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    Chemistry

    Click the arrow to open the dropdown
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    Also known as: Nn9535, Ozempic, Rybelsus, 910463-68-2, Nn 9535, Nnc 0113-0217
    Molecular Formula
    C187H291N45O59
    Molecular Weight
    4114  g/mol
    InChI Key
    DLSWIYLPEUIQAV-CCUURXOWSA-N
    Semaglutide
    1 2D Structure

    Semaglutide

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    18-[[(1R)-4-[2-[2-[2-[2-[2-[2-[[(5S)-5-[[(2S)-2-[[(2S)-2-[[(2S)-5-amino-2-[[2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S)-2-[[(2S,3R)-2-[[(2S)-2-[[(2S,3R)-2-[[2-[[(2S)-2-[[2-[[(2S)-2-amino-3-(1H-imidazol-5-yl)propanoyl]amino]-2-methylpropanoyl]amino]-4-carboxybutanoyl]amino]acetyl]amino]-3-hydroxybutanoyl]amino]-3-phenylpropanoyl]amino]-3-hydroxybutanoyl]amino]-3-hydroxypropanoyl]amino]-3-carboxypropanoyl]amino]-3-methylbutanoyl]amino]-3-hydroxypropanoyl]amino]-3-hydroxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-4-methylpentanoyl]amino]-4-carboxybutanoyl]amino]acetyl]amino]-5-oxopentanoyl]amino]propanoyl]amino]propanoyl]amino]-6-[[(2S)-1-[[(2S)-1-[[(2S,3S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-1-[[(2S)-5-carbamimidamido-1-[[2-[[(2S)-5-carbamimidamido-1-(carboxymethylamino)-1-oxopentan-2-yl]amino]-2-oxoethyl]amino]-1-oxopentan-2-yl]amino]-3-methyl-1-oxobutan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-3-(1H-indol-3-yl)-1-oxopropan-2-yl]amino]-1-oxopropan-2-yl]amino]-3-methyl-1-oxopentan-2-yl]amino]-1-oxo-3-phenylpropan-2-yl]amino]-4-carboxy-1-oxobutan-2-yl]amino]-6-oxohexyl]amino]-2-oxoethoxy]ethoxy]ethylamino]-2-oxoethoxy]ethoxy]ethylamino]-1-carboxy-4-oxobutyl]amino]-18-oxooctadecanoic acid
    2.1.2 InChI
    InChI=1S/C187H291N45O59/c1-18-105(10)154(180(282)208-108(13)159(261)216-133(86-114-89-200-119-50-40-39-49-117(114)119)170(272)218-129(82-102(4)5)171(273)228-152(103(6)7)178(280)215-121(53-44-72-199-186(192)193)162(264)201-91-141(242)209-120(52-43-71-198-185(190)191)161(263)204-94-151(257)258)230-172(274)131(83-111-45-33-31-34-46-111)219-167(269)126(64-69-149(253)254)214-166(268)122(51-41-42-70-195-144(245)98-290-79-78-289-76-74-197-145(246)99-291-80-77-288-75-73-196-139(240)66-61-127(183(285)286)211-140(241)54-37-29-27-25-23-21-19-20-22-24-26-28-30-38-55-146(247)248)212-158(260)107(12)206-157(259)106(11)207-165(267)125(60-65-138(189)239)210-142(243)92-202-163(265)123(62-67-147(249)250)213-168(270)128(81-101(2)3)217-169(271)130(85-113-56-58-116(238)59-57-113)220-175(277)135(95-233)223-177(279)137(97-235)224-179(281)153(104(8)9)229-174(276)134(88-150(255)256)221-176(278)136(96-234)225-182(284)156(110(15)237)231-173(275)132(84-112-47-35-32-36-48-112)222-181(283)155(109(14)236)227-143(244)93-203-164(266)124(63-68-148(251)252)226-184(287)187(16,17)232-160(262)118(188)87-115-90-194-100-205-115/h31-36,39-40,45-50,56-59,89-90,100-110,118,120-137,152-156,200,233-238H,18-30,37-38,41-44,51-55,60-88,91-99,188H2,1-17H3,(H2,189,239)(H,194,205)(H,195,245)(H,196,240)(H,197,246)(H,201,264)(H,202,265)(H,203,266)(H,204,263)(H,206,259)(H,207,267)(H,208,282)(H,209,242)(H,210,243)(H,211,241)(H,212,260)(H,213,270)(H,214,268)(H,215,280)(H,216,261)(H,217,271)(H,218,272)(H,219,269)(H,220,277)(H,221,278)(H,222,283)(H,223,279)(H,224,281)(H,225,284)(H,226,287)(H,227,244)(H,228,273)(H,229,276)(H,230,274)(H,231,275)(H,232,262)(H,247,248)(H,249,250)(H,251,252)(H,253,254)(H,255,256)(H,257,258)(H,285,286)(H4,190,191,198)(H4,192,193,199)/t105-,106-,107-,108-,109+,110+,118-,120-,121-,122-,123-,124-,125-,126-,127+,128-,129-,130-,131-,132-,133-,134-,135-,136-,137-,152-,153-,154-,155-,156-/m0/s1
    2.1.3 InChI Key
    DLSWIYLPEUIQAV-CCUURXOWSA-N
    2.1.4 Canonical SMILES
    CCC(C)C(C(=O)NC(C)C(=O)NC(CC1=CNC2=CC=CC=C21)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)NC(=O)C(CC3=CC=CC=C3)NC(=O)C(CCC(=O)O)NC(=O)C(CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CCC(C(=O)O)NC(=O)CCCCCCCCCCCCCCCCC(=O)O)NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(=O)N)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CC4=CC=C(C=C4)O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(C(C)C)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CC5=CC=CC=C5)NC(=O)C(C(C)O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)(C)NC(=O)C(CC6=CN=CN6)N
    2.1.5 Isomeric SMILES
    CC[C@H](C)[C@@H](C(=O)N[C@@H](C)C(=O)N[C@@H](CC1=CNC2=CC=CC=C21)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)O)NC(=O)[C@H](CC3=CC=CC=C3)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CC[C@H](C(=O)O)NC(=O)CCCCCCCCCCCCCCCCC(=O)O)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)N)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC4=CC=C(C=C4)O)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CC5=CC=CC=C5)NC(=O)[C@H]([C@@H](C)O)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)C(C)(C)NC(=O)[C@H](CC6=CN=CN6)N
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Ozempic

