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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

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D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"UNITED STATES PHARMACOPEIAL ","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.000015","unit":"KGS","unitRateFc":"162800000","totalValueFC":"2875.6","currency":"USD","unitRateINR":"15253652667","date":"27-Aug-2022","totalValueINR":"228804.79","totalValueInUsd":"2875.6","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"2190162","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1661538600,"product":"OLANZAPINE RELATED COMPOUND C (QTY: 5 X 0.05 GMS, PRICE: USD19.87\/EACH)(FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"UNITED STATES PHARMACOPEIAL ","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00025","unit":"KGS","unitRateFc":"397400","totalValueFC":"117","currency":"USD","unitRateINR":"37234640","date":"27-Aug-2022","totalValueINR":"9308.66","totalValueInUsd":"117","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"2190162","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1676399400,"product":"OLANZAPINE (TEST LIC NO TL\/AZ\/20\/001742) FOR R & D PURPOSE NOT FOR SALE","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"7500","totalValueFC":"416.8","currency":"EUR","unitRateINR":"688500","date":"15-Feb-2023","totalValueINR":"34425","totalValueInUsd":"416.8","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"4654025","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677522600,"product":"OLANZAPINE USP (TL NO: TL\/AZ\/22\/000230) FOR R & D PURPOSE NOT FOR SALE","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"INKE S.A","supplierCountry":"SPAIN","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"0.45","actualQuantity":"0.45","unit":"KGS","unitRateFc":"7500","totalValueFC":"3688","currency":"EUR","unitRateINR":"676875","date":"28-Feb-2023","totalValueINR":"304593.75","totalValueInUsd":"3688","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"4839180","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688495400,"product":"OLANZAPINE PH.EUR RE-IMPORT GOODS VIDE SB NO-7147897\/30-12-2021 & EXP INV-SI3621122894\/25.12.2021","address":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con","city":"HYDERABAD","supplier":"GEDEON RICHTER","supplierCountry":"INDIA","foreign_port":"NA","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"1800","totalValueFC":"37777.8","currency":"USD","unitRateINR":"155247","date":"05-Jul-2023","totalValueINR":"3104936.695","totalValueInUsd":"37777.8","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691778600,"product":"OLANZAPINE FORM I","address":"SYNO.257 & 258\/1, DNO.11-6\/56,,C-B LOCK OPP IDPL FACTORY MOOSAPET VILLAGE BALANGAR POST","city":"HYDERABAD","supplier":"CHEMICAL-SOLUTION INC","supplierCountry":"INDIA","foreign_port":"NA","customer":"LEE PHARMA","customerCountry":"INDIA","quantity":"9.91","actualQuantity":"9.91","unit":"KGS","unitRateFc":"1700","totalValueFC":"17422.6","currency":"USD","unitRateINR":"144176.7","date":"12-Aug-2023","totalValueINR":"1443223.584","totalValueInUsd":"17422.6","indian_port":"CHENNAI AIR","hs_no":"29349990","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SYNO.257 & 258\/1, DNO.11-6\/56,,C-B LOCK OPP IDPL FACTORY MOOSAPET VILLAGE BALANGAR POST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699900200,"product":"2-METHYL-4-(4-METHYL-1-PIPERAZINYL)-10H-THIENO(2,3-B)(1,5)BENZODIAZEPINE-OLANZAPINE (INTERMEDIATES FOR PHARMA)","address":"320\/E, 9A MAIN, 5TH BLOCK","city":"BANGALORE","supplier":"APOTEX INC","supplierCountry":"CANADA","foreign_port":"MONTREAL-DORAVAL APT","customer":"APOTEX INC","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"4","unit":"GMS","unitRateFc":"203","totalValueFC":"820.6","currency":"USD","unitRateINR":"17082.5","date":"14-Nov-2023","totalValueINR":"68329.8","totalValueInUsd":"820.6","indian_port":"Bangalore Air","hs_no":"29349990","bill_no":"8756856","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"MONTREAL-DORAVAL APT","supplierAddress":"34 SPALDING DRIVEBRANTFORD ONCANADA N3T 6B8 CANADA","customerAddress":"320\/E, 9A MAIN, 5TH BLOCK"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1700850600,"product":"OLANZAPINE FORM I(SB.NO.6549755 DATE:29.12.2022)","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"JOSWE MEDICAL","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"LEE PHARMA","customerCountry":"INDIA","quantity":"49.50","actualQuantity":"49.5","unit":"KGS","unitRateFc":"1200","totalValueFC":"61747","currency":"USD","unitRateINR":"103873.3","date":"25-Nov-2023","totalValueINR":"5141726.83","totalValueInUsd":"61747","indian_port":"Madras Air","hs_no":"29349990","bill_no":"8942368","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"DUBAI","supplierAddress":"JORDAN-SWEDEN MEDICAL& STERILIZATION CO. P.O.BOX.851831AMMAN JO","customerAddress":"SYNO.257 258\/1, DNO.11-6\/56,"}]
05-Jan-2021
31-Mar-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 10MG

