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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.


NDC API

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Finorga

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OMADACYCLINE TOSYLATE

NDC Package Code : 62009-1914

Start Marketing Date : 2018-10-02

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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CARBOGEN AMCIS AG

Switzerland
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CARBOGEN AMCIS AG

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OMADACYCLINE TOSYLATE

NDC Package Code : 58567-107

Start Marketing Date : 2023-02-15

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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OMADACYCLINE TOSYLATE

NDC Package Code : 46097-900

Start Marketing Date : 2023-08-01

End Marketing Date : 2025-12-31

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Marketing Category : BULK INGREDIENT

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OMADACYCLINE

NDC Package Code : 68225-111

Start Marketing Date : 2019-02-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (100mg/5mL)

Marketing Category : DRUG FOR FURTHER PROCESSING

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LSNE, Inc

U.S.A
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LSNE, Inc

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OMADACYCLINE

NDC Package Code : 73301-016

Start Marketing Date : 2024-10-16

End Marketing Date : 2026-12-31

Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (100mg/5mL)

Marketing Category : DRUG FOR FURTHER PROCESSING

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Omadacycline

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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Omadacycline Tosylate

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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Omadacycline

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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Omadacycline Tosylate

About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. It was founded by emerging entrepreneurs and a team of young yet ex...

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Omadacycline

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...

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 and their intermediates, electronic chemical materials and intermediates, large-scale production, sales and services, and provide customized synthetic services according to customer requirements. Sjar-Tech locates in Beijing Economic and Technological Development Zone, has its own R&D and development laboratory. Sjar-Tech has set up a R&D team with rich experience and strong technical strength, most of the practitioners have more than ten years' experience.
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Omadacycline

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...

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 generic APIs and FDFs with primary strategic focus on the regulated market. We have an exciting and very promising innovative pipeline including immuno-oncological therapeutic agents, orally available GLP-1RA peptides for type 2 diabetes, antibody drug conjugates for solid tumor, novel non-antibody dependent tumor targeting conjugates for brain cancer and solid tumor brain-metastasis.
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Lewens Labs

India
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Lewens Labs

India
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Omadacycline

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...

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, We worked on cost reduction of “Aceclofenac” which fetched us four national awards including one from Consultancy Development Center, Government of India. At Lewens, We aim to develop and provide quality,cost effective and sustainable solutions to our Customers by empowering people to think beyond the traditional norms of Chemistry and Engineering to come up with different and innovative solutions to the problems.
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About the Company : Haorui, established in 1997, is a manufacturer and supplier of APIs, intermediates, veterinary and food additives. Meanwhile, it is assisting global pharmaceutical companies to get...

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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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Drugs in Development

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Details:

Under the terms of the collaboration, Novasep and Paratek will manufacture NUZYRA® (omadacycline), an FDA-approved tetracycline-class, once-daily oral and intravenous antibiotic for the treatment of adults with CABP and acute bacterial skin and skin structure infections.


Lead Product(s): Omadacycline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Nuzyra

Study Phase: Approved FDFProduct Type: Antibiotic

Sponsor: Paratek Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration February 15, 2022

Axplora CB

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Axplora

Germany
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Lead Product(s) : Omadacycline

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Paratek Pharmaceuticals

Deal Size : Undisclosed

Deal Type : Collaboration

Details : Under the terms of the collaboration, Novasep and Paratek will manufacture NUZYRA® (omadacycline), an FDA-approved tetracycline-class, once-daily oral and intravenous antibiotic for the treatment of adults with CABP and acute bacterial skin and skin str...

Product Name : Nuzyra

Product Type : Antibiotic

Upfront Cash : Undisclosed

February 15, 2022

Axplora CB

Details:

Nuzyra (omadacycline) is a USFDA approved novel antibiotic, being investigated in adults with Nontuberculous Mycobacterial pulmonary disease caused by Mycobacterium abscessus complex.


Lead Product(s): Omadacycline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Nuzyra

Study Phase: Phase IIProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 14, 2024

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STLE Annual Meeting
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Details : Nuzyra (omadacycline) is a USFDA approved novel antibiotic, being investigated in adults with Nontuberculous Mycobacterial pulmonary disease caused by Mycobacterium abscessus complex.

