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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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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
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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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