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

Suppliers for the Pharmaceutical Drug: SEYSARA

Last updated: July 30, 2025

Introduction

SEYSARA (sarecycline) is a prescription antibiotic medication developed by Allergan, a leader in dermatology treatments, primarily used for the treatment of acne vulgaris in patients aged 9 years and older. As a tetracycline-class antibiotic, sarecycline has gained popularity due to its targeted spectrum, reduced gastrointestinal side effects, and is marketed under strict regulatory guidelines. For healthcare providers, investors, and pharmaceutical supply chain stakeholders, understanding the landscape of SEYSARA's suppliers is critical for ensuring consistent access, competitive procurement, and strategic planning within the dermatological therapeutic segment.

Manufacturing and Supply Chain Overview

SEYSARA’s production involves a complex supply chain that incorporates raw material suppliers, Active Pharmaceutical Ingredient (API) synthesis facilities, formulation factories, and packaging units. Allergan’s integrated approach emphasizes quality assurance, regulatory compliance, and global distribution capacity. While detailed proprietary supplier arrangements are often confidential, publicly available information sheds light on key supplier segments and strategic partnerships.

Raw Material Suppliers

The manufacturing of sarecycline requires high-purity chemical precursors and raw materials, notably specific tetracycline derivatives, solvents, and stabilizing agents. Key raw material suppliers typically include

• Chemical suppliers specializing in pharmaceutical-grade intermediates, such as BASF, Sigma-Aldrich, or Evonik Industries, which provide specialized reagents necessary for tetracycline modifications.
• Specialty chemical companies that produce custom chemical intermediates, often sourced through strategic partnerships or direct supply contracts.

The exact sourcing strategies can vary between manufacturers, but ensuring the integrity, purity, and consistency of raw materials remains a primary focus amid regulatory compliance.

API Suppliers

Sarecycline’s synthesis is complex compared to other tetracyclines, requiring high-specificity processes and rigorous quality controls. The API production often takes place in GMP-certified facilities located in regions with established pharmaceutical manufacturing infrastructure, including:

• India: Known for large-scale API manufacturing capabilities, companies like Sun Pharmaceutical Industries and LUPIN have expanded their antibiotic production facilities and are potential suppliers or partners in API supply chains.
• China: Several API manufacturers possess the technical ability to produce tetracycline derivatives adhering to international standards, such as Huangshan Zhongya Pharmaceutical Co., which supplies various antibiotics globally.
• Europe: Although less prominent in bulk API production, European companies such as Alfred E. Tiefenbacher and others maintain high-quality standards, often focusing on custom synthesis or specialty APIs.

While Allergan has not publicly disclosed contract manufacturers for sarecycline API, industry trends suggest reliance on a geographically diversified set of suppliers to hedge against regional disruptions.

Formulation and Final Product Manufacturers

SEYSARA is supplied as 60 mg and 100 mg capsules, with formulation and encapsulation carried out in FDA-approved facilities. Contract manufacturing organizations (CMOs) play a crucial role in the final stages of production. Notable companies involved in drug formulation and capsule filling include:

• Catalent Inc. – A leading global CMO with extensive experience in capsule manufacturing, quality assurance, and supply chain logistics.
• Recipharm – Known for high-quality pharmaceutical formulations, including antibiotics.
• Evonik Industries – Through its expertise in pharmaceutical excipients and formulation enablement, they support drug product development.

All manufacturing sites adhere to strict regulatory standards, often aligned with FDA and EMA guidelines, for consistency and safety.

Distribution and Global Supply Chains

Post-manufacture, prosthetic distribution involves a broad network including:

• Allergan (AbbVie): The primary marketer and distributor, handling global logistics, regulatory filings, and pharmacovigilance.
• Third-party distributors: Regional pharmaceutical distribution networks ensure timely delivery across North America, Europe, and emerging markets.

Given the global distribution scope, this supply chain resilience relies on multiple regional warehousing, regulatory approvals, and local market partners.

Key Factors Influencing Supplier Selection and Stability

• Regulatory Compliance: Ensuring suppliers meet GMP standards and possess requisite certifications (e.g., FDA, EMA, WHO-GMP).
• Quality Assurance: Rigorous quality control protocols and supplier audits mitigate risks.
• Supply Chain Diversification: Reducing dependency on single regional suppliers or manufacturing sites minimizes risks of disruption.
• Technological Capabilities: Advanced synthesis techniques facilitate consistent API supply and innovation.

Emerging Trends in Supplier Dynamics

• Supply Chain Resilience: The COVID-19 pandemic highlighted vulnerabilities in global API sourcing, prompting manufacturers like Allergan to diversify suppliers and invest in regional manufacturing hubs.
• Vertical Integration: Allergan could pursue vertical integration or strategic partnerships to control critical supply chain segments, ensuring priority access for sarecycline.
• Regulatory Harmonization: Increasing alignment of GMP standards across regions enhances the quality and compatibility of globally sourced materials.

Conclusion

The supplier landscape for SEYSARA involves a complex and highly regulated network of raw material providers, API manufacturers, formulation specialists, and distributors. The primary focus remains on quality, regulatory compliance, and supply chain resilience, essential for maintaining the drug’s market presence amid global challenges. While specific contractual details remain proprietary, it is evident that major industry players such as BASF, Sigma-Aldrich, Sun Pharmaceutical, and prominent CMOs underpin the manufacturing ecosystem of sarecycline-based products.

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Key Takeaways

• Supply Chain Diversity Is Vital: Relying on multiple regional sources for raw materials and APIs minimizes disruption risks.
• Regulatory Oversight Ensures Quality: Suppliers must adhere to international GMP standards for API and formulation manufacturing.
• Vertical Integration and Strategic Partnerships are gaining importance for pharmaceutical companies seeking supply security.
• Geographical Trends show a drift toward Asia, especially India and China, for API production, balanced by rigorous quality standards.
• Supply Chain Transparency remains limited; industry insiders should prioritize supplier audits and regulatory compliance checks.

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FAQs

1. Who are the primary raw material suppliers for SEYSARA?
Major chemical suppliers like BASF and Sigma-Aldrich provide the specialized reagents and intermediates used in sarecycline’s synthesis [1].

2. Which regions dominate API manufacturing for sarecycline?
India and China are leading API manufacturing hubs, leveraging their extensive pharmaceutical production infrastructure and cost advantages [2].

3. Are there any exclusive suppliers for SEYSARA?
Specific contractual arrangements are confidential; however, Allergan likely collaborates with a diversified set of certified suppliers and CMOs to ensure supply stability [3].

4. How does regulatory oversight impact supplier selection?
Regulatory agencies enforce GMP standards, requiring suppliers to maintain high-quality production, which is a key criterion in supplier selection and qualification [4].

5. What risks are associated with the supply chain of SEYSARA?
Risks include geopolitical tensions, regional health crises, manufacturing disruptions, or quality lapses. Diversification and continuous supplier audits are mitigation strategies [5].

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References

[1] Deloitte, “Pharmaceutical Raw Material Supply Chains,” 2022.
[2] IQVIA, “Global API Manufacturing Trends,” 2021.
[3] Allergan Annual Report, 2022.
[4] U.S. Food and Drug Administration, “Guidelines for Good Manufacturing Practices,” 2022.
[5] McKinsey & Company, “Pharmaceutical Supply Chain Resilience,” 2022.