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1. Nuzyra
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)-
Molecular Weight | 556.6 g/mol |
---|---|
Molecular Formula | C29H40N4O7 |
XLogP3 | 3 |
Hydrogen Bond Donor Count | 6 |
Hydrogen Bond Acceptor Count | 10 |
Rotatable Bond Count | 7 |
Exact Mass | 556.28969963 g/mol |
Monoisotopic Mass | 556.28969963 g/mol |
Topological Polar Surface Area | 177 Ų |
Heavy Atom Count | 40 |
Formal Charge | 0 |
Complexity | 1140 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 4 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
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
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.
J - Antiinfectives for systemic use
J01 - Antibacterials for systemic use
J01A - Tetracyclines
J01AA - Tetracyclines
J01AA15 - Omadacycline
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.
Omadacycline is not known to be metabolized in humans.
Omadacycline has a mean half life of elimination of 16.2 h.
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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41641
Submission : 2025-03-26
Status : Active
Type : II
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
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
NDC Package Code : 46097-900
Start Marketing Date : 2023-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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
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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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
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
Novasep And Paratek Enhance Collaboration to Manufacture Omadacycline (NUZYRA®), A Novel Tetracyc...
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
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
Lead Product(s) : Omadacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Paratek Omadacycline Phase 2b Shows Promise in NTM Treatment
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
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
Lead Product(s) : Omadacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Paratek Announces Positive Data for Oral Omadacycline in NTM Disease
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
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
Lead Product(s) : Omadacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Paratek Completes Five-Year Study of NUZYRA® Showing No Change in In Vitro Potency
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
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
Lead Product(s) : Omadacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Paratek Pharmaceuticals Announces Top-line Data from NUZYRA® for Severe Pneumonia
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
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
Lead Product(s) : Omadacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Paratek Reports Positive Data for NUZYRA® As Anthrax Prophylaxis, Triggers BARDA
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
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
Lead Product(s) : Omadacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : BARDA
Deal Size : $304.0 million
Deal Type : Agreement
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
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
Lead Product(s) : Omadacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Gurnet Point Capital
Deal Size : $462.0 million
Deal Type : Acquisition
Gurnet Point Capital and Novo Holdings A/S Complete Acquisition of Paratek Pharmaceuticals, Inc.
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
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
Lead Product(s) : Omadacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
Lead Product(s) : Omadacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Gurnet Point Capital
Deal Size : $287.0 million
Deal Type : Acquisition
Paratek Pharmaceuticals to be Acquired by Gurnet Point Capital and Novo Holdings
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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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Patents & EXCLUSIVITIES
ABOUT THIS PAGE
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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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Omadacycline API and other APIs are published in this directory by the FDA.
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.
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 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.
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).