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1. Compound 201 995
2. Compound 201-995
3. Compound 201995
4. Octreotide
5. Octreotide Acetate
6. Octreotide Acetate Salt
7. San 201 995
8. San 201-995
9. San 201995
10. Sandostatin
11. Sandostatine
12. Sandoz 201 995
13. Sandoz 201-995
14. Sandoz 201995
15. Sm 201 995
16. Sm 201-995
17. Sm 201995
18. Sms 201 995
19. Sms 201-995
20. Sms 201995
1. Sandostatin
2. 79517-01-4
3. Nsc672461
4. Sandostatin (tn)
5. Acetic Acid;10-(4-aminobutyl)-19-[(2-amino-3-phenylpropanoyl)amino]-16-benzyl-n-(1,3-dihydroxybutan-2-yl)-7-(1-hydroxyethyl)-13-(1h-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carboxamide
6. Octreotide Acetate (usp)
7. Schembl58453
8. Chembl2000504
9. Hms3748c05
10. Bcp04661
11. Nsc671663
12. Nsc-671663
13. Nsc-672461
14. Acetic Acid;(4r,7s,10s,13r,16s,19r)-10-(4-aminobutyl)-19-[[(2r)-2-amino-3-phenylpropanoyl]amino]-16-benzyl-n-[(2r,3r)-1,3-dihydroxybutan-2-yl]-7-[(1r)-1-hydroxyethyl]-13-(1h-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carboxamide
15. D-phenylalanyl-l-cysteinyl-l-phenylalanyl-d-tryptophyl-l-lysyl-l-threonyl-n-[(1r,2r)-2-hydroxy-1-(hydroxymethyl)propyl]-l-cysteinamide Cyclic (2-7)-disulfide Acetate
16. 10-(4-aminobutyl)-19-((2-amino-3-phenylpropanoyl)amino)-16-benzyl-7-(1-hydroxyethyl)-n-(2-hydroxy-1-(hydroxymethyl)propyl)-13-(1h-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosane-4-carboxamide Acetate
17. D06495
18. 10-(4-aminobutyl)-19-[(2-amino-3-phenyl-propanoyl)amino]-16-benzyl-7-(1-hydroxyethyl)-n-[2-hydroxy-1-(hydroxymethyl)propyl]-13-(1h-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carboxamide
19. D-phenylalanyl-l-hemicystyl-l-phenylalanyl-d-trytophyl-l-lysyl-l-threonyl-l-hemicystyl-l-threoninol, Acetate
Molecular Weight | 1079.3 g/mol |
---|---|
Molecular Formula | C51H70N10O12S2 |
Hydrogen Bond Donor Count | 14 |
Hydrogen Bond Acceptor Count | 16 |
Rotatable Bond Count | 17 |
Exact Mass | 1078.46161005 g/mol |
Monoisotopic Mass | 1078.46161005 g/mol |
Topological Polar Surface Area | 420 Ų |
Heavy Atom Count | 75 |
Formal Charge | 0 |
Complexity | 1780 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 10 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 6 | |
---|---|
Drug Name | Octreotide acetate |
Drug Label | Octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered acetate solution for administration by deep subcutaneous (intrafat) or intravenous injection. Octreotide acetate, known... |
Active Ingredient | Octreotide acetate |
Dosage Form | Injectable |
Route | Injection |
Strength | eq 0.2mg base/ml; eq 1mg base/ml; eq 0.1mg base/ml; eq 0.05mg base/ml; eq 0.5mg base/ml |
Market Status | Prescription |
Company | Sun Pharm Inds; Teva Pharms Usa; Fresenius Kabi Usa; Sagent Pharms; Eurohlth Intl; Wockhardt Usa |
2 of 6 | |
---|---|
Drug Name | Sandostatin |
PubMed Health | Octreotide (Injection) |
Drug Classes | Endocrine-Metabolic Agent |
Drug Label | Sandostatin (octreotide acetate) Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous (intrafat) or intravenous injection. Octre... |
Active Ingredient | Octreotide acetate |
Dosage Form | Injectable |
Route | Injection |
Strength | eq 0.2mg base/ml; eq 1mg base/ml; eq 0.1mg base/ml; eq 0.05mg base/ml; eq 0.5mg base/ml |
Market Status | Prescription |
Company | Novartis |
3 of 6 | |
---|---|
Drug Name | Sandostatin lar |
Active Ingredient | Octreotide acetate |
Dosage Form | Injectable |
Route | Injection |
