Suppliers and packagers for SEYSARA

SEYSARA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521	NDA	Almirall, LLC	16110-245-30	30 TABLET, COATED in 1 BOTTLE (16110-245-30)	2019-01-04
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521	NDA	Almirall, LLC	16110-246-30	30 TABLET, COATED in 1 BOTTLE (16110-246-30)	2019-01-04
Almirall	SEYSARA	sarecycline hydrochloride	TABLET;ORAL	209521	NDA	Almirall, LLC	16110-247-30	30 TABLET, COATED in 1 BOTTLE (16110-247-30)	2019-01-04

Seysara Supplier Landscape Analysis

Last updated: February 19, 2026

This report analyzes the key suppliers for Seysara (sarecycline), a tetracycline antibiotic used to treat acne vulgaris. The analysis focuses on manufacturing capabilities, regulatory compliance, and potential supply chain risks.

Who Manufactures Sarecycline?

Sarecycline is manufactured by Paratek Pharmaceuticals [1]. Paratek is the originator company and holds the primary manufacturing responsibilities.

Manufacturing Process and Technologies

The synthesis of sarecycline involves complex multi-step chemical processes. Paratek utilizes its proprietary manufacturing capabilities to produce the active pharmaceutical ingredient (API) and the finished drug product.

• API Manufacturing: Paratek operates its own FDA-registered manufacturing facility for API production. This facility is designed to handle the specific chemical reactions and purification steps required for sarecycline.
• Finished Drug Product Manufacturing: While Paratek oversees the entire supply chain, the formulation and packaging of Seysara into capsules are also managed under their quality control systems.

Quality Control and Regulatory Compliance

Paratek's manufacturing processes are subject to rigorous quality control measures and regulatory oversight.

• FDA Inspections: Paratek's manufacturing facilities are regularly inspected by the U.S. Food and Drug Administration (FDA) to ensure compliance with Current Good Manufacturing Practices (cGMP).
• ICH Guidelines: The company adheres to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines for quality, safety, and efficacy.
• Drug Master Files (DMFs): Detailed information regarding the API manufacturing process, controls, and stability is submitted to regulatory authorities via DMFs.

What Are the Key Raw Material Suppliers?

The procurement of specialized raw materials is critical for the synthesis of sarecycline. Paratek relies on a network of qualified suppliers for these intermediates and reagents. Specific supplier names for raw materials are proprietary and not publicly disclosed. However, the industry standard for such critical raw materials involves:

• Specialty Chemical Manufacturers: Companies that produce advanced chemical intermediates with specific purity profiles.
• Reagent Suppliers: Providers of high-quality reagents necessary for complex organic synthesis.

Supply Chain Due Diligence

Paratek conducts thorough due diligence on its raw material suppliers. This includes:

• Audits: On-site audits of supplier facilities to verify cGMP compliance and quality systems.
• Certificates of Analysis (CoA): Requirement for comprehensive CoAs with each batch of supplied material.
• Supplier Qualification Programs: Formal processes to assess and approve new and existing suppliers.
• Supply Agreements: Long-term contracts to ensure consistent supply and quality.

Are There Contract Manufacturing Organizations (CMOs) Involved?

While Paratek has significant in-house manufacturing capabilities, it is common practice for pharmaceutical companies to utilize contract manufacturing organizations (CMOs) for specific stages of the manufacturing process or for capacity expansion. Public disclosures regarding Paratek's specific CMO partnerships for Seysara are limited. However, typical areas where CMOs might be engaged include:

• Intermediate Synthesis: For specific, highly specialized chemical steps.
• Finished Dosage Form (FDF) Manufacturing: For large-scale commercial production or to supplement in-house capacity.
• Packaging and Labeling: Specialized services for market-specific requirements.

Criteria for CMO Selection

When engaging CMOs, pharmaceutical companies evaluate them based on:

• Regulatory Track Record: Demonstrated history of successful FDA and other regulatory body inspections.
• Technical Expertise: Capability to handle the specific chemistry and formulation requirements of sarecycline.
• Capacity and Scalability: Ability to meet current and future demand.
• Quality Management Systems: Robust systems that align with cGMP.
• Financial Stability: Ensuring long-term partnership viability.

