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Synopsis

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Chemistry

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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 SUPPLIERS

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Bachem AG

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Supriya Lifescience

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Chunghwa Chemical Synthesis & Biot...

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Rochem International Inc

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ChemWerth Inc

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Transo-Pharm USA LLC

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LGM Pharma

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Inabata France S.A.S

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Faran Shimi Pharmaceutical

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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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Chongqing Sintaho Pharmaceutical

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Bachem Ag

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DMF Review : Complete

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DMF Number : 37594

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Ambiopharm Inc

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Polypeptide Sa

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Polypeptide Sa

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Bachem AG

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SEMAGLUTIDE

NDC Package Code : 55463-0040

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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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SEMAGLUTIDE

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Nomida

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Ningbo Kunpeng Biotech Co., Ltd.

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SEMAGLUTIDE

NDC Package Code : 84649-000

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Bachem AG

Switzerland
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Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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Semaglutide

About the Company : With more than 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology comp...

With more than 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide, providing a wide range of services. Over the years, Bachem has established itself as a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. The company is headquartered in Switzerland and has offices in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.
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Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

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Semaglutide

About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...

Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Supriya follows industry standards and constantly improves to deliver quality products. Its facility is 47,000 square meters with dedicated areas for warehouse, QA, QC, R&D, production and finished products. The current capacity is 550 KL, with plans to expand to over 1000 KL by 2024. Supriya has 14 active USDMFs, 8 active CEPs, strong R&D and compliant facilities worldwide. Supriya works with innovators, generic companies, and as a CMO.
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Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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Semaglutide

About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...

Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast Asia to receive FDA approval for synthetic and biotech APIs, CCSB has a proven track record of commercializing Statin, Immunosuppressant, Muscle Relaxant, and ACE Inhibitor APIs, all with complete DMF or COS. For years, CCSB has partnered with leading brand and generic drug companies to develop and produce APIs and advanced intermediates, focusing on specialty APIs crafted through a sophisticated fusion of fermentation and synthesis technologies in Taiwan.
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Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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Semaglutide

About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.
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Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Semaglutide

About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...

Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs to regulated markets worldwide and has exclusive partnerships for new product development, compliance support and secure supply chain logistics. ChemWerth has access to over 500 APIs and more than 30 manufacturing facilities in the US, Europe, India and China. ChemWerth acts as a regulatory agent for over 25 FDA-approved facilities and sells more than 100 products. It has established its presence in 38 countries. In 2020, ChemWerth filed its 500th DMF with the FDA.
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Virtual BoothTransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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Semaglutide

About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...

Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout the entire API life cycle, from product development through sales. Transo-Pharm serves as a sourcing and regulatory marketing agent for API manufacturers. It aids clients in establishing DMFs and provides GMP consulting. With a dedicated regulatory department, a warehouse, proprietary IPs for API processes, and partnerships with laboratories, Transo-Pharm offers a wide range of services. It operates from its offices in Shanghai, Hong Kong, Singapore, and the US.
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LGM Pharma

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Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Semaglutide

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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Virtual BoothIKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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Semaglutide

About the Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata...

Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata-Pharmasynthèse offers a wide range of services, including sourcing, manufacturing, and the development of raw materials for the pharmaceutical and cosmetic industries. It supplies these ingredients to Europe, Japan, and other countries. With expertise in fine chemical production, Inabata-Pharmasynthèse conducts manufacturing operations, ranging from pilot to commercial quantities, at its GMP-certified facility at St. Pierre-Les-Elbeuf in France.
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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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Semaglutide

About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.
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Virtual BoothChongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.

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Semaglutide

About the Company : Sintaho Pharmaceutical Co., Ltd., located in Chongqing, China, contributes to being the most dependable partner for global pharmaceutical companies. Sintaho specializes in chemosyn...

Sintaho Pharmaceutical Co., Ltd., located in Chongqing, China, contributes to being the most dependable partner for global pharmaceutical companies. Sintaho specializes in chemosynthetic APIs (application contains oncology, nervous system, and metabolic diseases and etc.,) with a product portfolio ranging from small molecule APIs, ADC compounds (linkers and payloads) to polypeptides, also provides CDMO services of cytotoxic and OEB4/5 grade APIs.
Chongqing Sintaho Pharmaceutical
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27-Feb-2021
30-Dec-2024
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

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Drugs in Development

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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.


Lead Product(s): Semaglutide

Therapeutic Area: Nutrition and Weight Loss Brand Name: Semaglutide-Generic

Study Phase: Phase IIIProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 19, 2023

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01

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

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

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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.


