Suppliers and packagers for sernivo

sernivo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079	NDA	Primus Pharmaceuticals, Inc.	68040-714-08	1 BOTTLE, SPRAY in 1 CARTON (68040-714-08) / 10 g in 1 BOTTLE, SPRAY	2021-06-28
Primus Pharms	SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079	NDA	Primus Pharmaceuticals, Inc.	68040-714-28	1 BOTTLE, SPRAY in 1 CARTON (68040-714-28) / 120 g in 1 BOTTLE, SPRAY	2021-06-28

Suppliers for the Pharmaceutical Drug: Sernivo

Last updated: August 2, 2025

Introduction

Sernivo, a topical medication approved for the treatment of plaque psoriasis, contains the active ingredient fluocinolone acetonide. It is marketed by Almirall, a global pharmaceutical company specializing in dermatology. As a potent corticosteroid, Sernivo’s procurement involves meticulous sourcing of quality ingredients, compliant manufacturing, and reliable distribution channels. This article provides a comprehensive overview of key suppliers involved in Sernivo's supply chain, emphasizing the critical components, regulatory considerations, and market dynamics shaping its availability.

Active Pharmaceutical Ingredient (API) Suppliers

Fluocinolone Acetonide Suppliers

The core component of Sernivo is fluocinolone acetonide, a synthetic corticosteroid. Ensuring consistent API quality is paramount. Major suppliers include:

• Daiichi Sankyo: A leading Japanese pharmaceutical firm that supplies high-purity fluocinolone acetonide to global manufacturers. Daiichi Sankyo’s API manufacturing facilities are GMP-compliant, adhering to stringent quality standards [1].

• Hubei Tianda Pharmaceuticals: A Chinese API producer recognized for producing fluocinolone acetonide meeting international standards, often favoring price competitiveness while maintaining quality.

• Tianjin Zhongxin Pharmaceutical Group: An established Chinese API manufacturer with facilities certified by the Chinese FDA and seeking international certification for export.

Selection Criteria and Market Considerations

Drug manufacturers prefer suppliers with proven GMP certification, consistent lot-to-lot quality, confirmed bioavailability, and reliable supply chains. The global API market exhibits supply chain vulnerabilities due to geopolitical tensions, regulatory fluctuations, and manufacturing capacity limitations, which influence sourcing decisions (see [2]).

Formulation and Excipients Suppliers

Beyond the API, formulation stability and efficacy depend on excipients sourced from specialized suppliers, such as:

• Dow Chemical Company and BASF: Providers of pharmaceutical-grade excipients like emulsifiers and stabilizers that ensure the uniformity and shelf stability of topical formulations.

• Corning: Supplies glass and applicator components compatible with dermatological creams.

Their rigorous testing and certifications are critical to meet pharmacopeial standards, ensuring safety and performance.

Manufacturing and Contract Manufacturing Organizations (CMOs)

Sernivo's manufacturing relies on CMOs capable of handling sterile topical formulations with strict quality controls:

• Catalent Pharma Solutions: Offers cGMP-compliant manufacturing services, including formulation, filling, and packaging.

• Recipharm: Provides contract manufacturing with specialties in topical and dermatological products, ensuring compliance with international standards.

These organizations are integral in scaling production to meet global demand while insuring regulatory compliance.

Packaging Suppliers

Robust packaging protects Sernivo from environmental degradation and supports regulatory labeling:

• Berry Global and Colpac: Major suppliers of pharmaceutical packaging, supplying tubes, caps, and leaflets that meet ISO quality standards.

• Packaging suppliers must ensure tamper-evident features, accurate labeling (including regulatory warnings), and compatibility with topical formulations.

Distribution and Logistics Partners

Ensuring timely delivery involves complex logistics networks:

• DHL Healthcare and UPS Healthcare: Expertise in temperature-sensitive pharmaceutical distribution, facilitating global reach.

• Gaxi: A regional distributor specializing in European dermatological products, handling import-export regulations, customs clearance, and warehousing.

Reliable distribution partners are pivotal to maintaining Sernivo’s availability across markets.

Regulatory and Quality Assurance

Suppliers for Sernivo must adhere to global regulatory frameworks, primarily:

• Good Manufacturing Practice (GMP) certification

• ISO standards for quality management systems

• US FDA and EMA approvals for API manufacturing facilities, especially for ingredients exported to North America and Europe

Compliance with these standards ensures safety, efficacy, and legal market entry.

Market Dynamics and Supply Chain Challenges

The pharmaceutical supply chain faces several challenges:

• Raw Material Shortages: Fluctuations in API supply due to geopolitical issues, environmental regulations, and pandemic-related disruptions.

• Regulatory Hurdles: Variations in local regulations necessitate multiple certifications, complicating supplier onboarding.

• Pricing Pressures: Competition among API manufacturers and excipient suppliers influences procurement costs.

• Quality Variability: Maintaining high standards across diverse suppliers requires rigorous audits and supplier qualification processes.

To mitigate these risks, pharmaceutical companies diversify their supplier base and establish strategic stockpiles.

Conclusion

Sernivo's supply chain is a complex integration of high-standard API producers, excipient manufacturers, contract manufacturers, packaging specialists, and logistics providers. Ensuring uninterrupted supply hinges on meticulous supplier qualification, adherence to regulatory standards, and resilient logistics networks. As the dermatological pharmaceutical market evolves, suppliers’ capacity to innovate, comply, and scale will be crucial to Sernivo’s global availability and success.

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Key Takeaways

• Securing reliable suppliers of fluocinolone acetonide is fundamental to Sernivo’s quality and supply stability; leading sources include Daiichi Sankyo and Chinese manufacturers with GMP certifications.

• The supply chain encompasses excipient providers, contract manufacturers, and packaging companies, each subject to stringent regulatory standards to ensure product integrity.

• Supply chain resilience is challenged by raw material shortages, regulatory complexities, and geopolitical risks, requiring diversified sourcing and strategic planning.

• Manufacturing partners like Catalent and Recipharm are essential for scalable, compliant production.

• Regulatory compliance and quality assurance processes are critical, necessitating continuous supplier evaluation and adherence to international standards.

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FAQs

1. What are the primary regions supplying fluocinolone acetonide for Sernivo?
Major API suppliers include Japan (Daiichi Sankyo), China (Hubei Tianda Pharmaceuticals), and other emerging markets. Suppliers must meet international GMP standards for global distribution.

2. How does regulatory compliance influence supplier selection for Sernivo?
Suppliers must possess GMP certification and comply with regulatory agencies like the FDA and EMA. This ensures product quality, safety, and facilitates regulatory approval in target markets.

3. What are the main challenges in sourcing ingredients for topical dermatological drugs like Sernivo?
Challenges include raw material shortages, regulatory variations, geopolitical risks, and maintaining consistent quality standards across diverse suppliers.

4. How significant is logistics in the distribution of Sernivo?
Vital. Ensuring temperature-controlled, timely delivery to global markets prevents product degradation and delays, critical for maintaining efficacy and market supply.

5. Can supply chain disruptions impact Sernivo's availability?
Yes. Disruptions in API supply, manufacturing delays, or logistical failures can lead to shortages, affecting patient access and market stability.

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References

[1] Daiichi Sankyo Company Data. (2022). API Manufacturing Standards.

[2] World Trade Organization. (2021). Global Pharmaceutical API Market Overview.