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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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Registration Number : 227MF10030
Registrant's Address : 2477, Nambusunhwan-ro Seocho-gu, Seoul, Republic of Korea
Initial Date of Registration : 2015-01-23
Latest Date of Registration : 2015-11-11
Registration Number : 227MF10066
Registrant's Address : 1062-8 Honjo, Nishikata-cho, Tochigi City, Tochigi Prefecture
Initial Date of Registration : 2015-03-06
Latest Date of Registration : 2015-11-11
Registration Number : 227MF10033
Registrant's Address : No. 9 Dongjin Road, Economic & Technical Development Zone, Lianyungang, Jiangsu 22206...
Initial Date of Registration : 2015-01-23
Latest Date of Registration : 2015-01-23
Registration Number : 227MF10065
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...
Initial Date of Registration : 2015-03-06
Latest Date of Registration : 2015-11-19
Registration Number : 227MF10037
Registrant's Address : 1A, Sector 16A, Noida 201 301, Uttar Pradesh, India
Initial Date of Registration : 2015-02-04
Latest Date of Registration : 2015-02-04
Registration Number : 227MF10016
Registrant's Address : 1-10-11 Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2015-01-05
Latest Date of Registration : 2015-11-17
Registration Number : 227MF10025
Registrant's Address : 2-36-1 Kanda Jinbocho, Chiyoda-ku, Tokyo
Initial Date of Registration : 2015-01-23
Latest Date of Registration : 2015-11-17
Olanzapine (for manufacturing only)
Registration Number : 226MF10142
Registrant's Address : 2-3-5 Shimookui, Toyama City, Toyama Prefecture
Initial Date of Registration : 2014-07-31
Latest Date of Registration : 2015-05-14
Registration Number : 227MF10046
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2015-02-09
Latest Date of Registration : 2015-11-11
Registration Number : 226MF10039
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2014-02-19
Latest Date of Registration : 2015-11-17
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| Importing Country | Total Quantity (KGS) |
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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ABOUT THIS PAGE
68
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 Lanzep manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lanzep, including repackagers and relabelers. The FDA regulates Lanzep manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lanzep 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 Lanzep manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lanzep supplier is an individual or a company that provides Lanzep active pharmaceutical ingredient (API) or Lanzep finished formulations upon request. The Lanzep suppliers may include Lanzep API manufacturers, exporters, distributors and traders.
click here to find a list of Lanzep suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lanzep DMF (Drug Master File) is a document detailing the whole manufacturing process of Lanzep active pharmaceutical ingredient (API) in detail. Different forms of Lanzep DMFs exist exist since differing nations have different regulations, such as Lanzep USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lanzep DMF submitted to regulatory agencies in the US is known as a USDMF. Lanzep USDMF includes data on Lanzep's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lanzep USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lanzep 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 Lanzep Drug Master File in Japan (Lanzep JDMF) empowers Lanzep 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 Lanzep JDMF during the approval evaluation for pharmaceutical products. At the time of Lanzep 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 Lanzep 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 Lanzep Drug Master File in Korea (Lanzep KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lanzep. The MFDS reviews the Lanzep KDMF as part of the drug registration process and uses the information provided in the Lanzep KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lanzep 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 Lanzep API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lanzep suppliers with KDMF on PharmaCompass.
A Lanzep CEP of the European Pharmacopoeia monograph is often referred to as a Lanzep Certificate of Suitability (COS). The purpose of a Lanzep CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lanzep EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lanzep to their clients by showing that a Lanzep CEP has been issued for it. The manufacturer submits a Lanzep CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lanzep CEP holder for the record. Additionally, the data presented in the Lanzep CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lanzep DMF.
A Lanzep CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lanzep 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 Lanzep suppliers with CEP (COS) on PharmaCompass.
A Lanzep written confirmation (Lanzep WC) is an official document issued by a regulatory agency to a Lanzep manufacturer, verifying that the manufacturing facility of a Lanzep active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lanzep APIs or Lanzep finished pharmaceutical products to another nation, regulatory agencies frequently require a Lanzep WC (written confirmation) as part of the regulatory process.
click here to find a list of Lanzep 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 Lanzep as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lanzep 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 Lanzep 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 Lanzep and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lanzep NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lanzep suppliers with NDC on PharmaCompass.
Lanzep 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 Lanzep 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 Lanzep GMP manufacturer or Lanzep GMP API supplier for your needs.
A Lanzep CoA (Certificate of Analysis) is a formal document that attests to Lanzep's compliance with Lanzep specifications and serves as a tool for batch-level quality control.
Lanzep CoA mostly includes findings from lab analyses of a specific batch. For each Lanzep 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.
Lanzep may be tested according to a variety of international standards, such as European Pharmacopoeia (Lanzep EP), Lanzep JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lanzep USP).