Lead Product(s): Semaglutide

Therapeutic Area: Nutrition and Weight Loss Brand Name: Semaglutide-Generic

Study Phase: Phase IIIProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 18, 2023

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02

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

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

Dr Reddy Company Banner

Details:

Wegovy (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to reduce the risk of non-fatal myocardial infarction in adults.


Lead Product(s): Semaglutide

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Wegovy

Study Phase: ApprovedProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 27, 2024

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03

Novo Nordisk

Denmark
arrow
BIO Partnering at JPM
Not Confirmed

Novo Nordisk

Denmark
arrow
BIO Partnering at JPM
Not Confirmed

Details : Wegovy (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to reduce the risk of non-fatal myocardial infarction in adults.

Brand Name : Wegovy

Molecule Type : Peptide

Upfront Cash : Not Applicable

November 27, 2024

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Details:

Wegovy (semaglutide) is a GLP-1 receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management & treatment of obesity.


Lead Product(s): Semaglutide

Therapeutic Area: Nutrition and Weight Loss Brand Name: Wegovy

Study Phase: ApprovedProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 18, 2024

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04

Novo Nordisk

Denmark
arrow
BIO Partnering at JPM
Not Confirmed

Novo Nordisk

Denmark
arrow
BIO Partnering at JPM
Not Confirmed

Details : Wegovy (semaglutide) is a GLP-1 receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management & treatment of obesity.

Brand Name : Wegovy

Molecule Type : Peptide

Upfront Cash : Not Applicable

November 18, 2024

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Details:

Wegovy (semaglutide) is a GLP-1 receptor agonist being investigated for the treatment of adults with obesity or overweight with established cardiovascular disease (CVD) and without diabetes.


Lead Product(s): Semaglutide

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Wegovy

Study Phase: Phase IIIProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 03, 2024

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05

Novo Nordisk

Denmark
arrow
BIO Partnering at JPM
Not Confirmed

Novo Nordisk

Denmark
arrow
BIO Partnering at JPM
Not Confirmed

Details : Wegovy (semaglutide) is a GLP-1 receptor agonist being investigated for the treatment of adults with obesity or overweight with established cardiovascular disease (CVD) and without diabetes.

Brand Name : Wegovy

Molecule Type : Peptide

Upfront Cash : Not Applicable

November 03, 2024

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Details:

Wegovy (semaglutide) is a GLP-1 receptor agonist being investigated for the treatment of adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis.


Lead Product(s): Semaglutide

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Wegovy

Study Phase: Phase IIIProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 01, 2024

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06

Novo Nordisk

Denmark
arrow
BIO Partnering at JPM
Not Confirmed

Novo Nordisk

Denmark
arrow
BIO Partnering at JPM
Not Confirmed

Details : Wegovy (semaglutide) is a GLP-1 receptor agonist being investigated for the treatment of adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis.

Brand Name : Wegovy

Molecule Type : Peptide

Upfront Cash : Not Applicable

November 01, 2024

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Details:

Anti-CD3 antibody TZLS-401 (foralumab) in combination with semaglutide, a GLP-1 agonist is being investigated for obesity.


Lead Product(s): Foralumab,Semaglutide

Therapeutic Area: Nutrition and Weight Loss Brand Name: TZLS-401

Study Phase: PreclinicalProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 30, 2024

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07

Tiziana Life Sciences

United Kingdom
arrow
BIO Partnering at JPM
Not Confirmed

Tiziana Life Sciences

United Kingdom
arrow
BIO Partnering at JPM
Not Confirmed

Details : Anti-CD3 antibody TZLS-401 (foralumab) in combination with semaglutide, a GLP-1 agonist is being investigated for obesity.

Brand Name : TZLS-401

Molecule Type : Large molecule

Upfront Cash : Not Applicable

October 30, 2024

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Details:

Oral DehydraTECH-technology processed semaglutide and liraglutide (GLP-1 agonist) is being investigated for obesity.


Lead Product(s): Liraglutide,Semaglutide

Therapeutic Area: Endocrinology Brand Name: DehydraTECH-liraglutide

Study Phase: PreclinicalProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 24, 2024

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08

BIO Partnering at JPM
Not Confirmed
BIO Partnering at JPM
Not Confirmed

Details : Oral DehydraTECH-technology processed semaglutide and liraglutide (GLP-1 agonist) is being investigated for obesity.

Brand Name : DehydraTECH-liraglutide

Molecule Type : Peptide

Upfront Cash : Not Applicable

October 24, 2024

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Details:

NG101 is an oral, peripherally restricted dopamine D2 receptor antagonist, being investigated for nausea and vomiting side effects caused by GLP-1 agonist medication.


