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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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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.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19282
Submission : 2006-03-24
Status : Active
Type : II
Certificate Number : R1-CEP 2012-190 - Rev 01
Issue Date : 2021-09-07
Type : Chemical
Substance Number : 2258
Status : Valid
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-0122
Start Marketing Date : 2017-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samil Pharmaceutical Co., Ltd.
Registration Date : 2022-08-22
Registration Number : 20220822-209-J-1347
Manufacturer Name : Neuland Laboratories Ltd
Manufacturer Address : Unit-I, Survey No: 347, 473, 474, 490/2 Veerabhadraswamy temple road,Bonthapally Village, Gummadidala Mandal,Sangareddy District - 502313, Telangana, India
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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 : 2019-06-17
Valid Till : 2022-05-26
Written Confirmation Number : WC-0002
Address of the Firm :
NDC Package Code : 15894-0006
Start Marketing Date : 2019-07-15
End Marketing Date : 2025-12-31
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 |
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-13
Pay. Date : 2021-07-09
DMF Number : 18260
Submission : 2005-04-08
Status : Active
Type : II
Certificate Number : R1-CEP 2012-050 - Rev 02
Issue Date : 2023-02-21
Type : Chemical
Substance Number : 2258
Status : Valid
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm :
NDC Package Code : 72643-023
Start Marketing Date : 2020-05-25
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmasolution Co., Ltd.
Registration Date : 2024-08-26
Registration Number : 20210721-209-J-1041(1)
Manufacturer Name : Solara Active Pharma Sciences Limited
Manufacturer Address : A1/B, SIPCOT Industrial Complex, Kudikadu, Cuddalore- 607 005, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28976
Submission : 2015-01-08
Status : Inactive
Type : II
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Average Price (USD/KGS) |
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USFDA APPLICATION NUMBER - 20592
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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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USFDA APPLICATION NUMBER - 21086
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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 Zypadhera manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zypadhera, including repackagers and relabelers. The FDA regulates Zypadhera manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zypadhera 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 Zypadhera manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zypadhera supplier is an individual or a company that provides Zypadhera active pharmaceutical ingredient (API) or Zypadhera finished formulations upon request. The Zypadhera suppliers may include Zypadhera API manufacturers, exporters, distributors and traders.
click here to find a list of Zypadhera suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zypadhera DMF (Drug Master File) is a document detailing the whole manufacturing process of Zypadhera active pharmaceutical ingredient (API) in detail. Different forms of Zypadhera DMFs exist exist since differing nations have different regulations, such as Zypadhera USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zypadhera DMF submitted to regulatory agencies in the US is known as a USDMF. Zypadhera USDMF includes data on Zypadhera's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zypadhera USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zypadhera 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 Zypadhera Drug Master File in Japan (Zypadhera JDMF) empowers Zypadhera 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 Zypadhera JDMF during the approval evaluation for pharmaceutical products. At the time of Zypadhera 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 Zypadhera 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 Zypadhera Drug Master File in Korea (Zypadhera KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zypadhera. The MFDS reviews the Zypadhera KDMF as part of the drug registration process and uses the information provided in the Zypadhera KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zypadhera 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 Zypadhera API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zypadhera suppliers with KDMF on PharmaCompass.
A Zypadhera CEP of the European Pharmacopoeia monograph is often referred to as a Zypadhera Certificate of Suitability (COS). The purpose of a Zypadhera CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Zypadhera EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Zypadhera to their clients by showing that a Zypadhera CEP has been issued for it. The manufacturer submits a Zypadhera CEP (COS) as part of the market authorization procedure, and it takes on the role of a Zypadhera CEP holder for the record. Additionally, the data presented in the Zypadhera CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Zypadhera DMF.
A Zypadhera CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zypadhera 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 Zypadhera suppliers with CEP (COS) on PharmaCompass.
A Zypadhera written confirmation (Zypadhera WC) is an official document issued by a regulatory agency to a Zypadhera manufacturer, verifying that the manufacturing facility of a Zypadhera active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Zypadhera APIs or Zypadhera finished pharmaceutical products to another nation, regulatory agencies frequently require a Zypadhera WC (written confirmation) as part of the regulatory process.
click here to find a list of Zypadhera 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 Zypadhera as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Zypadhera 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 Zypadhera 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 Zypadhera and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zypadhera NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Zypadhera suppliers with NDC on PharmaCompass.
Zypadhera 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 Zypadhera 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 Zypadhera GMP manufacturer or Zypadhera GMP API supplier for your needs.
A Zypadhera CoA (Certificate of Analysis) is a formal document that attests to Zypadhera's compliance with Zypadhera specifications and serves as a tool for batch-level quality control.
Zypadhera CoA mostly includes findings from lab analyses of a specific batch. For each Zypadhera 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.
Zypadhera may be tested according to a variety of international standards, such as European Pharmacopoeia (Zypadhera EP), Zypadhera JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zypadhera USP).