Strength | eq 30mg base/vial; eq 10mg base/vial; eq 20mg base/vial |
Market Status | Prescription |
Company | Novartis |
4 of 6 | |
---|---|
Drug Name | Octreotide acetate |
Drug Label | Octreotide acetate injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered acetate solution for administration by deep subcutaneous (intrafat) or intravenous injection. Octreotide acetate, known... |
Active Ingredient | Octreotide acetate |
Dosage Form | Injectable |
Route | Injection |
Strength | eq 0.2mg base/ml; eq 1mg base/ml; eq 0.1mg base/ml; eq 0.05mg base/ml; eq 0.5mg base/ml |
Market Status | Prescription |
Company | Sun Pharm Inds; Teva Pharms Usa; Fresenius Kabi Usa; Sagent Pharms; Eurohlth Intl; Wockhardt Usa |
5 of 6 | |
---|---|
Drug Name | Sandostatin |
PubMed Health | Octreotide (Injection) |
Drug Classes | Endocrine-Metabolic Agent |
Drug Label | Sandostatin (octreotide acetate) Injection, a cyclic octapeptide prepared as a clear sterile solution of octreotide, acetate salt, in a buffered lactic acid solution for administration by deep subcutaneous (intrafat) or intravenous injection. Octre... |
Active Ingredient | Octreotide acetate |
Dosage Form | Injectable |
Route | Injection |
Strength | eq 0.2mg base/ml; eq 1mg base/ml; eq 0.1mg base/ml; eq 0.05mg base/ml; eq 0.5mg base/ml |
Market Status | Prescription |
Company | Novartis |
6 of 6 | |
---|---|
Drug Name | Sandostatin lar |
Active Ingredient | Octreotide acetate |
Dosage Form | Injectable |
Route | Injection |
Strength | eq 30mg base/vial; eq 10mg base/vial; eq 20mg base/vial |
Market Status | Prescription |
Company | Novartis |
Gastrointestinal Agents
Drugs used for their effects on the gastrointestinal system, as to control gastric acidity, regulate gastrointestinal motility and water flow, and improve digestion. (See all compounds classified as Gastrointestinal Agents.)
Antineoplastic Agents, Hormonal
Antineoplastic agents that are used to treat hormone-sensitive tumors. Hormone-sensitive tumors may be hormone-dependent, hormone-responsive, or both. A hormone-dependent tumor regresses on removal of the hormonal stimulus, by surgery or pharmacological block. Hormone-responsive tumors may regress when pharmacologic amounts of hormones are administered regardless of whether previous signs of hormone sensitivity were observed. The major hormone-responsive cancers include carcinomas of the breast, prostate, and endometrium; lymphomas; and certain leukemias. (From AMA Drug Evaluations Annual 1994, p2079) (See all compounds classified as Antineoplastic Agents, Hormonal.)
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-09
Pay. Date : 2014-04-10
DMF Number : 16760
Submission : 2003-08-13
Status : Active
Type : II
Certificate Number : R0-CEP 2020-229 - Rev 01
Issue Date : 2022-07-18
Type : Chemical
Substance Number : 2414
Status : Valid
Registration Number : 306MF10083
Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland
Initial Date of Registration : 2024-07-03
Latest Date of Registration :
NDC Package Code : 55463-0038
Start Marketing Date : 2023-10-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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 : 2015-02-27
Pay. Date : 2012-11-09
DMF Number : 17777
Submission : 2004-10-21
Status : Active
Type : II
Available Reg Filing : ASMF |
Vtides Life Sciences: Innovating peptide design and synthesis for advanced, targeted therapies across key disease areas.