Product Name : Nuzyra

Product Type : Antibiotic

Upfront Cash : Inapplicable

November 14, 2024

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Details:

Nuzyra (omadacycline) is a USFDA approved novel antibiotic, being investigated in adults with Nontuberculous Mycobacterial pulmonary disease caused by Mycobacterium abscessus complex.


Lead Product(s): Omadacycline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Nuzyra

Study Phase: Phase IIProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 11, 2024

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03

STLE Annual Meeting
Not Confirmed
STLE Annual Meeting
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Details : Nuzyra (omadacycline) is a USFDA approved novel antibiotic, being investigated in adults with Nontuberculous Mycobacterial pulmonary disease caused by Mycobacterium abscessus complex.

Product Name : Nuzyra

Product Type : Antibiotic

Upfront Cash : Inapplicable

August 11, 2024

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Details:

Nuzyra (omadacycline) is a USFDA approved novel antibiotic for the treatment of community-acquired bacterial pneumonia.


Lead Product(s): Omadacycline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Nuzyra

Study Phase: PreclinicalProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 31, 2024

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STLE Annual Meeting
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Details : Nuzyra (omadacycline) is a USFDA approved novel antibiotic for the treatment of community-acquired bacterial pneumonia.

Product Name : Nuzyra

Product Type : Antibiotic

Upfront Cash : Inapplicable

July 31, 2024

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Details:

Nuzyra (omadacycline tosylate) is a USFDA approved novel antibiotic for the treatment of community-acquired bacterial pneumonia.


Lead Product(s): Omadacycline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Nuzyra

Study Phase: Phase IVProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 18, 2024

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05

STLE Annual Meeting
Not Confirmed
STLE Annual Meeting
Not Confirmed

Details : Nuzyra (omadacycline tosylate) is a USFDA approved novel antibiotic for the treatment of community-acquired bacterial pneumonia.

Product Name : Nuzyra

Product Type : Antibiotic

Upfront Cash : Inapplicable

July 18, 2024

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Details:

Nuzyra (omadacycline) is a USFDA approved novel antibiotic for community-acquired bacterial pneumonia. Now it is being evaluated for post-exposure prophylaxis of inhalational anthrax.


Lead Product(s): Omadacycline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Nuzyra

Study Phase: PreclinicalProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 03, 2024

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06

STLE Annual Meeting
Not Confirmed
STLE Annual Meeting
Not Confirmed

Details : Nuzyra (omadacycline) is a USFDA approved novel antibiotic for community-acquired bacterial pneumonia. Now it is being evaluated for post-exposure prophylaxis of inhalational anthrax.

Product Name : Nuzyra

Product Type : Antibiotic

Upfront Cash : Inapplicable

May 03, 2024

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Details:

The agreement aims to support the development of omadacycline for post-exposure prophylaxis and pulmonary anthrax and the US-based commercial manufacturing of Nuzyra, a novel once-daily antibiotic approved for the treatment of community-acquired bacterial pneumonia and ABSSSI.


Lead Product(s): Omadacycline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Nuzyra

Study Phase: Phase IProduct Type: Antibiotic

Sponsor: BARDA

Deal Size: $304.0 million Upfront Cash: Undisclosed

Deal Type: Agreement October 07, 2023

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07

STLE Annual Meeting
Not Confirmed
STLE Annual Meeting
Not Confirmed

Details : The agreement aims to support the development of omadacycline for post-exposure prophylaxis and pulmonary anthrax and the US-based commercial manufacturing of Nuzyra, a novel once-daily antibiotic approved for the treatment of community-acquired bacteria...

Product Name : Nuzyra

Product Type : Antibiotic

Upfront Cash : Undisclosed

October 07, 2023

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Details:

The proceeds from the acquisition will advance the commercialization of Nuzyra (omadacycline), a tetracycline antibiotic, indicated for the treatment of adult patients with community-acquired bacterial pneumonia, and support the development of additional therapies.


