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Dalbavancin

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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Rochem Dalbavancin

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 6 USDMF, 4 NDC API, 17 Listed Suppliers, $ API Reference Price

23 API Suppliers
6 USDMF
4 NDC API
17 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

3 FDF Dossiers, 1 FDA Orange Book, 2 Europe

3 FDF Dossiers
1 FDA Orange Book
2 Europe

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 12 SPI Pharma, 2 Faran Shimi Pharmaceutical, 3 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 BASF, 2 DFE Pharma, 2 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 16 Kerry, 4 Microlex e.U, 2 Pluviaendo, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 3 Sigachi Industries

relatedExcipients
1 Rochem International Inc
12 SPI Pharma
2 Faran Shimi Pharmaceutical
3 Gangwal Healthcare
1 Nanjing Well Pharmaceutical
1 Pfanstiehl
1 BASF
2 DFE Pharma
2 Gangwal Chemicals
1 Ingredion Pharma Solutions
16 Kerry
4 Microlex e.U
2 Pluviaendo
3 Roquette
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
3 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

37 Fillers, Diluents & Binders, 16 Direct Compression, 10 Chewable & Orodispersible Aids, 9 Taste Masking, 8 Co-Processed Excipients, 7 Granulation, 5 Parenteral, 3 Disintegrants & Superdisintegrants, 1 API Stability Enhancers, 1 Thickeners and Stabilizers

excipientsByApplications
37 Fillers, Diluents & Binders
16 Direct Compression
10 Chewable & Orodispersible Aids
9 Taste Masking
8 Co-Processed Excipients
7 Granulation
5 Parenteral
3 Disintegrants & Superdisintegrants
1 API Stability Enhancers
1 Thickeners and Stabilizers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 11 NEWS #PharmaBuzz

media
3 DATA COMPILATION #PharmaFlow
11 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 1 Finished Drug Prices, 4 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
1 Finished Drug Prices
4 Annual Reports

MARKET PLACE

8 APIs, 1 FDF Dossiers

marketPlace
8 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

1 US Patents, 3 US Exclusivities

patents
1 US Patents
3 US Exclusivities

REF. STANDARDS & IMPURITIES

1 Others

otherSolutions
1 Others

Dalbavancin

Synopsis

ACTIVE PHARMA INGREDIENTS

23

API Suppliers

6

USDMF

0

CEP/COS

CEP/COS Certifications

0

JDMF

0

EU WC

0

KDMF

4

NDC API

0

VMF

17

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 128,762

MARKET PLACE

8

API

1

FDF

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

3

FDF Dossiers

1

FDA Orange Book

FDA (Orange Book)

2

Europe

0

Canada

0

Australia

0

South Africa

0

Listed Dossiers

2DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

1

Others

PATENTS & EXCLUSIVITIES

1

US Patents

3

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

3

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

11

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

10,515,065

Annual Reports (USD Million)

241

Finished Drug Prices

56 RELATED EXCIPIENT COMPANIES

97EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Dalbavancin (hydrochloride), Ver 001, Ver-001, Dalbavancin hcl, Chembl3301650, Dalbavancin hydrochloride (5:8)

Molecular Formula

C₈₈H₁₀₁Cl₃N₁₀O₂₈

Molecular Weight

1853.1 g/mol

InChI Key

PEXPCJWLNBNBNT-AXKGEONOSA-N

Dalbavancin

1 2D Structure

Dalbavancin

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(2S,3S,4R,5R,6S)-6-[[(1S,2R,19R,22R,34S,37R,40R,52S)-5,32-dichloro-52-[3-(dimethylamino)propylcarbamoyl]-2,26,31,44,49-pentahydroxy-22-(methylamino)-21,35,38,54,56,59-hexaoxo-47-[(2R,3S,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-7,13,28-trioxa-20,36,39,53,55,58-hexazaundecacyclo[38.14.2.23,6.214,17.219,34.18,12.123,27.129,33.141,45.010,37.046,51]hexahexaconta-3,5,8,10,12(64),14(63),15,17(62),23(61),24,26,29(60),30,32,41(57),42,44,46(51),47,49,65-henicosaen-64-yl]oxy]-3,4-dihydroxy-5-(10-methylundecanoylamino)oxane-2-carboxylic acid;hydrochloride