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-11-19
Pay. Date : 2019-09-19
DMF Number : 34145
Submission : 2019-09-27
Status : Active
Type : II
NDC Package Code : 52416-123
Start Marketing Date : 2020-06-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38662
Submission : 2023-10-23
Status : Active
Type : II
NDC Package Code : 55463-0035
Start Marketing Date : 2019-10-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-19
Pay. Date : 2019-09-19
DMF Number : 34145
Submission : 2019-09-27
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-09
Pay. Date : 2014-04-10
DMF Number : 16760
Submission : 2003-08-13
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38662
Submission : 2023-10-23
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-27
Pay. Date : 2012-11-09
DMF Number : 17777
Submission : 2004-10-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18740
Submission : 2005-09-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19567
Submission : 2006-06-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14994
Submission : 2000-08-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21704
Submission : 2008-06-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17678
Submission : 2004-09-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-16
Pay. Date : 2013-02-27
DMF Number : 24288
Submission : 2010-11-01
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
Registration Number : 306MF10083
Registrant's Address : Hauptstrasse 144,4416 Bubendorf Switzerland
Initial Date of Registration : 2024-07-03
Latest Date of Registration : 2024-07-03
Registration Number : 226MF10055
Registrant's Address : Viale dei Laboratori 54, 20092 Cinisello Balsamo (Milano) ITALY
Initial Date of Registration : 2014-03-06
Latest Date of Registration : 2014-03-06
Registration Number : 227MF10055
Registrant's Address : 1-4-29 Shibashima, Higashiyodogawa-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2015-02-18
Latest Date of Registration : 2015-02-18
Registration Number : 226MF10062
Registrant's Address : SUN HOUSE, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, Ma...
Initial Date of Registration : 2014-03-06
Latest Date of Registration : 2014-03-06
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Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injectable Suspension
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injectable Suspension
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injectable Suspension
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
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Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 50MCG/ML
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Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 100MCG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 200MCG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 500MCG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : Switzerland
Brand Name : Sandostatin
Dosage Form : Inj L?s
Dosage Strength : 0.1mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Prescription
Registration Country : Canada
OCTREOTIDE (OCTREOTIDE ACETATE)
Brand Name : SANDOSTATIN LAR
Dosage Form : POWDER FOR SUSPENSION, SUSTAINED-RELEASE
Dosage Strength : 30MG/VIAL
Packaging : 2ML
Approval Date :
Application Number : 2239325
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : DISCN
Registration Country : USA
Brand Name : OCTREOTIDE ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1MG BASE/ML
Packaging :
Approval Date : 2008-03-04
Application Number : 77331
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Prescription
Registration Country : Canada
OCTREOTIDE (OCTREOTIDE ACETATE)
Brand Name : SANDOSTATIN
Dosage Form : SOLUTION
Dosage Strength : 50MCG/ML
Packaging : 1ML
Approval Date :
Application Number : 839191
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
OCTREOTIDE (OCTREOTIDE ACETATE)
Brand Name : SANDOSTATIN LAR
Dosage Form : POWDER FOR SUSPENSION, SUSTAINED-RELEASE
Dosage Strength : 10MG/VIAL
Packaging : 2ML
Approval Date :
Application Number : 2239323
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
OCTREOTIDE (OCTREOTIDE ACETATE)
Brand Name : SANDOSTATIN LAR
Dosage Form : POWDER FOR SUSPENSION, SUSTAINED-RELEASE
Dosage Strength : 20MG/VIAL
Packaging : 2ML
Approval Date :
Application Number : 2239324
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
OCTREOTIDE (OCTREOTIDE ACETATE)
Brand Name : SANDOSTATIN LAR
Dosage Form : POWDER FOR SUSPENSION, SUSTAINED-RELEASE
Dosage Strength : 30MG/VIAL
Packaging : 2ML
Approval Date :
Application Number : 2239325
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
OCTREOTIDE (OCTREOTIDE ACETATE)
Brand Name : OCTREOTIDE ACETATE OMEGA
Dosage Form : SOLUTION
Dosage Strength : 50MCG/ML
Packaging : 1ML
Approval Date :
Application Number : 2248639
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
OCTREOTIDE (OCTREOTIDE ACETATE)
Brand Name : OCTREOTIDE ACETATE OMEGA
Dosage Form : SOLUTION
Dosage Strength : 100MCG/ML
Packaging : 1ML
Approval Date :
Application Number : 2248640
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
OCTREOTIDE (OCTREOTIDE ACETATE)
Brand Name : OCTREOTIDE ACETATE OMEGA
Dosage Form : SOLUTION
Dosage Strength : 500MCG/ML
Packaging : 1ML
Approval Date :
Application Number : 2248641
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
