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Chemistry

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Also known as: Amadacycline, 389139-89-3, Nuzyra, Ptk 0796, Omadacycline [usan], Ptk-0796
Molecular Formula
C29H40N4O7
Molecular Weight
556.6  g/mol
InChI Key
VJYKVCURWJGLPG-IQZGDKDPSA-N
FDA UNII
090IP5RV8F

Omadacycline
Omadacycline has been used in trials studying the treatment of Bacterial Pneumonia, Bacterial Infections, Community-Acquired Infections, and Skin Structures and Soft Tissue Infections. Omadacycline represents a significant advance over the well-known tetracycline family, and has been shown to be highly effective in animal models at treating increasingly problematic, clinically prevalent infections caused by gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), and by gram-negative, atypical and anaerobic bacteria, including those resistant to currently available classes of antibiotics and known to cause diseases such as pneumonias, urinary tract infections, skin diseases and blood-borne infections in both the hospital and community settings.
Omadacycline is a Tetracycline-class Antibacterial.
1 2D Structure

Omadacycline

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4S,4aS,5aR,12aR)-4,7-bis(dimethylamino)-9-[(2,2-dimethylpropylamino)methyl]-1,10,11,12a-tetrahydroxy-3,12-dioxo-4a,5,5a,6-tetrahydro-4H-tetracene-2-carboxamide
2.1.2 InChI
InChI=1S/C29H40N4O7/c1-28(2,3)12-31-11-14-10-17(32(4)5)15-8-13-9-16-21(33(6)7)24(36)20(27(30)39)26(38)29(16,40)25(37)18(13)23(35)19(15)22(14)34/h10,13,16,21,31,34-35,38,40H,8-9,11-12H2,1-7H3,(H2,30,39)/t13-,16-,21-,29-/m0/s1
2.1.3 InChI Key
VJYKVCURWJGLPG-IQZGDKDPSA-N
2.1.4 Canonical SMILES
CC(C)(C)CNCC1=CC(=C2CC3CC4C(C(=O)C(=C(C4(C(=O)C3=C(C2=C1O)O)O)O)C(=O)N)N(C)C)N(C)C
2.1.5 Isomeric SMILES
CC(C)(C)CNCC1=CC(=C2C[C@H]3C[C@H]4[C@@H](C(=O)C(=C([C@]4(C(=O)C3=C(C2=C1O)O)O)O)C(=O)N)N(C)C)N(C)C
2.2 Other Identifiers
2.2.1 UNII
090IP5RV8F
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Nuzyra

2.3.2 Depositor-Supplied Synonyms

1. Amadacycline

2. 389139-89-3

3. Nuzyra

4. Ptk 0796

5. Omadacycline [usan]

6. Ptk-0796

7. Bay 73-6944

8. 090ip5rv8f

9. 389139-89-3 (free Base)

10. (4s,4as,5ar,12ar)-4,7-bis(dimethylamino)-9-[(2,2-dimethylpropylamino)methyl]-1,10,11,12a-tetrahydroxy-3,12-dioxo-4a,5,5a,6-tetrahydro-4h-tetracene-2-carboxamide

11. Omadacycline (usan)

12. (4s,4as,5ar,12as)-4,7-bis(dimethylamino)-9-(((2,2-dimethylpropyl)amino)methyl)- 3,10,12,12a- Tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2- Carboxamide

13. Amadacycline Methanesulfonate

14. Omadacycline [usan:inn]

15. Unii-090ip5rv8f

16. (4s,4as,5ar,12as)-4,7-bis(dimethylamino)-9-[(2,2-dimethylpropylamino)methyl]-3,10,12,12a-tetrahydroxy-1,11-dioxo-4a,5,5a,6-tetrahydro-4h-tetracene-2-carboxamide

17. 2-naphthacenecarboxamide, 4,7-bis(dimethylamino)-9-(((2,2-dimethylpropyl)amino)methyl)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, (4s,4as,5ar,12as)-

18. 2-naphthacenecarboxamide, 4,7-bis(dimethylamino)-9-[[(2,2-dimethylpropyl)amino]methyl]-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, (4s,4as,5ar,12as)-

19. Mk-2764

20. Omadacycline [mi]

21. Omadacycline [inn]

22. Omadacycline [who-dd]

23. Schembl1525961

24. 9-neopentylaminomethylminocycline

25. Chembl1689772

26. Schembl17150976

27. Schembl20952297

28. Gtpl10839

29. Ptk-796

30. Ptk0796

31. Chebi:177758

32. Dtxsid201027687

33. Bcp12946

34. Ex-a4252

35. Zinc4836283

36. Compound 6 [pmid: 21302930]

37. Cs-1338

38. Db12455

39. Bay-73-6944

40. Bay-73-7388

41. Ncgc00378946-03

42. Ac-33245

43. Hy-14865

44. Ptk 0796, Bay 73-6944

45. D09647

46. E80520

47. Q15426992

48. (4s,4as,5ar,12as)-4,7-bis(dimethylamino)-9-(((2,2-dimethylpropyl)amino)methyl)-3,10,12,12a- Tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide

49. 2-naphthacenecarboxamide, 4,7-bis(dimethylamino)-9-(((2,2- Dimethylpropyl)amino)methyl)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a- Tetrahydroxy-1,11-dioxo-, (4s,4as,5ar,12as)-

2.4 Create Date
2011-12-26
3 Chemical and Physical Properties
Molecular Weight 556.6 g/mol
Molecular Formula C29H40N4O7
XLogP33
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count10
Rotatable Bond Count7
Exact Mass556.28969963 g/mol
Monoisotopic Mass556.28969963 g/mol
Topological Polar Surface Area177 Ų
Heavy Atom Count40
Formal Charge0
Complexity1140
Isotope Atom Count0
Defined Atom Stereocenter Count4
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

Omadacycline is indicated for the treatment of community acquired bacterial pneumonia and acute bacterial skin and skin structure infections caused by omadacycline-susceptible organisms in adults.


FDA Label


Treatment of bacterial pneumonia


Treatment of acute bacterial skin and skin structure infections


5 Pharmacology and Biochemistry
5.1 Pharmacology

Omadacycline can be either bacteriostatic or bacteriocidal depending on the organism involved. It disrupts bacterial protein synthesis without affecting DNA, RNA, or peptidoglycan synthesis. Omadacycline represents an improvement over existing tetracycline agents as it has not been found to be subject to tetracycline resistance mediated by tetracycline efflux pumps encoded by the tet(K), tet(L), and tet(B) or to ribosomal protection proteins encoded by tet(O) and tet(M). Omadacycline is susceptible to RNA mutations which confer resistance to tetracyclines.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
OMADACYCLINE
5.2.2 FDA UNII
090IP5RV8F
5.2.3 Pharmacological Classes
Tetracyclines [CS]; Tetracycline-class Antibacterial [EPC]
5.3 ATC Code

J - Antiinfectives for systemic use

J01 - Antibacterials for systemic use

J01A - Tetracyclines

J01AA - Tetracyclines

J01AA15 - Omadacycline


5.4 Absorption, Distribution and Excretion

Absorption

Omadacycline has an mean absolute oral bioavailability of 34.5% and a mean Tmax of2.5 h with oral dosing. With multiple dosing, Omadacycline displays an accumulation factor of 1.5. Official labeling states that food does not significantly impact rate or extent of absorption, however, conflicting data exists suggesting food may lower the bioavailability of omadacycline taken after eating. The exposure in alveolar cells and epithelial lining fluid is 25.8 and 1.5 fold higher than plasma exposure after IV administration, suggesting Omadacycline penetrates the lungs to a significant degree.


Route of Elimination

After IV dosing 27% of Omadacycline was eliminated by the kidneys. In oral dosing 14.4% was found to be eliminated by the kidneys and 81.1% in the feces. Neither renal nor hepatic impairment appears to produce a clinically relevant effect elimination.


Volume of Distribution

Omadacycline has a mean Vd of 256 L after a single dose and a Vss of 190 L.


Clearance

Omadacycline has a mean systemic clearance of 11.24 L/h and a renal clearance of 2.4-3.3 L/h.


5.5 Metabolism/Metabolites

Omadacycline is not known to be metabolized in humans.


5.6 Biological Half-Life

Omadacycline has a mean half life of elimination of 16.2 h.


5.7 Mechanism of Action

Omadacycline binds to the primary tetracycline binding site on the bacterial 30s ribosomal subunit with high specificity. There it acts to block protein synthesis, disrupting many facets of cellular function and resulting in either cell death or stasis.


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Lewens Labs

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CARBOGEN AMCIS AG

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About the Company : Beijing Sjar Technology Development Co., Ltd. founded in 2014, it is a high-tech enterprise which specialized in the research and development of active pharmaceutical ingredients a...

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About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special gener...

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About the Company : Lewens Labs finds its roots in 4 years of engineering during which we saw a dream to carve out a niche for ourselves in Pharmaceutical Industry. As a part of the final year project...

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Omadacycline

About the Company : Zhejiang Huida Biotech Co., Ltd. is located in Hangzhou, Zhejiang Province. It was established in 2020 and is a holding subsidiary of Huadong Medicine Co., Ltd. The company focu...

