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Chemistry

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Also known as: Sandostatin, 79517-01-4, Nsc672461, Sandostatin (tn), 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, Octreotide acetate (usp)
Molecular Formula
C51H70N10O12S2
Molecular Weight
1079.3  g/mol
InChI Key
XQEJFZYLWPSJOV-UHFFFAOYSA-N

Octreotide Acetate
A potent, long-acting synthetic SOMATOSTATIN octapeptide analog that inhibits secretion of GROWTH HORMONE and is used to treat hormone-secreting tumors; DIABETES MELLITUS; HYPOTENSION, ORTHOSTATIC; HYPERINSULINISM; hypergastrinemia; and small bowel fistula.
1 2D Structure

Octreotide Acetate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
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
2.1.2 InChI
InChI=1S/C49H66N10O10S2.C2H4O2/c1-28(61)39(25-60)56-48(68)41-27-71-70-26-40(57-43(63)34(51)21-30-13-5-3-6-14-30)47(67)54-37(22-31-15-7-4-8-16-31)45(65)55-38(23-32-24-52-35-18-10-9-17-33(32)35)46(66)53-36(19-11-12-20-50)44(64)59-42(29(2)62)49(69)58-41;1-2(3)4/h3-10,13-18,24,28-29,34,36-42,52,60-62H,11-12,19-23,25-27,50-51H2,1-2H3,(H,53,66)(H,54,67)(H,55,65)(H,56,68)(H,57,63)(H,58,69)(H,59,64);1H3,(H,3,4)
2.1.3 InChI Key
XQEJFZYLWPSJOV-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C1C(=O)NC(CSSCC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)N1)CCCCN)CC2=CNC3=CC=CC=C32)CC4=CC=CC=C4)NC(=O)C(CC5=CC=CC=C5)N)C(=O)NC(CO)C(C)O)O.CC(=O)O
2.2 Synonyms
2.2.1 MeSH Synonyms

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

2.2.2 Depositor-Supplied Synonyms

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

2.3 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 1079.3 g/mol
Molecular Formula C51H70N10O12S2
Hydrogen Bond Donor Count14
Hydrogen Bond Acceptor Count16
Rotatable Bond Count17
Exact Mass1078.46161005 g/mol
Monoisotopic Mass1078.46161005 g/mol
Topological Polar Surface Area420 Ų
Heavy Atom Count75
Formal Charge0
Complexity1780
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count10
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameOctreotide acetate
Drug LabelOctreotide 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 IngredientOctreotide acetate
Dosage FormInjectable
RouteInjection
Strengtheq 0.2mg base/ml; eq 1mg base/ml; eq 0.1mg base/ml; eq 0.05mg base/ml; eq 0.5mg base/ml
Market StatusPrescription
CompanySun Pharm Inds; Teva Pharms Usa; Fresenius Kabi Usa; Sagent Pharms; Eurohlth Intl; Wockhardt Usa

2 of 6  
Drug NameSandostatin
PubMed HealthOctreotide (Injection)
Drug ClassesEndocrine-Metabolic Agent
Drug LabelSandostatin (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 IngredientOctreotide acetate
Dosage FormInjectable
RouteInjection
Strengtheq 0.2mg base/ml; eq 1mg base/ml; eq 0.1mg base/ml; eq 0.05mg base/ml; eq 0.5mg base/ml
Market StatusPrescription
CompanyNovartis

3 of 6  
Drug NameSandostatin lar
Active IngredientOctreotide acetate
Dosage FormInjectable
RouteInjection
Strengtheq 30mg base/vial; eq 10mg base/vial; eq 20mg base/vial
Market StatusPrescription
CompanyNovartis

4 of 6  
Drug NameOctreotide acetate
Drug LabelOctreotide 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 IngredientOctreotide acetate
Dosage FormInjectable
RouteInjection
Strengtheq 0.2mg base/ml; eq 1mg base/ml; eq 0.1mg base/ml; eq 0.05mg base/ml; eq 0.5mg base/ml
Market StatusPrescription
CompanySun Pharm Inds; Teva Pharms Usa; Fresenius Kabi Usa; Sagent Pharms; Eurohlth Intl; Wockhardt Usa

5 of 6  
Drug NameSandostatin
PubMed HealthOctreotide (Injection)
Drug ClassesEndocrine-Metabolic Agent
Drug LabelSandostatin (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 IngredientOctreotide acetate
Dosage FormInjectable
RouteInjection
Strengtheq 0.2mg base/ml; eq 1mg base/ml; eq 0.1mg base/ml; eq 0.05mg base/ml; eq 0.5mg base/ml
Market StatusPrescription
CompanyNovartis

