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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

Zydis Manufacturers

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

Zydis Suppliers

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

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

Zydis USDMF

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

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

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

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

Zydis KDMF

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

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

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

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

Zydis CEP

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

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

Zydis WC

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

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

Zydis 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 Zydis as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Zydis GMP

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

Zydis CoA

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

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

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