OCTREOTIDE (OCTREOTIDE ACETATE)
Brand Name : OCTREOTIDE ACETATE OMEGA
Dosage Form : SOLUTION
Dosage Strength : 200MCG/ML
Packaging : 5ML
Approval Date :
Application Number : 2248642
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
OCTREOTIDE (OCTREOTIDE ACETATE)
Brand Name : OCTREOTIDE FOR INJECTABLE SUSPENSION
Dosage Form : POWDER FOR SUSPENSION, SUSTAINED-RELEASE
Dosage Strength : 10MG/VIAL
Packaging :
Approval Date :
Application Number : 2503751
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
OCTREOTIDE (OCTREOTIDE ACETATE)
Brand Name : OCTREOTIDE FOR INJECTABLE SUSPENSION
Dosage Form : POWDER FOR SUSPENSION, SUSTAINED-RELEASE
Dosage Strength : 20MG/VIAL
Packaging :
Approval Date :
Application Number : 2503778
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Octreotide Acetate Omega (Canada)
Dosage Form :
Dosage Strength :
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Octreotide GH
Dosage Form : injection
Dosage Strength : 500 microgram/mL
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Octreotide (SUN)
Dosage Form : injection
Dosage Strength : 50 microgram/mL
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Octreotide (SUN)
Dosage Form : injection
Dosage Strength : 50 microgram/mL
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Octreotide Depot
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Sandostatin LAR
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Sandostatin LAR
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Sandostatin LAR
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Sandostatin 0.05
Dosage Form : injection
Dosage Strength : 50 microgram/mL
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Australia
Brand Name : Sandostatin 0.5
Dosage Form : injection
Dosage Strength : 500 microgram/mL
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : OCTREOTIDE TEVA 20
Dosage Form : INF
Dosage Strength : 20MG/2ML
Packaging : 2X1MG/2ML
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : OCTREOTIDE TEVA 30
Dosage Form : INF
Dosage Strength : 30MG/2ML
Packaging : 2X1MG/2ML
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Sandostatin Lar 10Mg
Dosage Form : INJ
Dosage Strength : 10mg
Packaging : 2.5X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Sandostatin Lar 20Mg
Dosage Form : INJ
Dosage Strength : 20mg
Packaging : 2.5X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Sandostatin Lar 30Mg
Dosage Form : INJ
Dosage Strength : 30mg
Packaging : 2.5X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Sandostatin
Dosage Form : INJ
Dosage Strength : 0.05mg/ml
Packaging : 1X5mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Sandostatin
Dosage Form : INJ
Dosage Strength : 0.1mg/ml
Packaging : 1X5mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Sandostatin 1Mg/5Ml Injection
Dosage Form : INJ
Dosage Strength : 1mg/ml
Packaging : 5X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injectable Suspension
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Packaging :
Regulatory Info :
Dosage : Injectable Suspension
Dosage Strength : 10MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injectable Suspension
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Packaging :
Regulatory Info :
Dosage : Injectable Suspension
Dosage Strength : 20MG
Brand Name :
Approval Date :
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Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injectable Suspension
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Packaging :
Regulatory Info :
Dosage : Injectable Suspension
Dosage Strength : 30MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 50MCG/ML
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Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Packaging :
Regulatory Info :
Dosage : Lyophilised Injection
Dosage Strength : 50MCG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 100MCG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Packaging :
Regulatory Info :
Dosage : Lyophilised Injection
Dosage Strength : 100MCG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 200MCG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Packaging :
Regulatory Info :
Dosage : Lyophilised Injection
Dosage Strength : 200MCG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 500MCG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Packaging :
Regulatory Info :
Dosage : Lyophilised Injection
Dosage Strength : 500MCG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 5MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 5MG/ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Vial
Dosage Strength : 10MG
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Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Vial
Dosage Strength : 10MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Turkey
Brand Name :
Dosage Form : Pre-Filled Syringe
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Packaging :
Regulatory Info :
Dosage : Pre-Filled Syringe
Dosage Strength : 20MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Turkey
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PharmaCompass offers a list of Octreotide Acetate 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 Octreotide Acetate manufacturer or Octreotide Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Octreotide Acetate manufacturer or Octreotide Acetate supplier.