2.1.2 InChI

InChI=1S/C88H100Cl2N10O28.ClH/c1-38(2)13-10-8-6-7-9-11-14-61(106)94-70-73(109)75(111)78(86(120)121)128-87(70)127-77-58-31-43-32-59(77)124-55-24-19-42(29-50(55)89)71(107)69-85(119)98-67(80(114)92-25-12-26-100(4)5)48-33-44(102)34-57(125-88-76(112)74(110)72(108)60(37-101)126-88)62(48)47-28-40(17-22-52(47)103)65(82(116)99-69)95-83(117)66(43)96-84(118)68-49-35-46(36-54(105)63(49)90)123-56-30-41(18-23-53(56)104)64(91-3)81(115)93-51(79(113)97-68)27-39-15-20-45(122-58)21-16-39;/h15-24,28-36,38,51,60,64-76,78,87-88,91,101-105,107-112H,6-14,25-27,37H2,1-5H3,(H,92,114)(H,93,115)(H,94,106)(H,95,117)(H,96,118)(H,97,113)(H,98,119)(H,99,116)(H,120,121);1H/t51-,60-,64-,65-,66-,67+,68+,69+,70-,71-,72-,73-,74+,75+,76+,78+,87-,88+;/m1./s1

2.1.3 InChI Key

PEXPCJWLNBNBNT-AXKGEONOSA-N

2.1.4 Canonical SMILES

CC(C)CCCCCCCCC(=O)NC1C(C(C(OC1OC2=C3C=C4C=C2OC5=C(C=C(C=C5)C(C6C(=O)NC(C7=C(C(=CC(=C7)O)OC8C(C(C(C(O8)CO)O)O)O)C9=C(C=CC(=C9)C(C(=O)N6)NC(=O)C4NC(=O)C1C2=C(C(=CC(=C2)OC2=C(C=CC(=C2)C(C(=O)NC(CC2=CC=C(O3)C=C2)C(=O)N1)NC)O)O)Cl)O)C(=O)NCCCN(C)C)O)Cl)C(=O)O)O)O.Cl

2.1.5 Isomeric SMILES

CC(C)CCCCCCCCC(=O)N[C@@H]1[C@H]([C@@H]([C@H](O[C@H]1OC2=C3C=C4C=C2OC5=C(C=C(C=C5)[C@H]([C@H]6C(=O)N[C@@H](C7=C(C(=CC(=C7)O)O[C@@H]8[C@H]([C@H]([C@@H]([C@H](O8)CO)O)O)O)C9=C(C=CC(=C9)[C@H](C(=O)N6)NC(=O)[C@@H]4NC(=O)[C@@H]1C2=C(C(=CC(=C2)OC2=C(C=CC(=C2)[C@H](C(=O)N[C@H](CC2=CC=C(O3)C=C2)C(=O)N1)NC)O)O)Cl)O)C(=O)NCCCN(C)C)O)Cl)C(=O)O)O)O.Cl

2.2 Synonyms

2.2.1 MeSH Synonyms

1. A-a-1 Antibiotic

2. Bi 397

3. Bi-397

4. Bi397

5. Dalbavancin

6. Dalvance

7. Mdl 64,397

8. Mdl-64397

9. Ver-001

10. Ver001

11. Xydalba

12. Zeven

2.2.2 Depositor-Supplied Synonyms

1. Dalbavancin (hydrochloride)

2. Ver 001

3. Ver-001

4. Dalbavancin Hcl

5. Chembl3301650

6. Dalbavancin Hydrochloride (5:8)

7. A-a 1

8. Cs-3579

9. Hy-17586

2.3 Create Date

2014-12-31

3 Chemical and Physical Properties

Molecular Formula	C₈₈H₁₀₁Cl₃N₁₀O₂₈
Molecular Weight	1853.1 g/mol
Hydrogen Bond Donor Count	22
Hydrogen Bond Acceptor Count	30
Rotatable Bond Count	22
Exact Mass	1850.585236 g/mol
Monoisotopic Mass	1850.585236 g/mol
Topological Polar Surface Area	573 Å²
Heavy Atom Count	129
Formal Charge	0
Complexity	3740
Isotope Atom Count	0
Defined Atom Stereocenter Count	18
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Indication

Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

5.2 ATC Code

J01XA04

API SUPPLIERS

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USDMF

01

Brightgene Bio-medical Technology Co...