6 of 6  
Drug NameSandostatin lar
Active IngredientOctreotide acetate
Dosage FormInjectable
RouteInjection
Strengtheq 30mg base/vial; eq 10mg base/vial; eq 20mg base/vial
Market StatusPrescription
CompanyNovartis

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


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Octreotide acetate

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Octreotide acetate "CHEMI"

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Octreotide Acetate

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RELIANCEPETROL PUMP, NR.PRAHLAD NAGAR","city":"GARDEN SATELLITE, AHMEDABAD-GUJARAT","supplier":"BCN PEPTIDES","supplierCountry":"SPAIN","foreign_port":"#N\/A","customer":"SWISS PARENTERALS LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"3","unit":"GMS","unitRateFc":"1000","totalValueFC":"3607.4","currency":"EUR","unitRateINR":"88450","date":"25-Sep-2021","totalValueINR":"265350","totalValueInUsd":"3607.4","indian_port":"AHMEDABAD AIR","hs_no":"29371900","bill_no":"5587722","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"#N\/A","supplierAddress":"","customerAddress":"303-304, SAMAAN-II, OPP. RELIANCEPETROL PUMP, NR.PRAHLAD NAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643049000,"product":"OCTREOTIDE ACETATE (TEST LIC NO. TL\/AZ\/21\/000039) (QTY : 46G) FOR R&D PURPOSE NOT FOR SALE","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"JIANGSU SINOPEP ALLSINO BIOPHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"46","unit":"GMS","unitRateFc":"250","totalValueFC":"12164.4","currency":"USD","unitRateINR":"19699.3","date":"25-Jan-2022","totalValueINR":"906168.97","totalValueInUsd":"12164.4","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"7233463","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1651170600,"product":"OCTREOTIDE ACETATE (TEST LIC - TL\/AZ\/22\/000511) FOR R&D PURPOSE NOT FOR SALE","address":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE","city":"AHMEDABAD","supplier":"JIANGSU SINOPEP ALLSINO BIOPHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"0.07","actualQuantity":"69","unit":"GMS","unitRateFc":"250","totalValueFC":"19377.2","currency":"USD","unitRateINR":"21188.3","date":"29-Apr-2022","totalValueINR":"1461992.5","totalValueInUsd":"19377.2","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"8483528","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ZYDUS CORPORATE PARK, SCHEME NO 63, KHORAJ (GANDHINAGAR), NR. VAISHNODE"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1656095400,"product":"OCTREOTIDE ACETATE (USP, PH. EUR.)","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"BACHEM AG","supplierCountry":"SWITZERLAND","foreign_port":"BASEL","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.25","actualQuantity":"250","unit":"GMS","unitRateFc":"400","totalValueFC":"101198.1","currency":"USD","unitRateINR":"31580","date":"25-Jun-2022","totalValueINR":"7895000","totalValueInUsd":"101198.1","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29371900","bill_no":"1002571","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"BASEL","supplierAddress":"HAUPTSTRASSE 144 4416 BUBENDORF SCHWEIZ SWITZERLAND","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1662661800,"product":"(FOC) - OCTREOTIDE ACETATE (USP,.PH.EUR) - 4081048 - 1000052970","address":"NO.54\/1, BOODIHAL,,NELAMANGALA,","city":"BENGALURU,KARNATAKA","supplier":"BACHEM AG","supplierCountry":"SWITZERLAND","foreign_port":"NA","customer":"SOMERSET THERAPEUTICS LIMITED","customerCountry":"INDIA","quantity":"0.31","actualQuantity":"310","unit":"GMS","unitRateFc":"408","totalValueFC":"129273.9","currency":"USD","unitRateINR":"33419.8","date":"09-Sep-2022","totalValueINR":"10360145.41","totalValueInUsd":"129273.9","indian_port":"BANGALORE AIR","hs_no":"29371900","bill_no":"2373709","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NO.54\/1, BOODIHAL,,NELAMANGALA,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1662661800,"product":"(FOC) - OCTREOTIDE ACETATE (USP,.PH.EUR) - 4081048 - 1000053498","address":"NO.54\/1, BOODIHAL,,NELAMANGALA,","city":"BENGALURU,KARNATAKA","supplier":"BACHEM AG","supplierCountry":"SWITZERLAND","foreign_port":"NA","customer":"SOMERSET THERAPEUTICS LIMITED","customerCountry":"INDIA","quantity":"0.14","actualQuantity":"140","unit":"GMS","unitRateFc":"408","totalValueFC":"58381.8","currency":"USD","unitRateINR":"33419.8","date":"09-Sep-2022","totalValueINR":"4678775.34","totalValueInUsd":"58381.8","indian_port":"BANGALORE AIR","hs_no":"29371900","bill_no":"2373709","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NO.54\/1, BOODIHAL,,NELAMANGALA,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1675017000,"product":"4081048 OCTREOTIDE ACETATE (USP,PH,EUR.)API 1000038742 FREESAMPLE,NCV","address":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9","city":"AHMEDABAD","supplier":"BACHEM AG","supplierCountry":"SWITZERLAND","foreign_port":"NA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0003","unit":"KGS","unitRateFc":"1000000","totalValueFC":"365.8","currency":"USD","unitRateINR":"99685866.7","date":"30-Jan-2023","totalValueINR":"29905.76","totalValueInUsd":"365.8","indian_port":"AHMEDABAD AIR","hs_no":"29371900","bill_no":"4403773","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"901-911 