PharmaCompass also assists you with knowing the Octreotide Acetate API Price utilized in the formulation of products. Octreotide Acetate API Price is not always fixed or binding as the Octreotide Acetate Price is obtained through a variety of data sources. The Octreotide Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Octreotide Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Octreotide Acetate, including repackagers and relabelers. The FDA regulates Octreotide Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Octreotide Acetate 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 Octreotide Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Octreotide Acetate supplier is an individual or a company that provides Octreotide Acetate active pharmaceutical ingredient (API) or Octreotide Acetate finished formulations upon request. The Octreotide Acetate suppliers may include Octreotide Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Octreotide Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Octreotide Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Octreotide Acetate active pharmaceutical ingredient (API) in detail. Different forms of Octreotide Acetate DMFs exist exist since differing nations have different regulations, such as Octreotide Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Octreotide Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Octreotide Acetate USDMF includes data on Octreotide Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Octreotide Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Octreotide Acetate 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 Octreotide Acetate Drug Master File in Japan (Octreotide Acetate JDMF) empowers Octreotide Acetate 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 Octreotide Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Octreotide Acetate 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 Octreotide Acetate 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 Octreotide Acetate Drug Master File in Korea (Octreotide Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Octreotide Acetate. The MFDS reviews the Octreotide Acetate KDMF as part of the drug registration process and uses the information provided in the Octreotide Acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Octreotide Acetate 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 Octreotide Acetate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Octreotide Acetate suppliers with KDMF on PharmaCompass.
A Octreotide Acetate CEP of the European Pharmacopoeia monograph is often referred to as a Octreotide Acetate Certificate of Suitability (COS). The purpose of a Octreotide Acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Octreotide Acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Octreotide Acetate to their clients by showing that a Octreotide Acetate CEP has been issued for it. The manufacturer submits a Octreotide Acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Octreotide Acetate CEP holder for the record. Additionally, the data presented in the Octreotide Acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Octreotide Acetate DMF.
A Octreotide Acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Octreotide Acetate 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 Octreotide Acetate suppliers with CEP (COS) on PharmaCompass.
A Octreotide Acetate written confirmation (Octreotide Acetate WC) is an official document issued by a regulatory agency to a Octreotide Acetate manufacturer, verifying that the manufacturing facility of a Octreotide Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Octreotide Acetate APIs or Octreotide Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Octreotide Acetate WC (written confirmation) as part of the regulatory process.
click here to find a list of Octreotide Acetate 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 Octreotide Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Octreotide Acetate 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 Octreotide Acetate 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 Octreotide Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Octreotide Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Octreotide Acetate suppliers with NDC on PharmaCompass.
Octreotide Acetate 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 Octreotide Acetate 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 Octreotide Acetate GMP manufacturer or Octreotide Acetate GMP API supplier for your needs.
A Octreotide Acetate CoA (Certificate of Analysis) is a formal document that attests to Octreotide Acetate's compliance with Octreotide Acetate specifications and serves as a tool for batch-level quality control.
Octreotide Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Octreotide Acetate 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.
Octreotide Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Octreotide Acetate EP), Octreotide Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Octreotide Acetate USP).