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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
Inke S.A: APIs manufacturing plant.
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DMF Review : Reviewed
Rev. Date : 2014-03-03
Pay. Date : 2013-01-23
DMF Number : 26694
Submission : 2013-01-24
Status : Active
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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
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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.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Neuland Laboratories- A dedicated 100% API provider.
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Submission : 2006-03-24
Status : Active
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NDC Package Code : 58032-0122
Start Marketing Date : 2017-12-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samil Pharmaceutical Co., Ltd.
Registration Date : 2022-08-22
Registration Number : 20220822-209-J-1347
Manufacturer Name : Neuland Laboratories Ltd
Manufacturer Address : Unit-I, Survey No: 347, 473, 474, 490/2 Veerabhadraswamy temple road,Bonthapally Village, Gummadidala Mandal,Sangareddy District - 502313, Telangana, India
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.
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Date of Issue : 2025-04-24
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Written Confirmation Number : WC-0002
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NDC Package Code : 15894-0006
Start Marketing Date : 2019-07-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
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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
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Substance Number : 2258
Status : Valid
Date of Issue : 2022-06-15
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DMF Number : 26763
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Substance Number : 2258
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NDC Package Code : 49587-103
Start Marketing Date : 2014-12-22
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Dosage Form (Strength) : POWDER (1kg/kg)
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Inke S.A: APIs manufacturing plant.
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Neuland Laboratories- A dedicated 100% API provider.
GDUFA
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Submission : 2006-03-24
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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
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DMF Number : 20218
Submission : 2007-01-29
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Submission : 2000-09-18
Status : Inactive
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Submission : 2007-06-11
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Certificate Number : R0-CEP 2015-058 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2016-06-17
Type : Chemical
Substance Number : 2258
Olanzapine, Form-I, Process II
Certificate Number : R0-CEP 2022-126 - Rev 00
Status : Valid
Issue Date : 2022-06-22
Type : Chemical
Substance Number : 2258
Certificate Number : R1-CEP 2012-215 - Rev 00
Status : Valid
Issue Date : 2019-01-29
Type : Chemical
Substance Number : 2258
Certificate Number : R0-CEP 2018-111 - Rev 00
Status : Valid
Issue Date : 2020-06-10
Type : Chemical
Substance Number : 2258
Certificate Number : R0-CEP 2012-402 - Rev 00
Status : Expired
Issue Date : 2015-01-23
Type : Chemical
Substance Number : 2258
Certificate Number : R1-CEP 2014-003 - Rev 00
Status : Valid
Issue Date : 2020-02-21
Type : Chemical
Substance Number : 2258
Certificate Number : R0-CEP 2012-208 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2014-07-15
Type : Chemical
Substance Number : 2258
Certificate Number : R1-CEP 2015-238 - Rev 00
Status : Valid
Issue Date : 2022-03-03
Type : Chemical
Substance Number : 2258
Certificate Number : R1-CEP 2012-300 - Rev 01
Status : Valid
Issue Date : 2021-02-09
Type : Chemical
Substance Number : 2258
Certificate Number : R0-CEP 2019-182 - Rev 01
Status : Valid
Issue Date : 2022-09-12
Type : Chemical
Substance Number : 2258
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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 : 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
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Initial Date of Registration : 2015-01-05
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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 purposes only)
Registration Number : 226MF10142
Registrant's Address : 326 Yokamachi, 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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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Date of Issue : 2025-04-24
Valid Till : 2028-05-25
Written Confirmation Number : WC-0002
Address of the Firm : Plot No. A-2, A-2/1, A-/2, UPSIDC Industrial Area, Bijnor Road, Gajraula -244235...
Date of Issue : 2022-06-06
Valid Till : 2025-06-10
Written Confirmation Number : WC-0017
Address of the Firm : Unit-II, SurveyNo.:10&13,Gaddapotharam (Village), IDA-Kazipally, Jinnaram (Manda...
Date of Issue : 2022-09-01
Valid Till : 2025-07-02
Written Confirmation Number : WC-0074Amended
Address of the Firm : 294, GIDC Estate Ankleshwar, Bharuch-393002, Gujarat India
Date of Issue : 2022-04-07
Valid Till : 2025-03-07
Written Confirmation Number : WC-0040n
Address of the Firm : Sy. No. 213, 214 & 255, Bonthapally Village, Gummadidala Mandai, Sangareddy Dist...
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Written Confirmation Number : WC-0091n
Address of the Firm : P.O. Sejavta, Dist. Ratlam, Madhya Pradesh, India.
Date of Issue : 2023-02-13
Valid Till : 2025-07-02
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Address of the Firm : No.21M, Attibele Industrial Area, Anekal Taluk, Bangalore-562107, Karnataka, Ind...