9TH FLR ISCON ELEGANCE NR SHAPATH 5 S G HIGHWAY Contact No: 9"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678213800,"product":"OCTREOTIDE ACETATE","address":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham","city":"HYDERABAD","supplier":"JIANGSU SINOPEP ALLSINO BIOPHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"GLAND PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"205","totalValueFC":"104078.2","currency":"USD","unitRateINR":"17120.9","date":"08-Mar-2023","totalValueINR":"8560467.48","totalValueInUsd":"104078.2","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"4952488","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Part of Plot No.11 & 87, Sy No.119 Phase - IV, Extension in IP, Pasham"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1684434600,"product":"OCTREOTIDE ACETATE 50 GM","address":"T-184, MIDC, BHOSARI PUNE","city":"PUNE","supplier":"SHENZHEN SIJIA PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"EMCURE PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"0.05","unit":"KGS","unitRateFc":"230000","totalValueFC":"11642","currency":"USD","unitRateINR":"19159000","date":"19-May-2023","totalValueINR":"957950","totalValueInUsd":"11642","indian_port":"BOMBAY AIR","hs_no":"29371900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"China","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"","customerAddress":"T-184, MIDC, BHOSARI PUNE"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691605800,"product":"2-7 TRISULFIDE- OCTREOTIDE CAS:1546983-27-0 0.5 GRM 1 BOTTLE","address":"ALEMBIC ROAD,","city":"VADODARA","supplier":"CHEMTOUR BIOTECH SUZHOU CO LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"7510000","totalValueFC":"3782","currency":"USD","unitRateINR":"31015726.2","date":"10-Aug-2023","totalValueINR":"313290.164","totalValueInUsd":"3782","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"ALEMBIC ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691605800,"product":"OCTREOTIDE ACETATE USP, PH, EUR, ARTICLE \/ ODS \/ PRODUCT \/ ITEM NO:4081048, LOT NO:1000053498 5 GMS","address":"901-911 9TH FLR ISCON ELEGANCE NR, SHAPATH 5 S G HIGHWAY","city":"AHMEDABAD","supplier":"BACHEM AG","supplierCountry":"SWITZERLAND","foreign_port":"NA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"290000","totalValueFC":"3273.4","currency":"USD","unitRateINR":"26844503.4","date":"10-Aug-2023","totalValueINR":"271156.6","totalValueInUsd":"3273.4","indian_port":"AHEMDABAD AIR","hs_no":"29371900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"901-911 9TH FLR ISCON ELEGANCE NR, SHAPATH 5 S G HIGHWAY"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695321000,"product":"OCTREOTIDE ACETATE (QTY: 2 X 0.06 GMS, VALUE: USD 47.18\/EACH) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL ","supplierCountry":"IRELAND","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00012","unit":"KGS","unitRateFc":"786333.3","totalValueFC":"99.5","currency":"USD","unitRateINR":"68822500","date":"22-Sep-2023","totalValueINR":"8258.7","totalValueInUsd":"99.5","indian_port":"Hyderabad Air","hs_no":"29371900","bill_no":"7944668","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD, US 21704SDNF United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695321000,"product":"OCTREOTIDE ACETATE (QTY: 2 X 0.08 GMS, VALUE: USD 58.68\/EACH) (FOC)","address":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL ","supplierCountry":"IRELAND","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00016","unit":"KGS","unitRateFc":"733500","totalValueFC":"123.7","currency":"USD","unitRateINR":"64198375","date":"22-Sep-2023","totalValueINR":"10271.74","totalValueInUsd":"123.7","indian_port":"Hyderabad Air","hs_no":"29371900","bill_no":"7944668","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD, US 21704SDNF United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1714329000,"product":"OCTREOTIDE ACETATE USP PH EUR","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"BACHEM AG","supplierCountry":"SWITZERLAND","foreign_port":"BASEL","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.60","actualQuantity":"600","unit":"GMS","unitRateFc":"290","totalValueFC":"175860.1","currency":"USD","unitRateINR":"24476","date":"29-Apr-2024","totalValueINR":"14685600","totalValueInUsd":"175860.1","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29371900","bill_no":"1001560","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"BASEL","supplierAddress":"HAUPTSTRASSE 144 CH-4416 BUBENDORF CH","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734892200,"product":"OCTREOTIDE ACETATE (USP PH EUR) LOT NO: 1000103701","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"N\/A","supplierCountry":"SWITZERLAND","foreign_port":"BASEL, BS","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"219923.1","totalValueFC":"222462.2","currency":"USD","unitRateINR":"18902389","date":"23-Dec-2024","totalValueINR":"18902389","totalValueInUsd":"222462.2","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29371900","bill_no":"7402370","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"BASEL, BS","supplierAddress":"N\/A","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"}]
11-Jan-2021
13-Feb-2025
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

