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VMF
DRUG PRODUCT COMPOSITIONS0
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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
Nortec Quimica is the largest API manufacturer in Latin America.
Inke S.A: APIs manufacturing plant.
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 : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samo Pharmaceutical Co., Ltd.
Registration Date : 2020-11-13
Registration Number : 20201113-209-J-568
Manufacturer Name : INKE S.A.
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.
Jai Radhe Sales is your partner for all your sourcing needs.
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Neuland Laboratories- A dedicated 100% API provider.
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 : Sy. No. 347,473,474, 490/2 Bonthapally village, Veerabhadraswamy Temple Road, Jinnaram Mandal, Medak Dist. Telangana State India
NDC Package Code : 58032-0122
Start Marketing Date : 2017-12-14
End Marketing Date : 2024-12-31
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
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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 : A1/B, SIPCOT Industrial Complex, Kudikadu, Cuddalore-607 005
NDC Package Code : 72643-023
Start Marketing Date : 2020-05-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Inseong Trading Co., Ltd.
Registration Date : 2021-07-21
Registration Number : 20210721-209-J-1041
Manufacturer Name : Solara Active Pharma Sciences Limited
Manufacturer Address : A1/B, SIPCOT Industrial Complex, Kudikadu, Cuddalore- 607 005, India
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 : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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USDMF
Inke S.A: APIs manufacturing plant.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-03
Pay. Date : 2013-01-23
DMF Number : 26694
Submission : 2013-01-24
Status : Active
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19282
Submission : 2006-03-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15052
Submission : 2000-09-18
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-12-10
DMF Number : 20591
Submission : 2007-06-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-12-17
DMF Number : 20990
Submission : 2007-10-22
Status : Active
Type : II
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Rev. Date :
Pay. Date :
DMF Number : 20354
Submission : 2007-03-16
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-13
Pay. Date : 2021-07-09
DMF Number : 18260
Submission : 2005-04-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-18
Pay. Date : 2014-02-10
DMF Number : 20218
Submission : 2007-01-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18108
Submission : 2005-02-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18867
Submission : 2005-10-14
Status : Inactive
Type : II
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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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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Olanzapin Zentiva
Dosage Form : Tablet
Dosage Strength : 10mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Olanzapin Zentiva
Dosage Form : Tablet
Dosage Strength : 15mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Olanzapine Zentiva
Dosage Form : Tabl
Dosage Strength : 2.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Olanzapine Zentiva
Dosage Form : Tabl
Dosage Strength : 5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : OLAWIN FILM COATED 2,5 MG
Dosage Form : FCT
Dosage Strength : 20mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Prexolan ODT 5
Dosage Form : TAB
Dosage Strength : 5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Prexolan ODT 10
Dosage Form : TAB
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Prexolan 2,5
Dosage Form : TAB
Dosage Strength : 2.5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Prexolan 5
Dosage Form : FCT
Dosage Strength : 5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Prexolan 10
Dosage Form : FCT
Dosage Strength : 10mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code : AB
Brand Name : OLANZAPINE
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 5MG
Approval Date : 2011-10-24
Application Number : 78109
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code : AB
Brand Name : OLANZAPINE
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 10MG
Approval Date : 2011-10-24
Application Number : 78109
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code : AB
Brand Name : OLANZAPINE
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 15MG
Approval Date : 2011-10-24
Application Number : 78109
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code : AB
Brand Name : OLANZAPINE
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 20MG
Approval Date : 2011-10-24
Application Number : 78109
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code :
OLANZAPINE; SAMIDORPHAN L-MALATE
Brand Name : LYBALVI
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG;EQ 10MG BASE
Approval Date : 2021-05-28
Application Number : 213378
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code : AB
Brand Name : OLANZAPINE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Approval Date : 2012-04-23
Application Number : 90798
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : OLANZAPINE
Dosage Form : TABLET;ORAL
Dosage Strength : 7.5MG
Approval Date : 2016-03-15
Application Number : 203333
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code : AB
Brand Name : ZYPREXA
Dosage Form : TABLET;ORAL
Dosage Strength : 2.5MG
Approval Date : 1996-09-30
Application Number : 20592
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : No
TE Code : AB
Brand Name : OLANZAPINE
Dosage Form : TABLET;ORAL
Dosage Strength : 2.5MG
Approval Date : 2012-04-23
Application Number : 202287
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
Brand Name : OLANZAPINE
Dosage Form : TABLET, ORALLY DISINTEGRATING;ORAL
Dosage Strength : 15MG
Approval Date : 2020-12-31
Application Number : 206892
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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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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