USFDA APPLICATION NUMBER - 20592

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DOSAGE - TABLET;ORAL - 15MG

USFDA APPLICATION NUMBER - 20592

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DOSAGE - TABLET;ORAL - 2.5MG

USFDA APPLICATION NUMBER - 20592

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DOSAGE - TABLET;ORAL - 20MG

USFDA APPLICATION NUMBER - 20592

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DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 20592

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DOSAGE - TABLET;ORAL - 7.5MG

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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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 15MG

USFDA APPLICATION NUMBER - 21086

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DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL -...DOSAGE - TABLET, ORALLY DISINTEGRATING;ORAL - 20MG

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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ABOUT THIS PAGE

Looking for / Olanzapine API manufacturers, exporters & distributors?

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

2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine Manufacturers

A 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine, including repackagers and relabelers. The FDA regulates 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine 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 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine Suppliers

A 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine supplier is an individual or a company that provides 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine active pharmaceutical ingredient (API) or 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine finished formulations upon request. The 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine suppliers may include 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine API manufacturers, exporters, distributors and traders.

click here to find a list of 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine USDMF

A 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine DMF (Drug Master File) is a document detailing the whole manufacturing process of 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine active pharmaceutical ingredient (API) in detail. Different forms of 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine DMFs exist exist since differing nations have different regulations, such as 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine DMF submitted to regulatory agencies in the US is known as a USDMF. 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine USDMF includes data on 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine suppliers with USDMF on PharmaCompass.

2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine 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 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine Drug Master File in Japan (2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine JDMF) empowers 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine 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 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine JDMF during the approval evaluation for pharmaceutical products. At the time of 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine 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 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine suppliers with JDMF on PharmaCompass.

2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine KDMF

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

Pharmaceutical companies submit a 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine Drug Master File in Korea (2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine. The MFDS reviews the 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine KDMF as part of the drug registration process and uses the information provided in the 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine KDMF to evaluate the safety and efficacy of the drug.

After submitting a 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine 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 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine suppliers with KDMF on PharmaCompass.

2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine CEP

A 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine CEP of the European Pharmacopoeia monograph is often referred to as a 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine Certificate of Suitability (COS). The purpose of a 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine to their clients by showing that a 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine CEP has been issued for it. The manufacturer submits a 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine CEP (COS) as part of the market authorization procedure, and it takes on the role of a 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine CEP holder for the record. Additionally, the data presented in the 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine DMF.

A 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine 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 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine suppliers with CEP (COS) on PharmaCompass.

2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine WC

A 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine written confirmation (2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine WC) is an official document issued by a regulatory agency to a 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine manufacturer, verifying that the manufacturing facility of a 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine APIs or 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine finished pharmaceutical products to another nation, regulatory agencies frequently require a 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine WC (written confirmation) as part of the regulatory process.

click here to find a list of 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine suppliers with Written Confirmation (WC) on PharmaCompass.

2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine 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 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine 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 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine 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 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine suppliers with NDC on PharmaCompass.

2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine GMP

2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine 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 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine 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 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine GMP manufacturer or 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine GMP API supplier for your needs.

2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine CoA

A 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine CoA (Certificate of Analysis) is a formal document that attests to 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine's compliance with 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine specifications and serves as a tool for batch-level quality control.

2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine CoA mostly includes findings from lab analyses of a specific batch. For each 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine 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.

2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine may be tested according to a variety of international standards, such as European Pharmacopoeia (2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine EP), 2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (2-methyl-4-(4-methylpiperazin-1-yl)-5H-thieno[2,3-b][1,5]benzodiazepine 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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