Lead Product(s): Metopimazine Mesylate,Semaglutide

Therapeutic Area: Neurology Brand Name: NG101

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 16, 2024

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09

Neurogastrx

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Neurogastrx

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : NG101 is an oral, peripherally restricted dopamine D2 receptor antagonist, being investigated for nausea and vomiting side effects caused by GLP-1 agonist medication.

Brand Name : NG101

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 16, 2024

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Details:

Semaglutide is a peptide GLP-1 agonist, peptide drug candidate, which is being evaluated for the treatment of type 2 diabetes & obesity.


Lead Product(s): Semaglutide

Therapeutic Area: Endocrinology Brand Name: Undisclosed

Study Phase: PreclinicalProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 21, 2024

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10

ProLynx

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

ProLynx

U.S.A
arrow
BIO Partnering at JPM
Not Confirmed

Details : Semaglutide is a peptide GLP-1 agonist, peptide drug candidate, which is being evaluated for the treatment of type 2 diabetes & obesity.

Brand Name : Undisclosed

Molecule Type : Peptide

Upfront Cash : Not Applicable

August 21, 2024

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Europe

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01

BIO Partnering at JPM
Not Confirmed
arrow
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BIO Partnering at JPM
Not Confirmed

Semaglutide

Brand Name : Ozempic DualDose

Dosage Form : Inj L?s

Dosage Strength : 2mg/1.5ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Semaglutide

Brand Name : Ozempic FixDose

Dosage Form : Inj L?s

Dosage Strength : 4mg/3ml(1mg/dose)

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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03

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Semaglutide

Brand Name : Rybelsus

Dosage Form : Tabl

Dosage Strength : 14mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

04

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Semaglutide

Brand Name : Rybelsus

Dosage Form : Tabl

Dosage Strength : 14mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

05

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Semaglutide

Brand Name : Rybelsus

Dosage Form : Tabl

Dosage Strength : 3mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

06

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Semaglutide

Brand Name : Rybelsus

Dosage Form : Tablet

Dosage Strength : 7mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

07

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Semaglutide

Brand Name : Rybelsus

Dosage Form : Tablet

Dosage Strength : 7mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

08

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Semaglutide

Brand Name : Wegovy

Dosage Form : Multi Fixdose Inj Solution

Dosage Strength : 0.5mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

09

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Semaglutide

Brand Name : Wegovy

Dosage Form : Multi Fixdose Inj Solution

Dosage Strength : 1.7mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

10

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Semaglutide

Brand Name : Wegovy

Dosage Form : Multi Fixdose Inj Solution

Dosage Strength : 1mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Canada

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01

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET

Dosage Strength : 3MG

Packaging : 30

Approval Date :

Application Number : 2497581

Regulatory Info :

Registration Country : Canada

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02

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET

Dosage Strength : 7MG

Packaging : 30

Approval Date :

Application Number : 2497603

Regulatory Info :

Registration Country : Canada

blank

03

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

SEMAGLUTIDE

Brand Name : RYBELSUS

Dosage Form : TABLET

Dosage Strength : 14MG

Packaging : 30

Approval Date :

Application Number : 2497611

Regulatory Info :

Registration Country : Canada

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04

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

SEMAGLUTIDE

Brand Name : OZEMPIC

Dosage Form : SOLUTION

Dosage Strength : 1.34MG/ML

Packaging : 2 X2MG/PEN

Approval Date :

Application Number : 2471469

Regulatory Info :

Registration Country : Canada

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05

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

SEMAGLUTIDE

Brand Name : OZEMPIC

Dosage Form : SOLUTION

Dosage Strength : 1.34MG/ML

Packaging : 1X 2MG/PEN

Approval Date :

Application Number : 2471477

Regulatory Info :

Registration Country : Canada

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06

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

SEMAGLUTIDE

Brand Name : OZEMPIC

Dosage Form : SOLUTION

Dosage Strength : 0.68MG/ML

Packaging :

Approval Date :

Application Number : 2540258

Regulatory Info :

Registration Country : Canada

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07

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

SEMAGLUTIDE

Brand Name : WEGOVY

Dosage Form : SOLUTION

Dosage Strength : 2MG/1.5ML

Packaging :

Approval Date :

Application Number : 2528517

Regulatory Info :

Registration Country : Canada

blank

08

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

SEMAGLUTIDE

Brand Name : WEGOVY

Dosage Form : SOLUTION

Dosage Strength : 4MG/3ML

Packaging :

Approval Date :

Application Number : 2528525

Regulatory Info :

Registration Country : Canada

blank

09

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

SEMAGLUTIDE

Brand Name : WEGOVY

Dosage Form : SOLUTION

Dosage Strength : 6.8MG/3ML

Packaging :

Approval Date :

