Suppliers and packagers for NUZYRA

NUZYRA

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Paratek Pharms	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817	NDA	Paratek Pharmaceuticals, Inc.	71715-001-02	10 VIAL, GLASS in 1 CARTON (71715-001-02) / 10 mL in 1 VIAL, GLASS (71715-001-01)	2019-02-01
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816	NDA	Paratek Pharmaceuticals, Inc.	71715-002-21	1 BLISTER PACK in 1 CARTON (71715-002-21) / 6 TABLET, FILM COATED in 1 BLISTER PACK (71715-002-28)	2019-02-01
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816	NDA	Paratek Pharmaceuticals, Inc.	71715-002-27	5 BLISTER PACK in 1 CARTON (71715-002-27) / 6 TABLET, FILM COATED in 1 BLISTER PACK (71715-002-28)	2019-02-01

Suppliers for the Pharmaceutical Drug: NUZYRA

Last updated: July 30, 2025

Introduction

NUZYRA (omadacycline) is an advanced, broad-spectrum antibiotic developed by Paratek Pharmaceuticals. Approved by the U.S. Food and Drug Administration (FDA) in October 2019, NUZYRA addresses indications such as community-acquired bacterial pneumonia (CABP), acute bacterial skin and skin structure infections (ABSSSI), and certain other infections. As a semi-synthetic tetracycline derivative, its manufacturing requires a complex supply chain involving multiple specialized suppliers for key raw materials, active pharmaceutical ingredients (APIs), and formulation components. This report examines the suppliers underpinning NUZYRA’s production, providing insights into the industry landscape, supply chain robustness, and strategic considerations critical for stakeholders.

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Supply Chain Overview for NUZYRA

The complexity of NUZYRA's manufacture stems from its chemical sophistication and stringent regulatory standards. Its supply chain encompasses raw material vendors, API manufacturers, formulation and fill-finish providers, and logistic partners. Given the proprietary nature of its synthesis pathway, pharma companies typically source critical intermediates and APIs from select qualified suppliers with proven compliance and quality assurance.

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Key Raw Material Suppliers

1. Active Pharmaceutical Ingredient (API) Suppliers

   The core of NUZYRA's supply chain involves sourcing (or manufacturing) the API: omadacycline. Paratek Pharmaceuticals initially developed its proprietary synthesis route through partnerships with specialized chemical manufacturers. Although exact supplier identities remain undisclosed, industry sources suggest the following trends:

   • Specialized Contract Manufacturing Organizations (CMOs): Paratek collaborated with CMOs possessing advanced capabilities in complex tetracycline derivative synthesis. Key players likely include firms within the United States and Asia with expertise in antibiotic manufacturing under Good Manufacturing Practices (GMP).

   • Raw Material Precursors: The synthesis requires specific chemical building blocks, including advanced heterocyclic compounds, which are procured from high-grade chemical suppliers globally. Manufacturers typically source these intermediates from global chemical suppliers with strict quality and regulatory adherence.

2. Intermediates and Specialty Chemicals

   Critical to the API synthesis are intermediates such as tetracycline derivatives, heterocycles, and solvents. Leading chemical suppliers like BASF, Sigma-Aldrich (Merck), and Dow Chemical may supply these materials for use in API production, though specifics remain proprietary.

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Formulation and Fill-Finish Suppliers

Once the API is produced, formulation factories combine it with excipients suited for oral tablet development. Contract fill-finish providers, such as Catalent, Vetter, or Dr. Reddy’s, are typically involved in filling and packaging NUZYRA. These firms are renowned for their high-quality standards in sterile and non-sterile manufacturing.

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Supply Chain Challenges and Mitigation Strategies

The complexity of antibiotic synthesis makes supply chain resilience a priority. Paratek's collaboration with diversified suppliers minimizes dependency on a single source. The COVID-19 pandemic revealed vulnerabilities in pharmaceutical supply chains, propelling companies to develop contingency plans, including dual sourcing and regional manufacturing capabilities.

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Regulatory and Quality Assurance

Suppliers must meet stringent regulatory standards, including FDA’s Current Good Manufacturing Practices (cGMP) and international equivalents. Due diligence processes such as supplier audits, quality agreements, and ongoing compliance monitoring are standard to ensure product integrity and stability.

Intellectual Property and Proprietary Knowledge

Paratek retains core synthesis patents and processes for omadacycline, confining supplier relationships primarily to licensed entities. These partnerships are often governed by licensing agreements, restricting third-party disclosures.

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Future Outlook and Strategic Considerations

As demand for NUZYRA grows, supply chain stakeholders must scale manufacturing capacity without compromising quality. The potential emergence of alternative synthesis routes and partnerships with new suppliers could enhance capacity and reduce risks. Moreover, international suppliers of specialized intermediates are increasing their capacities to meet global needs.

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Conclusion

The supplier landscape for NUZYRA involves a complex web of highly specialized chemical manufacturers, contract development and manufacturing organizations (CDMOs), and formulation providers. While specific supplier identities remain proprietary, industry trends indicate reliance on major chemical suppliers for intermediates and partnerships with global CMOs for manufacturing and packaging. Ensuring supply chain resilience involves diversified sourcing, rigorous quality standards, and strategic planning aligned with regulatory requirements.

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Key Takeaways

• NUZYRA’s supply chain is centered on the procurement of high-quality intermediates, API manufacturing by specialized CMOs, and formulation by established CDMOs.
• Key suppliers are likely global chemical companies and contract manufacturers with proven compliance and capacity.
• Supply chain resilience depends on diversification of suppliers and adherence to stringent quality standards amid ongoing manufacturing expansions.
• Intellectual property restrictions shape supplier relationships, favoring licensed partners with proprietary synthesis knowledge.
• Strategic collaborations and capacity investments are vital for meeting growing global demand for NUZYRA.

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FAQs

Q1: Are there multiple suppliers for NUZYRA’s API to prevent shortages?
A1: While specific supplier identities remain confidential, industry best practices involve multiple licensed manufacturing partners to mitigate risks of shortages and ensure regulatory compliance.

Q2: How does Paratek Pharmaceuticals ensure the quality of its chemical suppliers?
A2: The company conducts rigorous audits, quality assessments, and contractual quality agreements aligned with cGMP standards to ensure suppliers meet stringent quality and regulatory requirements.

Q3: What role do Asian chemical manufacturers play in NUZYRA’s supply chain?
A3: Asian chemical manufacturers are often involved in producing intermediates and specialty chemicals used in API synthesis due to their scale and expertise, though final manufacturing is typically conducted by licensed firms under strict quality controls.

Q4: Are there any recent innovations in the synthesis process that could affect suppliers?
A4: Advances in synthetic chemistry, including more efficient routes and greener processes, may alter supplier relationships and capacities. Paratek continues to innovate to optimize production and supply resilience.

Q5: How has COVID-19 impacted NUZYRA’s supply chain?
A5: The pandemic underscored supply chain vulnerabilities, prompting diversification of suppliers, increased inventories, and strategic stockpiling to ensure uninterrupted supply.

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References

1. U.S. Food and Drug Administration (FDA). "NUZYRA (Omadacycline) Prescribing Information." 2019.
2. Paratek Pharmaceuticals. "NUZYRA Development and Commercialization Detail." 2023.
3. Industry reports on pharmaceutical supply chain dynamics (e.g., IQVIA, EvaluatePharma).
4. Chemical supplier publications and company disclosures (e.g., BASF, Sigma-Aldrich).