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Quantity (KGS) & Unit rate (USD/KGS) over time

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API Imports and Exports

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FDF Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Injectable Suspension

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Injectable Suspension

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Injectable Suspension

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 50MCG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Naprod Life Sciences

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 100MCG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Naprod Life Sciences

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 200MCG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Naprod Life Sciences

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 500MCG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Naprod Life Sciences

08

AAPS National Biotech
Not Confirmed
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AAPS National Biotech
Not Confirmed

Octreotidum

Brand Name : Sandostatin

Dosage Form : Inj L?s

Dosage Strength : 0.1mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

AAPS National Biotech
Not Confirmed
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AAPS National Biotech
Not Confirmed

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

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10

AAPS National Biotech
Not Confirmed
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AAPS National Biotech
Not Confirmed

OCTREOTIDE ACETATE

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

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Canada

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01

Arvo
Not Confirmed
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Arvo
Not Confirmed

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

blank

02

Arvo
Not Confirmed
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Arvo
Not Confirmed

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

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03

Arvo
Not Confirmed
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Arvo
Not Confirmed

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

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04

Arvo
Not Confirmed
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Arvo
Not Confirmed

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

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05

Arvo
Not Confirmed
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Arvo
Not Confirmed

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

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06

Arvo
Not Confirmed
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Arvo
Not Confirmed

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

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07

Arvo
Not Confirmed
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Arvo
Not Confirmed

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

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08

Arvo
Not Confirmed
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Arvo
Not Confirmed

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

blank

09

Arvo
Not Confirmed
arrow
arrow
Arvo
Not Confirmed

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

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10

Arvo
Not Confirmed
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Arvo
Not Confirmed

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

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Octreotide

Brand Name : Octreotide Acetate Omega (Canada)

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Packaging : 5

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Registration Country : Australia

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Octreotide

Brand Name : Octreotide GH

Dosage Form : injection

Dosage Strength : 500 microgram/mL

Packaging : 5

Approval Date :

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Regulatory Info :

Registration Country : Australia

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Octreotide

Brand Name : Octreotide (SUN)

Dosage Form : injection

Dosage Strength : 50 microgram/mL

Packaging : 5

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Regulatory Info :

Registration Country : Australia

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Octreotide

Brand Name : Octreotide (SUN)

Dosage Form : injection

Dosage Strength : 50 microgram/mL

Packaging : 5

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Registration Country : Australia

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Brand Name : Octreotide Depot

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Registration Country : Australia

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Octreotide

Brand Name : Sandostatin LAR

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Packaging : 1

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Registration Country : Australia

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Brand Name : Sandostatin LAR

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Brand Name : Sandostatin LAR

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Packaging : 1

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Registration Country : Australia

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Octreotide

Brand Name : Sandostatin 0.05

Dosage Form : injection

Dosage Strength : 50 microgram/mL

Packaging : 5

Approval Date :

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Regulatory Info :

Registration Country : Australia

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Octreotide

Brand Name : Sandostatin 0.5

Dosage Form : injection

Dosage Strength : 500 microgram/mL

Packaging : 5

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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OCTREOTIDE

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

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OCTREOTIDE

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

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Octreotide

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

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Octreotide

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

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Octreotide

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

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Octreotide

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

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Octreotide

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

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Octreotide

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

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Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Injectable Suspension