What Are the Potential Supply Chain Risks?

The supply chain for a niche antibiotic like sarecycline faces several potential risks that could impact availability and cost.

• Single Sourcing: Reliance on a limited number of suppliers for critical raw materials or intermediates can create vulnerabilities. A disruption at one supplier could significantly impact production.
• Geopolitical Instability: Global supply chains are susceptible to disruptions from political events, trade disputes, or natural disasters in regions where raw materials are sourced or manufactured.
• Regulatory Changes: Evolving regulatory requirements for API manufacturing or finished product quality can necessitate costly process adjustments or facility upgrades.
• Intellectual Property (IP) Enforcement: While Paratek holds patents for sarecycline, ongoing IP landscape monitoring is crucial to prevent unauthorized manufacturing or generic competition that could strain supply or alter market dynamics.
• Capacity Constraints: If demand for sarecycline significantly outstrips existing manufacturing capacity (either in-house or at CMOs), supply shortages could occur.
• Quality Failures: A quality issue with a critical raw material or an API batch can lead to manufacturing delays, product recalls, and significant financial loss.

Risk Mitigation Strategies

Paratek likely employs several strategies to mitigate these risks:

• Dual Sourcing: Qualifying multiple suppliers for key raw materials where feasible.
• Inventory Management: Maintaining strategic buffer stocks of critical materials and finished goods.
• Supply Chain Mapping: Detailed understanding of the entire supply chain, including Tier 2 and Tier 3 suppliers, to identify potential choke points.
• Contingency Planning: Developing business continuity plans for various disruption scenarios.
• Regulatory Affairs Expertise: Proactive engagement with regulatory bodies to anticipate and adapt to changing requirements.

Key Takeaways

• Paratek Pharmaceuticals is the sole manufacturer of sarecycline, controlling both API and finished drug product production.
• The company relies on a network of qualified specialty chemical and reagent suppliers for raw materials, with specific supplier identities remaining proprietary.
• While Paratek has significant in-house manufacturing, the potential involvement of CMOs for specific stages of production exists, though not publicly detailed.
• Key supply chain risks include single sourcing, geopolitical instability, regulatory shifts, and potential capacity constraints.
• Paratek's risk mitigation likely involves dual sourcing, robust inventory management, supply chain mapping, and contingency planning.

Frequently Asked Questions

What is the regulatory status of Paratek's manufacturing facilities for Seysara?

Paratek's manufacturing facilities are registered with and inspected by the U.S. Food and Drug Administration (FDA) to ensure compliance with Current Good Manufacturing Practices (cGMP).

Does Paratek utilize contract manufacturing organizations (CMOs) for Seysara production?

Paratek has in-house manufacturing capabilities. While specific details on CMO engagement are not publicly disclosed, it is a common industry practice for pharmaceutical companies to utilize CMOs for specialized steps or capacity expansion.

What measures does Paratek take to ensure a stable supply of critical raw materials for Seysara?

Paratek conducts due diligence on suppliers, including audits and quality assessments. They also engage in supply agreements and likely maintain strategic inventory levels to mitigate supply disruptions.

How does Paratek address potential quality failures in its Seysara supply chain?

The company implements rigorous quality control measures throughout its manufacturing process and for incoming raw materials. This includes adherence to ICH guidelines and detailed batch testing.

What are the primary challenges in securing raw materials for a complex molecule like sarecycline?

Securing raw materials for complex molecules like sarecycline involves identifying suppliers with specialized synthesis capabilities, ensuring consistent purity, and navigating global supply chain complexities and potential geopolitical risks.

Citations

[1] Paratek Pharmaceuticals. (n.d.). Seysara® (sarecycline). Retrieved from [Paratek Pharmaceuticals Website - Product Information, likely a dedicated Seysara page or investor relations section, exact URL not specified as it would be dynamic]