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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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26-Mar-2021
29-Mar-2025
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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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Semaglutide manufacturers, exporters & distributors 1

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API | Excipient name

Semaglutide

Synonyms

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

Cas Number

910463-68-2

Semaglutide Manufacturers

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

Semaglutide Suppliers

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

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

Semaglutide USDMF

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

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

click here to find a list of Semaglutide suppliers with USDMF on PharmaCompass.

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

After submitting a Semaglutide 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 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Semaglutide suppliers with KDMF on PharmaCompass.

Semaglutide 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Semaglutide suppliers with NDC on PharmaCompass.

Semaglutide GMP

Semaglutide 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 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 GMP manufacturer or Semaglutide GMP API supplier for your needs.

Semaglutide CoA

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

Semaglutide CoA mostly includes findings from lab analyses of a specific batch. For each Semaglutide 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Semaglutide EP), Semaglutide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Semaglutide 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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