Lead Product(s): Omadacycline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Nuzyra

Study Phase: PreclinicalProduct Type: Antibiotic

Sponsor: Gurnet Point Capital

Deal Size: $462.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition September 21, 2023

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08

STLE Annual Meeting
Not Confirmed
STLE Annual Meeting
Not Confirmed

Details : The proceeds from the acquisition will advance the commercialization of Nuzyra (omadacycline), a tetracycline antibiotic, indicated for the treatment of adult patients with community-acquired bacterial pneumonia, and support the development of additional...

Product Name : Nuzyra

Product Type : Antibiotic

Upfront Cash : Undisclosed

September 21, 2023

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Details:

Nuzyra (omadacycline tosylate) is a novel antibiotic which binds to the 30S ribosomal subunit and blocks protein synthesis and is available for the treatment of of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.


Lead Product(s): Omadacycline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Nuzyra

Study Phase: Phase IIProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 27, 2023

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09

STLE Annual Meeting
Not Confirmed
STLE Annual Meeting
Not Confirmed

Details : Nuzyra (omadacycline tosylate) is a novel antibiotic which binds to the 30S ribosomal subunit and blocks protein synthesis and is available for the treatment of of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infecti...

Product Name : Nuzyra

Product Type : Antibiotic

Upfront Cash : Inapplicable

June 27, 2023

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Details:

The proceeds from the acquisition will advance the commercialization of Nuzyra (omadacycline), a tetracycline antibiotic, indicated for the treatment of adult patients with community-acquired bacterial pneumonia, and support the development of additional therapies.


Lead Product(s): Omadacycline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Nuzyra

Study Phase: Approved FDFProduct Type: Antibiotic

Sponsor: Gurnet Point Capital

Deal Size: $287.0 million Upfront Cash: Undisclosed

Deal Type: Acquisition June 06, 2023

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10

STLE Annual Meeting
Not Confirmed
STLE Annual Meeting
Not Confirmed

Details : The proceeds from the acquisition will advance the commercialization of Nuzyra (omadacycline), a tetracycline antibiotic, indicated for the treatment of adult patients with community-acquired bacterial pneumonia, and support the development of additional...

Product Name : Nuzyra

Product Type : Antibiotic

Upfront Cash : Undisclosed

June 06, 2023

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FDF Dossiers

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OMADACYCLINE TOSYLATE

Brand Name : NUZYRA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Packaging :

Approval Date : 2018-10-02

Application Number : 209816

Regulatory Info : RX

Registration Country : USA

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OMADACYCLINE TOSYLATE

Brand Name : NUZYRA

Dosage Form : POWDER;INTRAVENOUS

Dosage Strength : EQ 100MG BASE/VIAL

Packaging :

Approval Date : 2018-10-02

Application Number : 209817

Regulatory Info : RX

Registration Country : USA

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FDA Orange Book

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OMADACYCLINE TOSYLATE

Brand Name : NUZYRA

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2018-10-02

Application Number : 209816

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Not Confirmed

OMADACYCLINE TOSYLATE

Brand Name : NUZYRA

Dosage Form : POWDER;INTRAVENOUS

Dosage Strength : EQ 100MG BASE/VIAL

Approval Date : 2018-10-02

Application Number : 209817

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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DATA COMPILATION #PharmaFlow