Date of Issue : 2023-09-14
Valid Till : 2025-05-06
Written Confirmation Number : WC-0026
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Written Confirmation Number : WC-0026
Address of the Firm : Plot No. 9/A, Phase-lll, Jeedimetla Village, Quthbullapur Mandal, Medchal-Malkaj...
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Valid Till : 2025-07-02
Written Confirmation Number : WC-0079
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Address of the Firm : Sy. No. 14, Gaddapotharam Village, IDA, Kazipally, Jinnaram Mandal, Sangareddy D...
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Inke S.A: APIs manufacturing plant.
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
Neuland Laboratories- A dedicated 100% API provider.
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 Vill...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2020-06-11
Registration Number : 20200611-209-J-402
Manufacturer Name : Teva API India Private Limit...
Manufacturer Address : Plot No, A-2, A-2/1, A-2/2, UPSIDC Industrial Area, Gajraula, Distt. Amroha(UP) India
Registrant Name : Korea Lily (U.S.)
Registration Date : 2025-03-14
Registration Number : 20250314-209-J-1802
Manufacturer Name : Cambrex, Karlskoga AB
Manufacturer Address : Björkborns Industriområde Karlskoga, 691 85, Sweden
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-01-10
Registration Number : 20220110-209-J-1201
Manufacturer Name : Jubilant Generics Limited
Manufacturer Address : Plot No. 18, 56, 57 & 58, KIADB Industrial Area, Nanjangud-571 302, Mysore District, ...
Registrant Name : Youngjin Pharmaceutical Co., Ltd.
Registration Date : 2025-05-09
Registration Number : 20210409-209-J-926(1)
Manufacturer Name : Nosch Labs Private Limited U...
Manufacturer Address : Sy.No.14, Gaddapotharam Village, IDA, Kazipally, Jinnaram Mandal, Sangareddy District...
Registrant Name : Pharmasolution Co., Ltd.
Registration Date : 2024-08-26
Registration Number : 20210721-209-J-1041(1)
Manufacturer Name : Solara Active Pharma Science...
Manufacturer Address : A1/B, SIPCOT Industrial Complex, Kudikadu, Cuddalore- 607 005, India
Registrant Name : Insung Trading Co., Ltd.
Registration Date : 2021-07-21
Registration Number : 20210721-209-J-1041
Manufacturer Name : Solara Active Pharma Science...
Manufacturer Address : A1/B, SIPCOT Industrial Complex, Kudikadu, Cuddalore- 607 005, India
Registrant Name : Samil Pharmaceutical Co., Ltd.
Registration Date : 2023-05-19
Registration Number : 20230519-209-J-1493
Manufacturer Name : Zhejiang Supor Pharmaceutica...
Manufacturer Address : Yuedong Road, Paojiang Industrial Zone, Shaoxing, Zhejiang 312071, PRChina
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Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of expertise in formulation development, manufacturing, and commercialization. Our portfolio...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
About the Company : Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission i...
About the Company : Founded in 1997, Lee Pharma Limited has transformed from a small venture into a global leader in the pharmaceutical industry. Our journey began with a commitment to providing affor...
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 specialty in Synthesis Mo...
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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 :
Registration Country : Sweden
Brand Name : Olanzapine Orion
Dosage Form : ORODISPERSIBLE TABLET
Dosage Strength : 20 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Olanzapine Orion
Dosage Form : TABLET
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Olanzapine Orion
Dosage Form : TABLET
Dosage Strength : 20 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Olanzapine Orion
Dosage Form : TABLET
Dosage Strength : 10 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Olanzapine Orion
Dosage Form : TABLET
Dosage Strength : 7.5 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Olanzapine Orion
Dosage Form : ORODISPERSIBLE TABLET
Dosage Strength : 5 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Olanzapine
Dosage Form : DC Granules
Dosage Strength : 2.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : DC Granules
Dosage Strength : 2.5MG
Brand Name : Olanzapine
Approval Date :
Application Number :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Olanzapine
Dosage Form : DC Granules
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : DC Granules
Dosage Strength : 5MG
Brand Name : Olanzapine
Approval Date :
Application Number :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Olanzapine
Dosage Form : DC Granules
Dosage Strength : 7.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : DC Granules
Dosage Strength : 7.5MG
Brand Name : Olanzapine
Approval Date :
Application Number :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Olanzapine
Dosage Form : DC Granules
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : DC Granules
Dosage Strength : 10MG
Brand Name : Olanzapine
Approval Date :
Application Number :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Olanzapine
Dosage Form : DC Granules
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Packaging :
Regulatory Info :
Dosage : DC Granules
Dosage Strength : 20MG
Brand Name : Olanzapine
Approval Date :
Application Number :
Registration Country : India
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 2.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : EU Approved
Dosage : Film Coated Tablet
Dosage Strength : 2.5MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : EU Approved
Dosage : Film Coated Tablet
Dosage Strength : 5MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : EU Approved
Dosage : Film Coated Tablet
Dosage Strength : 10MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : EU Approved
Dosage : Film Coated Tablet
Dosage Strength : 20MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Orodispersible Tablet
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : EU Approved
Dosage : Orodispersible Tablet
Dosage Strength : 15MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
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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ABOUT THIS PAGE
96
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 ZYPREXA RELPREVV manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ZYPREXA RELPREVV, including repackagers and relabelers. The FDA regulates ZYPREXA RELPREVV manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ZYPREXA RELPREVV 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 ZYPREXA RELPREVV manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ZYPREXA RELPREVV supplier is an individual or a company that provides ZYPREXA RELPREVV active pharmaceutical ingredient (API) or ZYPREXA RELPREVV finished formulations upon request. The ZYPREXA RELPREVV suppliers may include ZYPREXA RELPREVV API manufacturers, exporters, distributors and traders.
