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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 |
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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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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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 40035
Submission : 2025-04-02
Status : Active
Type : II
| 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 : 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 : 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 : 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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Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
3-Thiophene Carboxylic Acid-5-Methyl-2-[2(Nitrophe...
CAS Number : 72242-31-0
End Use API : Olanzapine
About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...
CAS Number : 1493-27-2
End Use API : Olanzapine
About The Company : Anupam Rasayan India Limited was started in 1976 and we are 36 years old. ISO 9001:2008 and ISO 14001:2004 certified chemical company with sound technology, en...
2-Amino-5-Methylthiophene-3-Carbonitrile
CAS Number : 138564-58-6
End Use API : Olanzapine
About The Company : Corey Organics is focused in developing and manufacturing of Active Pharmaceutical Ingredients (APIs), registered Pharma Intermediates, Fine Chemicals and Pyrid...
2-(2-Nitroanilino)-5-methylthiophene-3-carbonitril...
CAS Number : 138564-59-7
End Use API : Olanzapine
About The Company : Corey Organics is focused in developing and manufacturing of Active Pharmaceutical Ingredients (APIs), registered Pharma Intermediates, Fine Chemicals and Pyrid...
4-Amino-2-Methyl10H-Theino-{2,3-b} [1,5]-bdz HCL
CAS Number : 138564-60-0
End Use API : Olanzapine
About The Company : Corey Organics is focused in developing and manufacturing of Active Pharmaceutical Ingredients (APIs), registered Pharma Intermediates, Fine Chemicals and Pyrid...
2-Amino 5-Methylthiophene-3-Carbonitrile
CAS Number : 138564-58-6
End Use API : Olanzapine
About The Company : Maruti Multichem Group, is a leading manufacturer and exporter of a wide range of Reactive Dyestuffs. Maruti Multichem Pvt Ltd is having highly motivated team o...
4-Amino-2-Methyl-10H-Thieno[2,3,b][1,5] Benzdiazep...
CAS Number : 138564-60-0
End Use API : Olanzapine
About The Company : Ramdev Chemicals Pvt. Ltd. is one of the fastest growing Active Pharmaceuticl Drugs, Drug Intermediates, Storage Fine Chemical Company in India which have speci...
2-Amino-5-Methylthiophene-3-Carbonitrile
CAS Number : 138564-58-6
End Use API : Olanzapine
About The Company : We are Rampex Labs, a fully cGMP compliant pharmaceutical intermediates plant located in the outskirts of Hyderabad, India. Our company was founded in 2004 with...
5-Methyl-2-[(2-Nitrophenyl) Amino] Thiophene-3-Car...
CAS Number : 138564-59-7
End Use API : Olanzapine
About The Company : We are Rampex Labs, a fully cGMP compliant pharmaceutical intermediates plant located in the outskirts of Hyderabad, India. Our company was founded in 2004 with...
4-Amino-2-Methyl-10H-Thieno [2, 3-B] [1, 5] Benzod...
CAS Number : 138564-60-0
End Use API : Olanzapine
About The Company : We are Rampex Labs, a fully cGMP compliant pharmaceutical intermediates plant located in the outskirts of Hyderabad, India. Our company was founded in 2004 with...
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Olanzapine Zentiva
Dosage Form : Tablet
Dosage Strength : 2.5mg
Packaging :
Approval Date : 07/12/2010
Application Number : 61514
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Olanzapine Zentiva
Dosage Form : Tablet
Dosage Strength : 5mg
Packaging :
Approval Date : 07/12/2010
Application Number : 61514
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Olanzapine Zentiva
Dosage Form : Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 07/12/2010
Application Number : 61514
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Olanzapine Zentiva
Dosage Form : Tablet
Dosage Strength : 15mg
Packaging :
Approval Date : 07/12/2010
Application Number : 61514
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Olanzapine Zentiva
Dosage Form : Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 07/12/2010
Application Number : 61514
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Olanzapin Aspen
Dosage Form : Orodispersible Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 27/09/2012
Application Number : 20120331000105
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Olanzapin Aspen
Dosage Form : Orodispersible Tablet
Dosage Strength : 15mg
Packaging :
Approval Date : 27/09/2012
Application Number : 20120331000112
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Olanzapin Aspen
Dosage Form : Orodispersible Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 27/09/2012
Application Number : 20120331000129
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Olanzapin Aspen
Dosage Form : Orodispersible Tablet
Dosage Strength : 5mg
Packaging :
Approval Date : 27/09/2012
Application Number : 20120331000068
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Olanzapine Orion
Dosage Form : Film Coated Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 20/11/2009
Application Number : 20090407000134
Regulatory Info : Deregistered
Registration Country : Sweden
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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Patents & EXCLUSIVITIES
US Patents
Patent Expiration Date : 2031-08-23
OLANZAPINE; SAMIDORPHAN L-MALATE
US Patent Number : 9517235
Drug Substance Claim :
Drug Product Claim :
Application Number : 213378
Patent Use Code : U-3138
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-08-23
Patent Expiration Date : 2031-08-23
OLANZAPINE; SAMIDORPHAN L-MALATE
US Patent Number : 12194035
Drug Substance Claim :
Drug Product Claim :
Application Number : 213378
Patent Use Code : U-3141
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-08-23
Patent Expiration Date : 2031-08-30
OLANZAPINE; SAMIDORPHAN L-MALATE
US Patent Number : 9119848
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 213378
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-08-30
Patent Expiration Date : 2031-08-23
OLANZAPINE; SAMIDORPHAN L-MALATE
US Patent Number : 9517235
Drug Substance Claim :
Drug Product Claim :