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DMF filings surge 44% in Q1 2025; India tops list with 51% rise in year-on-year submissions
The first quarter (Q1) of 2025 witnessed an impressive surge in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA), signaling a robust expansion in pharmaceutical development activities, the looming threat of tariffs notwithstanding.A total of 339 Type II DMFs were submitted during this period, as opposed to 235 submissions in Q1 2024, marking an exceptional increase of 44.26 percent. PharmaCompass’ data suggests that this is a record high for any first quarter.Overall, 440 DMFs were submitted across all categories (Types II, III, IV, and V) during Q1 2025, compared to 353 in the same period last year — representing a 24.65 percent increase.India and China continued to dominate the DMF landscape. India led with 162 submissions in Q1 2025, posting a remarkable 51.4 percent increase over 107 submissions recorded in Q1 2024. China followed with 135 submissions, representing a 33.66 percent increase over the 101 filings in Q1 2024.Taiwan sprung a surprise as a distant third. It made 12 DMF submissions in Q1 2025, as opposed to just one in Q1 2024. Western countries like the US, Spain, Germany, and Italy have maintained relatively stable or declining submission rates. Only the Netherlands showed significant growth with four DMF submissions in Q1 2025, up from zero in Q1 2024. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available)Indian giants MSN, Aurobindo, Cipla, Dr Reddy’s lead record-breaking DMF surgeIndia lived up to its “pharmacy of the world” reputation with the highest DMF submissions. In fact, seven of the top eight companies in the DMF tally were headquartered in India. MSN Group, emerged as the unequivocal leader with 23 submissions in Q1 2025, as against 15 in Q1 2024. Aurobindo Pharma increased its DMF activity from seven submissions in Q1 2024 to 12 in Q1 2025. Alivus Life Sciences, formerly known as Glenmark, made a dramatic leap with eight submissions in Q1 2025, quadrupling its previous year’s count of just two. Cipla more than doubled its DMF submissions — from three in Q1 2024 to eight in Q1 2025.Dr. Reddy’s Laboratories, one of India’s largest generic drugmakers, filed seven DMF submissions. The company’s Q1 2025 DMF portfolio includes high-value molecules like deucravacitinib, finerenone, enzalutamide, niraparib tosylate monohydrate, tucatinib, and tizanidine hydrochloride.Dr. Reddy’s has also indicated that they are open to manufacturing in the US. Meanwhile, Hetero Drugs filed seven submissions while Lee Pharma recorded six in Q1 2025.Chinese manufacturer Jiangsu East-Mab Biomedical Technology also established a significant presence with six DMFs. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Semaglutide, finerenone see most DMF submissions; first-time filings surge 64%Semaglutide and finerenone emerged as the most documented molecules in Q1 2025, each garnering nine DMF submissions. Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist that has revolutionized diabetes management and weight loss treatment, continues to attract significant manufacturer interest. Similarly, finerenone, a non-steroidal drug used in treating chronic kidney disease in type 2 diabetes patients, has garnered attention from manufacturers.Carfilzomib, used in multiple myeloma treatment, secured the third position with five DMF submissions. Deucravacitinib, a novel drug approved for moderate to severe plaque psoriasis, followed with four DMF submissions.There were several molecules with three DMF submissions each. Among them were tapinarof, a novel drug for psoriasis, and tirzepatide, a GLP-1/GIP receptor agonist that has shown remarkable efficacy in diabetes and weight management. During the quarter, 23 molecules received their inaugural DMF submissions. This number has risen by 64 percent since Q1 2024, when only 14 drugs saw their first DMF filings.In Q1 2025, these 23 first-time molecules collectively garnered 30 DMF submissions, with deucravacitinib emerging as the clear leader. Indian companies Dr. Reddy’s Laboratories and Cipla filed DMFs for this plaque psoriasis treatment as did Spain’s Curia and PMC Global.The Q1 2025 roster of first-time DMF filings include retatrutide (another GLP-1 receptor agonist), sotagliflozin, setmelanotide acetate, daridorexant, nusinersen, zavegepant, belzutifan, elacestrant dihydrochloride, selumetinib sulfate, sotorasib, atogepant, omadacycline tosylate, osilodrostat phosphate, ensifentrine, landiolol hydrochloride, maralixibat chloride, maribavir, methyl olivetolate, diazoxide choline, sparsentan, thinnertide, and vismodegib. View FDA DMF Filings in Q1 2025 (Power BI Dashboard, Free Excel Available) Our viewGiven Trump’s rhetoric around tariffs on imported drugs, the record-breaking DMF submissions in Q1 2025 sent out a strong message that the global pharmaceutical industry is willing to take on the complex geopolitical situation with resilience and strategic foresight.On a different note, the rise in DMF filings also indicate increased workload for the FDA staff, as also more inspections by the agency. It seems like more ‘laid off’ FDA employees will be asked to return to work in the coming days.

Impressions: 865

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-surge-44-in-q1-2025-india-tops-list-with-51-rise-in-year-on-year-submissions

#PharmaFlow by PHARMACOMPASS
15 May 2025

NEWS #PharmaBuzz

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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 USDMF

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

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

click here to find a list of Omadacycline suppliers with USDMF 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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