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63 API Suppliers, 33 USDMF, 3 KDMF, 56 NDC API, 35 Listed Suppliers, $ API Reference Price

63 API Suppliers
33 USDMF
3 KDMF
56 NDC API
35 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

57 Drugs in Development

57 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

70 FDF Dossiers, 14 FDA Orange Book, 12 Europe, 11 Canada, 4 Australia, 2 South Africa, 27 Listed Dossiers

70 FDF Dossiers
14 FDA Orange Book
12 Europe
11 Canada
4 Australia
2 South Africa
27 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;SUBCUTANEOUS - 2MG/3ML (0.68MG/ML), SOLUTION;SUBCUTANEOUS - 2MG/1.5ML (1.34MG/ML), SOLUTION;SUBCUTANEOUS - 4MG/3ML (1.34MG/ML), SOLUTION;SUBCUTANEOUS - 8MG/3ML (2.68MG/ML)

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SOLUTION;SUBCUTANEOUS - 2MG/3ML (0.68MG/ML)
SOLUTION;SUBCUTANEOUS - 2MG/1.5ML (1.34MG/ML)
SOLUTION;SUBCUTANEOUS - 4MG/3ML (1.34MG/ML)
SOLUTION;SUBCUTANEOUS - 8MG/3ML (2.68MG/ML)

RELATED EXCIPIENT COMPANIES

1 Nanjing Well Pharmaceutical, 1 BASF, 1 Finar, 1 Valens Pharmachem

relatedExcipients
1 Nanjing Well Pharmaceutical
1 BASF
1 Finar
1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

3 Topical, 2 Film Formers & Plasticizers, 2 Solubilizers, 1 Emulsifying Agents, 1 Thickeners and Stabilizers, 1 Parenteral

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3 Topical
2 Film Formers & Plasticizers
2 Solubilizers
1 Emulsifying Agents
1 Thickeners and Stabilizers
1 Parenteral

DIGITAL CONTENT

10 DATA COMPILATION #PharmaFlow, 9 STOCK RECAP #PipelineProspector, 439 NEWS #PharmaBuzz

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10 DATA COMPILATION #PharmaFlow
9 STOCK RECAP #PipelineProspector
439 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 12 Finished Drug Prices, 13 Annual Reports

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1 US Medicaid Prescriptions
12 Finished Drug Prices
13 Annual Reports

MARKET PLACE

47 APIs, 5 FDF Dossiers

marketPlace
47 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

147 US Patents, 17 US Exclusivities

patents
147 US Patents
17 US Exclusivities

Bachem Semaglutide

Synopsis

ACTIVE PHARMA INGREDIENTS

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Europe

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DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

147

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

439

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

2,147,483,647

Annual Reports (USD Million)

44,049

Finished Drug Prices

10EXCIPIENTS BY APPLICATIONS

Chemistry

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Click the button for full data set

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

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 Formula	C₁₈₇H₂₉₁N₄₅O₅₉
Molecular Weight	4114 g/mol
XLogP3	-5.8
Hydrogen Bond Donor Count	57
Hydrogen Bond Acceptor Count	63
Rotatable Bond Count	151
Exact Mass	4112.1187318 g/mol
Monoisotopic Mass	4111.1153770 g/mol
Topological Polar Surface Area	1650 Å²
Heavy Atom Count	291
Formal Charge	0
Complexity	9590
Isotope Atom Count	0
Defined Atom Stereocenter Count	30
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