Application Number : 213378
Patent Use Code : U-3139
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-08-23
Patent Expiration Date : 2025-11-23
OLANZAPINE; SAMIDORPHAN L-MALATE
US Patent Number : 7262298
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 213378
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-11-23
Patent Expiration Date : 2041-11-12
OLANZAPINE; SAMIDORPHAN L-MALATE
US Patent Number : 11951111
Drug Substance Claim :
Drug Product Claim :
Application Number : 213378
Patent Use Code : U-3887
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2041-11-12
Patent Expiration Date : 2032-02-13
OLANZAPINE; SAMIDORPHAN L-MALATE
US Patent Number : 8778960
Drug Substance Claim :
Drug Product Claim :
Application Number : 213378
Patent Use Code : U-3137
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2032-02-13
Patent Expiration Date : 2031-08-23
OLANZAPINE; SAMIDORPHAN L-MALATE
US Patent Number : 10716785
Drug Substance Claim :
Drug Product Claim :
Application Number : 213378
Patent Use Code : U-3136
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-08-23
Patent Expiration Date : 2031-08-23
OLANZAPINE; SAMIDORPHAN L-MALATE
US Patent Number : 11351166
Drug Substance Claim :
Drug Product Claim :
Application Number : 213378
Patent Use Code : U-3141
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-08-23
Patent Expiration Date : 2031-08-23
OLANZAPINE; SAMIDORPHAN L-MALATE
US Patent Number : 10300054
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 213378
Patent Use Code : U-3140
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-08-23
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
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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 Olanzapine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Olanzapine, including repackagers and relabelers. The FDA regulates Olanzapine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Olanzapine 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 Olanzapine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Olanzapine supplier is an individual or a company that provides Olanzapine active pharmaceutical ingredient (API) or Olanzapine finished formulations upon request. The Olanzapine suppliers may include Olanzapine API manufacturers, exporters, distributors and traders.
click here to find a list of Olanzapine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Olanzapine DMF (Drug Master File) is a document detailing the whole manufacturing process of Olanzapine active pharmaceutical ingredient (API) in detail. Different forms of Olanzapine DMFs exist exist since differing nations have different regulations, such as Olanzapine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Olanzapine DMF submitted to regulatory agencies in the US is known as a USDMF. Olanzapine USDMF includes data on Olanzapine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Olanzapine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Olanzapine 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 Olanzapine Drug Master File in Japan (Olanzapine JDMF) empowers Olanzapine 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 Olanzapine JDMF during the approval evaluation for pharmaceutical products. At the time of Olanzapine 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 Olanzapine 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 Olanzapine Drug Master File in Korea (Olanzapine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Olanzapine. The MFDS reviews the Olanzapine KDMF as part of the drug registration process and uses the information provided in the Olanzapine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Olanzapine 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 Olanzapine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Olanzapine suppliers with KDMF on PharmaCompass.
A Olanzapine CEP of the European Pharmacopoeia monograph is often referred to as a Olanzapine Certificate of Suitability (COS). The purpose of a Olanzapine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Olanzapine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Olanzapine to their clients by showing that a Olanzapine CEP has been issued for it. The manufacturer submits a Olanzapine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Olanzapine CEP holder for the record. Additionally, the data presented in the Olanzapine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Olanzapine DMF.
A Olanzapine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Olanzapine 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 Olanzapine suppliers with CEP (COS) on PharmaCompass.
A Olanzapine written confirmation (Olanzapine WC) is an official document issued by a regulatory agency to a Olanzapine manufacturer, verifying that the manufacturing facility of a Olanzapine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Olanzapine APIs or Olanzapine finished pharmaceutical products to another nation, regulatory agencies frequently require a Olanzapine WC (written confirmation) as part of the regulatory process.
click here to find a list of Olanzapine 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 Olanzapine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Olanzapine 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 Olanzapine 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 Olanzapine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Olanzapine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Olanzapine suppliers with NDC on PharmaCompass.
Olanzapine 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 Olanzapine 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 Olanzapine GMP manufacturer or Olanzapine GMP API supplier for your needs.
A Olanzapine CoA (Certificate of Analysis) is a formal document that attests to Olanzapine's compliance with Olanzapine specifications and serves as a tool for batch-level quality control.
Olanzapine CoA mostly includes findings from lab analyses of a specific batch. For each Olanzapine 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.
Olanzapine may be tested according to a variety of international standards, such as European Pharmacopoeia (Olanzapine EP), Olanzapine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Olanzapine USP).
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