Application Number : 2528533

Regulatory Info :

Registration Country : Canada

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10

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

SEMAGLUTIDE

Brand Name : WEGOVY

Dosage Form : SOLUTION

Dosage Strength : 9.6MG/3ML

Packaging :

Approval Date :

Application Number : 2528541

Regulatory Info :

Registration Country : Canada

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Australia

read-more
read-more

01

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

semaglutide

Brand Name : Ozempic

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank

02

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

semaglutide

Brand Name : Ozempic

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank

03

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

semaglutide

Brand Name : Ozempic

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

blank

04

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

semaglutide

Brand Name : Ozempic

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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South Africa

read-more
read-more

01

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Semaglutide

Brand Name : Ozempic

Dosage Form : PED

Dosage Strength : 1.34mg/ml

Packaging : 1.5X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

BIO Partnering at JPM
Not Confirmed
arrow
arrow
BIO Partnering at JPM
Not Confirmed

Semaglutide

Brand Name : Ozempic

Dosage Form : PED

Dosage Strength : 1.34mg/ml

Packaging : 3X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Listed Dossiers

read-more
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01

arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Semaglutide

Brand Name :

Dosage Form : Subcutaneous Pen

Dosage Strength : 0.25MG/0.5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

01

arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Semaglutide

Dosage : Subcutaneous Pen

Dosage Strength : 0.25MG/0.5ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Supriya

02

arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Semaglutide

Brand Name :

Dosage Form : Subcutaneous Pen

Dosage Strength : 0.5MG/0.5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

02

arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Semaglutide

Dosage : Subcutaneous Pen

Dosage Strength : 0.5MG/0.5ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Supriya

03

arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Semaglutide

Brand Name :

Dosage Form : Subcutaneous Pen

Dosage Strength : 1MG/0.5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

03

arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Semaglutide

Dosage : Subcutaneous Pen

Dosage Strength : 1MG/0.5ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Supriya

04

arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Semaglutide

Brand Name :

Dosage Form : Subcutaneous Pen

Dosage Strength : 1.7MG/0.75ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

04

arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Semaglutide

Dosage : Subcutaneous Pen

Dosage Strength : 1.7MG/0.75ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Supriya

05

arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Semaglutide

Brand Name :

Dosage Form : Subcutaneous Pen

Dosage Strength : 2.4MG/0.75ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

05

arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Semaglutide

Dosage : Subcutaneous Pen

Dosage Strength : 2.4MG/0.75ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Supriya

06

arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Regulatory Info :

Registration Country : India

Semaglutide

Brand Name :

Dosage Form : Tablet

Dosage Strength : 14MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Supriya

06

arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSupriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info :

Semaglutide

Dosage : Tablet

Dosage Strength : 14MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

Supriya

07

Pharmathen SA

Greece
arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Regulatory Info : USA

Registration Country : Greece

Semaglutide

Brand Name :

Dosage Form : Tablet

Dosage Strength : 3MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

07

Pharmathen SA

Greece
arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Packaging :

Regulatory Info : USA

Semaglutide

Dosage : Tablet

Dosage Strength : 3MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Greece

Pharmathen

08

Pharmathen SA

Greece
arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Regulatory Info : USA

Registration Country : Greece

Semaglutide

Brand Name :

Dosage Form : Tablet

Dosage Strength : 14MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

08

Pharmathen SA

Greece
arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Packaging :

Regulatory Info : USA

Semaglutide

Dosage : Tablet

Dosage Strength : 14MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Greece

Pharmathen

09

Pharmathen SA

Greece
arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Regulatory Info : USA

Registration Country : Greece

Semaglutide

Brand Name :

Dosage Form : Injection For Subcutan...

Dosage Strength : 2MG/1.5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info : USA

Registration Country : Greece

Pharmathen

09

Pharmathen SA

Greece
arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Packaging :

Regulatory Info : USA

Semaglutide

Dosage : Injection For Subcutan...

Dosage Strength : 2MG/1.5ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Greece

Pharmathen

10

Pharmathen SA

Greece
arrow
BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

Flag Greece
Digital Content Digital Content

Regulatory Info :

Registration Country : Greece

Semaglutide

Brand Name :

Dosage Form : Solution For Injection

Dosage Strength : 2MG/1.5ML

Packaging : Pre-filled Pen

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Greece

Pharmathen

10

Pharmathen SA

Greece
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  • fda
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  • WHO-GMP

Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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Packaging : Pre-filled Pen

Regulatory Info :

Semaglutide

Dosage : Solution For Injection

Dosage Strength : 2MG/1.5ML

Brand Name :

Approval Date :

Application Number :

Registration Country : Greece

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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

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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