    2. Rybelsus

    2.2.2 Depositor-Supplied Synonyms

    1. Nn9535

    2. Ozempic

    3. Rybelsus

    4. 910463-68-2

    5. Nn 9535

    6. Nnc 0113-0217

    7. Nn-9535

    8. Unii-53axn4nnhx

    9. Semaglutide [usan:inn]

    10. Wegovy

    11. 53axn4nnhx

    12. Rybelsus (oral Semaglutide)

    13. Gtpl9724

    14. Ozempic (injectable Semaglutide)

    15. Chebi:167574

    16. Ex-a2424

    17. Ac-32580

    18. Nnc-0113-0217

    19. Rybelsus;ozempic;nn9535;og217sc;nnc 0113-0217

    2.3 Create Date
    2012-03-21
    3 Chemical and Physical Properties
    Molecular Weight 4114 g/mol
    Molecular Formula C187H291N45O59
    XLogP3-5.8
    Hydrogen Bond Donor Count57
    Hydrogen Bond Acceptor Count63
    Rotatable Bond Count151
    Exact Mass4112.1187318 g/mol
    Monoisotopic Mass4111.1153770 g/mol
    Topological Polar Surface Area1650 Ų
    Heavy Atom Count291
    Formal Charge0
    Complexity9590
    Isotope Atom Count0
    Defined Atom Stereocenter Count30
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

    - as monotherapy when metformin is considered inappropriate due to intolerance or contraindications;

    - in addition to other medicinal products for the treatment of diabetes.

    For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4. 4, 4. 5 and 5. 1.

    Treatment of obesity

    Treatment of type II diabetes mellitus

    Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise

    - as monotherapy when metformin is considered inappropriate due to intolerance or contraindications

    - in combination with other medicinal products for the treatment of diabetes.

    For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4. 4, 4. 5 and 5. 1.

    Treatment of type II diabetes mellitus

    Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of

    - 30 kg/m (obesity), or

    - 27 kg/m to < 30 kg/m (overweight) in the presence of at least one weight-related comorbidity e. g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.

    5 Pharmacology and Biochemistry
    5.1 FDA Pharmacological Classification
    5.1.1 Pharmacological Classes
    Glucagon-Like Peptide 1 [CS]; Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]; GLP-1 Receptor Agonist [EPC]
    5.2 ATC Code

    A10BJ06

    A10BJ06

    A10BJ06

    A - Alimentary tract and metabolism

    A10 - Drugs used in diabetes

    A10B - Blood glucose lowering drugs, excl. insulins

    A10BJ - Glucagon-like peptide-1 (glp-1) analogues

    A10BJ06 - Semaglutide

    API Reference Price

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ROAD,","city":"MUMBAI,MAHARASHTRA","supplier":"SHENZHEN JYMED TECHNOLOGY","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"0.06","actualQuantity":"60","unit":"GMS","unitRateFc":"200","totalValueFC":"12121.2","currency":"USD","unitRateINR":"17420","date":"25-Jan-2025","totalValueINR":"1045200","totalValueInUsd":"12121.2","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"7995641","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"RM. 806-810, 1#8\/F BIOMEDICINE INNO VATION INDUSTRIAL PARK, NO.14 JINHU I RD, PINGSHAN DIST, SHENZHEN GD Sh","customerAddress":"159, C.S.T. 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    27-Mar-2021
    31-Mar-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - SOLUTION;SUBCUTANEOUS - 2MG/3ML (0.6...DOSAGE - SOLUTION;SUBCUTANEOUS - 2MG/3ML (0.68MG/ML)