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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Digital Content Digital Content

Packaging :

Regulatory Info :

Octreotide Acetate

Dosage : Injectable Suspension

Dosage Strength : 10MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Omgene Company Banner

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  • fda
  • EDQM
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Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Injectable Suspension

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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Packaging :

Regulatory Info :

Octreotide Acetate

Dosage : Injectable Suspension

Dosage Strength : 20MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Omgene Company Banner

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  • fda
  • EDQM
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Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Injectable Suspension

Dosage Strength : 30MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Octreotide Acetate

Dosage : Injectable Suspension

Dosage Strength : 30MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Omgene Company Banner

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

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Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 50MCG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Naprod Life Sciences

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

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Digital Content Digital Content

Packaging :

Regulatory Info :

Octreotide Acetate

Dosage : Lyophilised Injection

Dosage Strength : 50MCG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Naprod Life Sciences

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  • fda
  • EDQM
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Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

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Digital Content Digital Content

Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 100MCG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Naprod Life Sciences

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

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Digital Content Digital Content

Packaging :

Regulatory Info :

Octreotide Acetate

Dosage : Lyophilised Injection

Dosage Strength : 100MCG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Naprod Life Sciences

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

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Digital Content Digital Content

Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 200MCG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Naprod Life Sciences

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Octreotide Acetate

Dosage : Lyophilised Injection

Dosage Strength : 200MCG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Naprod Life Sciences

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Octreotide Acetate

Brand Name :

Dosage Form : Lyophilised Injection

Dosage Strength : 500MCG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Naprod Life Sciences

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNaprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Octreotide Acetate

Dosage : Lyophilised Injection

Dosage Strength : 500MCG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Naprod Life Sciences

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OCTREOTIDE ACETATE

Brand Name :

Dosage Form : Injection

Dosage Strength : 5MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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OCTREOTIDE ACETATE

Dosage : Injection

Dosage Strength : 5MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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Octreotide

Brand Name :

Dosage Form : Vial

Dosage Strength : 10MG

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Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Octreotide

Dosage : Vial

Dosage Strength : 10MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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Pluviaendo

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Octreotide Acetate

Brand Name :

Dosage Form : Pre-Filled Syringe

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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Octreotide Acetate

Dosage : Pre-Filled Syringe

Dosage Strength : 20MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Turkey

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - EQ 0.05MG BAS...DOSAGE - INJECTABLE;INJECTION - EQ 0.05MG BASE/ML

USFDA APPLICATION NUMBER - 19667

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DOSAGE - INJECTABLE;INJECTION - EQ 0.1MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.1MG BASE/ML

USFDA APPLICATION NUMBER - 19667

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DOSAGE - INJECTABLE;INJECTION - EQ 0.2MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19667

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DOSAGE - INJECTABLE;INJECTION - EQ 0.5MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.5MG BASE/ML

USFDA APPLICATION NUMBER - 19667

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DOSAGE - INJECTABLE;INJECTION - EQ 1MG BASE/M...DOSAGE - INJECTABLE;INJECTION - EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19667

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DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 7MG BASE/...DOSAGE - SOLUTION;SUBCUTANEOUS - EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)

USFDA APPLICATION NUMBER - 213224

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ABOUT THIS PAGE

Looking for 79517-01-4 / Octreotide Acetate API manufacturers, exporters & distributors?

Octreotide Acetate manufacturers, exporters & distributors 1

100

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.

API | Excipient name

Octreotide Acetate

Synonyms

Sandostatin, 79517-01-4, Nsc672461, Sandostatin (tn), 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, Octreotide acetate (usp)

Cas Number

79517-01-4

About Octreotide Acetate

A potent, long-acting synthetic SOMATOSTATIN octapeptide analog that inhibits secretion of GROWTH HORMONE and is used to treat hormone-secreting tumors; DIABETES MELLITUS; HYPOTENSION, ORTHOSTATIC; HYPERINSULINISM; hypergastrinemia; and small bowel fistula.

Octreotide Acetate Manufacturers

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.

Octreotide Acetate Suppliers

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.

Octreotide Acetate USDMF

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.

Octreotide Acetate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The 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.

Octreotide Acetate KDMF

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.

Octreotide Acetate CEP

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.

Octreotide Acetate WC

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.

Octreotide Acetate NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Octreotide Acetate as an active pharmaceutical ingredient (API).

Finished drug products

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.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture 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.

Compounded drug products

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 GMP

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.

Octreotide Acetate CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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