Zhejiang Huida Biotech Co., Ltd. is located in Hangzhou, Zhejiang Province. It was established in 2020 and is a holding subsidiary of Huadong Medicine Co., Ltd. The company focuses on the research and development of microbial active pharmaceutical substances (APIs), intermediates and large health products. It is a technologically innovative fermentation product research enterprise. With strong R&D strength, the company provides first-class technology, first-class service and first-class products to global customers by discovering and cultivating the most valuable microbial metabolites.
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[{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1636655400,"product":"INTERMEDIATE OF OMADACYCLINE TOSYLATE (4S,4AS,5AR,12AR)-9-(AMINOMETHYL)-4,7-BIS(DIMETHYLAMINO)-1,10,11,12A-TETRAHYDROXY-","address":"SHOP-37, FIRST FLR. KAMLA BHAVAN I I,S. NITYANAND ROAD ANDHERI EAST","city":"MUMBAI,MAHARASHTRA","supplier":"REGEN BIOPHARMA","supplierCountry":"CHINA","foreign_port":"NA","customer":"GUFIC BIOSCIENCES","customerCountry":"INDIA","quantity":"2500.20","actualQuantity":"2500.2","unit":"GMS","unitRateFc":"24.8","totalValueFC":"62898.1","currency":"USD","unitRateINR":"1873.5","date":"12-Nov-2021","totalValueINR":"4684099.97","totalValueInUsd":"62898.1","indian_port":"MADRAS AIR","hs_no":"29413090","bill_no":"6229753","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SHOP-37, FIRST FLR. KAMLA BHAVAN I I,S. NITYANAND ROAD ANDHERI EAST"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1641321000,"product":"INTERMEDIATE OF OMADACYCLINE TOSYLATE (4S,4AS,5AR,12AR)-9-(AMINOMETHYL)-4,7-BIS(DIMETHYLAMINO)-1,10,11,12A-TETRAHYDROXY-","address":"SHOP-37, FIRST FLR. KAMLA BHAVAN I I,S. NITYANAND ROAD ANDHERI EAST","city":"MUMBAI,MAHARASHTRA","supplier":"REGEN BIOPHARMA","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GUFIC BIOSCIENCES","customerCountry":"INDIA","quantity":"3750.00","actualQuantity":"3750","unit":"GMS","unitRateFc":"24","totalValueFC":"93209.5","currency":"USD","unitRateINR":"1851.6","date":"05-Jan-2022","totalValueINR":"6943500","totalValueInUsd":"93209.5","indian_port":"MADRAS AIR","hs_no":"29413090","bill_no":"6960508","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"","customerAddress":"SHOP-37, FIRST FLR. KAMLA BHAVAN I I,S. NITYANAND ROAD ANDHERI EAST"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1663353000,"product":"INTERMEDIATE OF OMADACYCLINE TOSYLATE (4S,4AS,5AR,12AR)-9-(AMINOMETHYL)-4,7-BIS(DIMETHYLAMINO)-1,10,11,12A-TETRAHYDROXY-","address":"SHOP-37, FIRST FLR. KAMLA BHAVAN I I,S. NITYANAND ROAD ANDHERI EAST","city":"MUMBAI,MAHARASHTRA","supplier":"REGEN BIOPHARMA","supplierCountry":"CHINA","foreign_port":"NA","customer":"GUFIC BIOSCIENCES","customerCountry":"INDIA","quantity":"5000.00","actualQuantity":"5000","unit":"GMS","unitRateFc":"19.4","totalValueFC":"97313.4","currency":"USD","unitRateINR":"1559.8","date":"17-Sep-2022","totalValueINR":"7798800","totalValueInUsd":"97313.4","indian_port":"MADRAS AIR","hs_no":"29413090","bill_no":"2485457","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SHOP-37, FIRST FLR. KAMLA BHAVAN I I,S. NITYANAND ROAD ANDHERI EAST"}]
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17-Sep-2022
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ABOUT THIS PAGE

Looking for 389139-89-3 / Omadacycline API manufacturers, exporters & distributors?

Omadacycline manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Omadacycline API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Omadacycline manufacturer or Omadacycline supplier for your needs.

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

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

API | Excipient name

Omadacycline

Synonyms

Amadacycline, 389139-89-3, Nuzyra, Ptk 0796, Omadacycline [usan], Ptk-0796

Cas Number

389139-89-3

Unique Ingredient Identifier (UNII)

090IP5RV8F

About Omadacycline

Omadacycline has been used in trials studying the treatment of Bacterial Pneumonia, Bacterial Infections, Community-Acquired Infections, and Skin Structures and Soft Tissue Infections. Omadacycline represents a significant advance over the well-known tetracycline family, and has been shown to be highly effective in animal models at treating increasingly problematic, clinically prevalent infections caused by gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), and by gram-negative, atypical and anaerobic bacteria, including those resistant to currently available classes of antibiotics and known to cause diseases such as pneumonias, urinary tract infections, skin diseases and blood-borne infections in both the hospital and community settings.

Omadacycline Manufacturers

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

Omadacycline Suppliers

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

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

Omadacycline 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 Omadacycline as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Omadacycline GMP

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

Omadacycline CoA

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

Omadacycline CoA mostly includes findings from lab analyses of a specific batch. For each Omadacycline 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.

Omadacycline may be tested according to a variety of international standards, such as European Pharmacopoeia (Omadacycline EP), Omadacycline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Omadacycline 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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