China

Cosmoprof India

Not Confirmed

02

Brightgene Bio-medical Technology Co...

China

Cosmoprof India

Not Confirmed

03

Brightgene Bio-medical Technology Co...

China

Cosmoprof India

Not Confirmed

04

Brightgene Bio-medical Technology Co...

China

Cosmoprof India

Not Confirmed

05

Livzon Group Fuzhou Fuxing Pharmaceu...

China

Cosmoprof India

Not Confirmed

06

Xellia Pharmaceuticals Aps

Denmark

Cosmoprof India

Not Confirmed

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NDC API

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Listed Suppliers

01

Transo-Pharm USA LLC

U.S.A

Cosmoprof India

Not Confirmed

TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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U.S.A

Digital Content

Dalbavancin

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.

Transo Pharm USA Company Banner

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Digital Content

02

Rochem International Inc

U.S.A

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Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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U.S.A

Digital Content

Dalbavancin

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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03

Transo-Pharm Handels GmbH

Germany

Cosmoprof India

Not Confirmed

Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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Germany

Digital Content

Dalbavancin Hydrochloride

About the Company : Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its c...

Founded in 1987, Transo-Pharm is a fully licensed and certified global distributor of pharmaceutical components for the health and veterinary industries. The company supports its customers throughout the complete lifecycle of APIs, from product development to market research, sourcing, import-export and sales. Transo-Pharm offers a diverse range of products. It qualifies manufacturers for full compliance and serves both as a valuable sourcing agent for its clients and a regulatory marketing agent for API manufacturers. It has offices in Shanghai, Hong Kong, Singapore, the United States, and an affiliated office in Mumbai.

Transo Pharm Handels GmbH

Product Web Link

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04

Comhony Biotech

China

CPHI Middle east

Comhony Biotech manufactures fermentation & semi-synthetic APIs which aim at dermatology, anti-biotics; mitochondria & memory health.

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China

Digital Content

Dalbavancin

About the Company : Comhony Biotech is dedicated to supplying APIs and nutraceutical ingredients to worldwide clients in the pharmaceutical and nutraceutical sectors. Leveraging its proprietary techno...

Comhony Biotech is dedicated to supplying APIs and nutraceutical ingredients to worldwide clients in the pharmaceutical and nutraceutical sectors. Leveraging its proprietary technologies, Comhony produces fermentation and semi-synthetic products targeting dermatology and antibiotics (APIs), as well as mitochondria and memory health (nutraceuticals). Comhony's manufacturing facility has received approval and confirmation from the NMPA (CFDA) for its compliance with Chinese GMP standards, which is equivalent to EU, WHO, and ICH/Q7 GMP standards.

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05

Shanghai Minbiotech

China

Cosmoprof India

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Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

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China

Digital Content

Dalbavancin Hydrochloride

About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...

Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry.

Shanghai Minbiotech CB

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06

Chunghwa Chemical Synthesis & Biote...

Taiwan

Cosmoprof India

Not Confirmed

Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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Taiwan

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Dalbavancin

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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07

Omgene Life Sciences Pvt. Ltd

India

Cosmoprof India

Not Confirmed

Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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India

Digital Content

Dalbavancin

About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...

Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines.

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08

Aurobindo Pharma Limited

India

Cosmoprof India

Not Confirmed

09

Sumar Biotech

India

Cosmoprof India

Not Confirmed

10

Yacht Bio-Technology

China

Cosmoprof India

Not Confirmed

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API Reference Price

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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

AbbVie Inc

U.S.A

DDL Conference

Not Confirmed

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Lead Product(s) : Dalbavancin

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

DALVANCE FDA Approval Acute Bacterial Skin Structure Infections in Pediatric

Details : The 5 patients in the age group birth to less than 3 months of age were not included in the efficacy analyses since they were enrolled with expanded inclusion criteria and only received the single-dose DALVANCE regimen.

Brand Name : Dalvance

Molecule Type : Peptide

Upfront Cash : Not Applicable

July 23, 2021

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02

National Institutes of Health

U.S.A

DDL Conference

Not Confirmed

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