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

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 SUPPLIERS

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Switzerland

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API Reference Price

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LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"KWALITY PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.11","actualQuantity":"105","unit":"GMS","unitRateFc":"140","totalValueFC":"14870.3","currency":"USD","unitRateINR":"11879","date":"28-Aug-2024","totalValueINR":"1247295","totalValueInUsd":"14870.3","indian_port":"Delhi Air","hs_no":"29339990","bill_no":"5290374","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"ADD: ROOM2603,RONG TAI\\'AN BUILDINGNO.139 JINHUAI STREET,FENGZE ROADFENGZE DISTRICT QUANZHOU CITY FUJIA CHINA","customerAddress":"VILLAGE NAG KALAN,MAJITHA ROAD,MAJ"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726425000,"product":"SEMAGLUTIDE P29","address":"NO 31, RACE COURSE ROAD,BANGALORE","city":"BENGALURU,KARNATAKA","supplier":"HANGZHOU SAIMING PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"MICRO LABS LIMITED","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"0.02","unit":"KGS","unitRateFc":"74000","totalValueFC":"1499.4","currency":"USD","unitRateINR":"6282600","date":"16-Sep-2024","totalValueINR":"125652","totalValueInUsd":"1499.4","indian_port":"Madras Air","hs_no":"29371900","bill_no":"5632845","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"RM. 317, NO.268 DAGUAN ROAD, GONGSHU DISTRICT, HANGZHOU, ZHEJIANG, CHINA","customerAddress":"NO 31, RACE COURSE ROAD,BANGALORE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727634600,"product":"SEMAGLUTIDE (PARENTRAL GRADE)","address":"304,MOHAN PLACE,L.S.C.BLOCK-C","city":"DELHI","supplier":"SINOPEP ALLSINO BIOPHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AKUMS DRUGS & PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"500","totalValueFC":"50476.6","currency":"USD","unitRateINR":"42300","date":"30-Sep-2024","totalValueINR":"4230000","totalValueInUsd":"50476.6","indian_port":"Bombay Air","hs_no":"29379090","bill_no":"5882589","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.28 LINPU ROAD LIANYUNGANG INDUST RIAL AREA ECO AND TECH, DEVELOPMENT ZONE, 222000, JIANGSU CHINA China","customerAddress":"304,MOHAN PLACE,L.S.C.BLOCK-C"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729103400,"product":"(FOC)SEMAGLUTIDE (SINOPEP)(R & D PURPOSE)","address":"NO.138-B, UDAYAGIRI COMPLEX, KIADB","city":"BANGALORE","supplier":"PHARMATHEN SA","supplierCountry":"GREECE","foreign_port":"ATHENS","customer":"ONESOURCE SPECIALTY PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.87","actualQuantity":"870","unit":"GMS","unitRateFc":"834.7","totalValueFC":"814534.1","currency":"EUR","unitRateINR":"78669.5","date":"17-Oct-2024","totalValueINR":"68442493.28","totalValueInUsd":"814534.1","indian_port":"Bangalore Air","hs_no":"29371900","bill_no":"6169840","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"ATHENS","supplierAddress":"6, DERVENAKION STR., 15351 PALLII A TTIKIS GREECE, , Greece SDNF Greece","customerAddress":"NO.138-B, UDAYAGIRI COMPLEX, KIADB"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

01 Dr. Reddy's Laboratories

India

CPhI India 2024

Booth #RH.E02

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Lead Product(s) : Semaglutide

Therapeutic Area : Nutrition and Weight Loss

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

DEALS_DEV

Dr Reddy’s Labs Gets Nod to Study Popular Weight Loss Medication

Details : Semaglutide is a GLP-1 receptor agonist, which is being investigated in Phase 3 for the treatment of weight loss type 2 diabetes and chronic kidney disease.

Brand Name : Semaglutide-Generic

Molecule Type : Peptide

Upfront Cash : Not Applicable

October 19, 2023

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

Virtual Booth

02 Dr. Reddy's Laboratories

India

CPhI India 2024

Booth #RH.E02

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Lead Product(s) : Semaglutide

Therapeutic Area : Nutrition and Weight Loss

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

DEALS_DEV

Dr Reddy's Gears up for Weight Loss Drug Study

Details : subcutaneous semaglutide is a GLP-1 receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults.

Brand Name : Semaglutide-Generic

Molecule Type : Peptide

Upfront Cash : Not Applicable

October 18, 2023

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

Virtual Booth