    USFDA APPLICATION NUMBER - 209637

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    DOSAGE - SOLUTION;SUBCUTANEOUS - 2MG/1.5ML (1...DOSAGE - SOLUTION;SUBCUTANEOUS - 2MG/1.5ML (1.34MG/ML)

    USFDA APPLICATION NUMBER - 209637

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    DOSAGE - SOLUTION;SUBCUTANEOUS - 4MG/3ML (1.3...DOSAGE - SOLUTION;SUBCUTANEOUS - 4MG/3ML (1.34MG/ML)

    USFDA APPLICATION NUMBER - 209637

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    DOSAGE - SOLUTION;SUBCUTANEOUS - 8MG/3ML (2.6...DOSAGE - SOLUTION;SUBCUTANEOUS - 8MG/3ML (2.68MG/ML)

    USFDA APPLICATION NUMBER - 209637

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    ABOUT THIS PAGE

    Looking for 910463-68-2 / Semaglutide API manufacturers, exporters & distributors?

    Semaglutide manufacturers, exporters & distributors 1

    59

    PharmaCompass offers a list of Semaglutide 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 Semaglutide manufacturer or Semaglutide supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Semaglutide manufacturer or Semaglutide supplier.

    PharmaCompass also assists you with knowing the Semaglutide API Price utilized in the formulation of products. Semaglutide API Price is not always fixed or binding as the Semaglutide Price is obtained through a variety of data sources. The Semaglutide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Semaglutide

    Synonyms

    Nn9535, Ozempic, Rybelsus, 910463-68-2, Nn 9535, Nnc 0113-0217

    Cas Number

    910463-68-2

    Semaglutide [USAN:INN] Manufacturers

    A Semaglutide [USAN:INN] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Semaglutide [USAN:INN], including repackagers and relabelers. The FDA regulates Semaglutide [USAN:INN] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Semaglutide [USAN:INN] 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 Semaglutide [USAN:INN] manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Semaglutide [USAN:INN] Suppliers

    A Semaglutide [USAN:INN] supplier is an individual or a company that provides Semaglutide [USAN:INN] active pharmaceutical ingredient (API) or Semaglutide [USAN:INN] finished formulations upon request. The Semaglutide [USAN:INN] suppliers may include Semaglutide [USAN:INN] API manufacturers, exporters, distributors and traders.

    click here to find a list of Semaglutide [USAN:INN] suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Semaglutide [USAN:INN] USDMF

    A Semaglutide [USAN:INN] DMF (Drug Master File) is a document detailing the whole manufacturing process of Semaglutide [USAN:INN] active pharmaceutical ingredient (API) in detail. Different forms of Semaglutide [USAN:INN] DMFs exist exist since differing nations have different regulations, such as Semaglutide [USAN:INN] USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Semaglutide [USAN:INN] DMF submitted to regulatory agencies in the US is known as a USDMF. Semaglutide [USAN:INN] USDMF includes data on Semaglutide [USAN:INN]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Semaglutide [USAN:INN] USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Semaglutide [USAN:INN] suppliers with USDMF on PharmaCompass.

    Semaglutide [USAN:INN] KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Semaglutide [USAN:INN] Drug Master File in Korea (Semaglutide [USAN:INN] KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Semaglutide [USAN:INN]. The MFDS reviews the Semaglutide [USAN:INN] KDMF as part of the drug registration process and uses the information provided in the Semaglutide [USAN:INN] KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Semaglutide [USAN:INN] 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 Semaglutide [USAN:INN] API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Semaglutide [USAN:INN] suppliers with KDMF on PharmaCompass.

    Semaglutide [USAN:INN] 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 Semaglutide [USAN:INN] as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Semaglutide [USAN:INN] 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 Semaglutide [USAN:INN] 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 Semaglutide [USAN:INN] and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Semaglutide [USAN:INN] NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Semaglutide [USAN:INN] suppliers with NDC on PharmaCompass.

    Semaglutide [USAN:INN] GMP

    Semaglutide [USAN:INN] 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 Semaglutide [USAN:INN] 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 Semaglutide [USAN:INN] GMP manufacturer or Semaglutide [USAN:INN] GMP API supplier for your needs.

    Semaglutide [USAN:INN] CoA

    A Semaglutide [USAN:INN] CoA (Certificate of Analysis) is a formal document that attests to Semaglutide [USAN:INN]'s compliance with Semaglutide [USAN:INN] specifications and serves as a tool for batch-level quality control.

    Semaglutide [USAN:INN] CoA mostly includes findings from lab analyses of a specific batch. For each Semaglutide [USAN:INN] 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.

    Semaglutide [USAN:INN] may be tested according to a variety of international standards, such as European Pharmacopoeia (Semaglutide [USAN:INN] EP), Semaglutide [USAN:INN] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Semaglutide [USAN:INN] 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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