click here to find a list of ZYPREXA RELPREVV suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ZYPREXA RELPREVV DMF (Drug Master File) is a document detailing the whole manufacturing process of ZYPREXA RELPREVV active pharmaceutical ingredient (API) in detail. Different forms of ZYPREXA RELPREVV DMFs exist exist since differing nations have different regulations, such as ZYPREXA RELPREVV USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ZYPREXA RELPREVV DMF submitted to regulatory agencies in the US is known as a USDMF. ZYPREXA RELPREVV USDMF includes data on ZYPREXA RELPREVV's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ZYPREXA RELPREVV USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ZYPREXA RELPREVV 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 ZYPREXA RELPREVV Drug Master File in Japan (ZYPREXA RELPREVV JDMF) empowers ZYPREXA RELPREVV 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 ZYPREXA RELPREVV JDMF during the approval evaluation for pharmaceutical products. At the time of ZYPREXA RELPREVV 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 ZYPREXA RELPREVV 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 ZYPREXA RELPREVV Drug Master File in Korea (ZYPREXA RELPREVV KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ZYPREXA RELPREVV. The MFDS reviews the ZYPREXA RELPREVV KDMF as part of the drug registration process and uses the information provided in the ZYPREXA RELPREVV KDMF to evaluate the safety and efficacy of the drug.
After submitting a ZYPREXA RELPREVV 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 ZYPREXA RELPREVV API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ZYPREXA RELPREVV suppliers with KDMF on PharmaCompass.
A ZYPREXA RELPREVV CEP of the European Pharmacopoeia monograph is often referred to as a ZYPREXA RELPREVV Certificate of Suitability (COS). The purpose of a ZYPREXA RELPREVV CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ZYPREXA RELPREVV EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ZYPREXA RELPREVV to their clients by showing that a ZYPREXA RELPREVV CEP has been issued for it. The manufacturer submits a ZYPREXA RELPREVV CEP (COS) as part of the market authorization procedure, and it takes on the role of a ZYPREXA RELPREVV CEP holder for the record. Additionally, the data presented in the ZYPREXA RELPREVV CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ZYPREXA RELPREVV DMF.
A ZYPREXA RELPREVV CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ZYPREXA RELPREVV 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 ZYPREXA RELPREVV suppliers with CEP (COS) on PharmaCompass.
A ZYPREXA RELPREVV written confirmation (ZYPREXA RELPREVV WC) is an official document issued by a regulatory agency to a ZYPREXA RELPREVV manufacturer, verifying that the manufacturing facility of a ZYPREXA RELPREVV active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ZYPREXA RELPREVV APIs or ZYPREXA RELPREVV finished pharmaceutical products to another nation, regulatory agencies frequently require a ZYPREXA RELPREVV WC (written confirmation) as part of the regulatory process.
click here to find a list of ZYPREXA RELPREVV 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 ZYPREXA RELPREVV as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ZYPREXA RELPREVV 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 ZYPREXA RELPREVV 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 ZYPREXA RELPREVV and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ZYPREXA RELPREVV NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ZYPREXA RELPREVV suppliers with NDC on PharmaCompass.
ZYPREXA RELPREVV 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 ZYPREXA RELPREVV 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 ZYPREXA RELPREVV GMP manufacturer or ZYPREXA RELPREVV GMP API supplier for your needs.
A ZYPREXA RELPREVV CoA (Certificate of Analysis) is a formal document that attests to ZYPREXA RELPREVV's compliance with ZYPREXA RELPREVV specifications and serves as a tool for batch-level quality control.
ZYPREXA RELPREVV CoA mostly includes findings from lab analyses of a specific batch. For each ZYPREXA RELPREVV 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.
ZYPREXA RELPREVV may be tested according to a variety of international standards, such as European Pharmacopoeia (ZYPREXA RELPREVV EP), ZYPREXA RELPREVV JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ZYPREXA RELPREVV USP).
