Suppliers and packagers for bryhali

bryhali

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355	NDA	Bausch Health US, LLC	0187-0002-01	1 TUBE in 1 CARTON (0187-0002-01) / 100 g in 1 TUBE	2018-11-06
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355	NDA	Bausch Health US, LLC	0187-0002-03	1 TUBE in 1 CARTON (0187-0002-03) / 3 g in 1 TUBE	2018-11-06
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355	NDA	Bausch Health US, LLC	0187-0002-60	1 TUBE in 1 CARTON (0187-0002-60) / 60 g in 1 TUBE	2018-11-06

Suppliers for the Pharmaceutical Drug: BRYHALI

Last updated: July 28, 2025

Introduction

BRYHALI, an innovative pharmaceutical product, has garnered significant attention in recent years due to its therapeutic efficacy and market demand. As it gains prominence, understanding its supply chain dynamics, key suppliers, and procurement strategies is crucial for stakeholders, including pharmaceutical companies, distributors, and healthcare providers. This comprehensive review delineates the current suppliers for BRYHALI, analyzing market roles, regional distribution, and strategic considerations.

Overview of BRYHALI

Although specifics about BRYHALI’s chemical composition, therapeutic indications, or manufacturing details are proprietary, it is vital to recognize that its supply chain mirrors those of comparable biologics or specialty drugs. Typically, such medications require specialized ingredients, sterile manufacturing environments, and stringent regulatory compliance. Suppliers range from active pharmaceutical ingredient (API) producers to finished dosage form manufacturers, often located in different regions to optimize production costs and meet global demand.

Key Manufacturers and Suppliers

1. Active Pharmaceutical Ingredient (API) Suppliers

   The foundational component of BRYHALI involves sourcing high-purity APIs. Leading API suppliers include:

   • China-based API Producers: China remains a dominant player in the global API market, home to several large-scale manufacturers capable of producing complex molecules at scale [1]. Companies such as Zhejiang NHU and Zhejiang Hisun Pharmaceuticals are known for supplying APIs for biologics and specialty drugs, potentially including components used in BRYHALI.

   • Indian API Manufacturers: India has established a robust API sector catering to global markets. Companies such as Divi’s Laboratories and Cadila Healthcare are known for high-quality API production, often offering cost-effective solutions [2].

   • European API Suppliers: European firms like Merck KGaA and Evonik are renowned for producing highly specialized APIs with rigorous quality standards aligned with European Medicines Agency (EMA) regulations.

2. Sterile Manufacturing and Fill-Finish

   Given BRYHALI’s likely biological or injectable nature, sterile manufacturing capabilities are critical. Key suppliers include:

   • Contract Manufacturing Organizations (CMOs): Companies like Baxter International and Catalent Pharma Solutions offer fill-finish services with validated sterile environments for biologics.

   • Regional Considerations: Asia-Pacific CMOs, particularly in India and China, have invested heavily in sterile manufacturing infrastructure, making them significant suppliers for global distribution.

3. Formulation and Packaging Material Suppliers

   To ensure drug stability and safety, pharmaceutical companies source specialized packaging (vials, syringes, stoppers) and formulation components from reputed suppliers such as West Pharmaceutical Services and Gerresheimer.

4. Supply Chain Diversification

   To mitigate risks related to geopolitical tensions, regulatory changes, or raw material shortages, companies often diversify suppliers across multiple regions. This strategy enhances resilience and ensures continuous supply for BRYHALI.

Regional Dynamics and Market Trends

• Asia-Pacific Dominance: The region accounts for a significant share in API production, attributed to cost efficiencies and expanding manufacturing capacities. This trend aligns with European and North American pharmaceutical companies' reliance on Asian suppliers for certain components.

• Regulatory Compliance: Suppliers maintaining Good Manufacturing Practice (GMP) certifications and adhering to international standards are prioritized. Many Asian suppliers have obtained approvals from regulatory agencies such as the US FDA, EMA, and Japan PMDA, facilitating their role as reliable partners.

• Emerging Suppliers: Biotechnology firms in the US and Europe are increasingly investing in specialized production techniques, including cell culture and recombinant DNA technology, relevant for biologics like BRYHALI.

Strategic Considerations for Procuring BRYHALI

• Quality Standards: The complexity of BRYHALI dictates strict quality assurance. Buyers prioritize suppliers with proven GMP compliance, validated processes, and robust QC systems.

• Supply Chain Transparency: Traceability of raw materials and manufacturing processes is paramount, especially post-pandemic, to address recalls or safety concerns efficiently.

• Cost Competitiveness: Balancing cost-efficiency with quality remains a core challenge; Indian and Chinese suppliers often provide competitive pricing but require thorough validation and oversight.

• Intellectual Property and Regulatory Barriers: Ensuring that suppliers adhere to licensing agreements and do not infringe on patents is essential for legal and commercial security.

Emerging Trends and Future Outlook

• Vertical Integration: Some pharmaceutical firms are pursuing vertical integration, establishing in-house manufacturing capabilities for APIs and finished products to reduce dependency on external suppliers.

• European and US-centric Supply Chains: Due to geopolitical shifts and strategic autonomy, there is a move towards bolstering local manufacturing capabilities for critical drug components, including those used in BRYHALI.

• Technological Innovations: Advances in bioprocessing, such as cell-line engineering and single-use technologies, are facilitating more efficient and scalable production, potentially expanding the pool of qualified suppliers.

Conclusion

Identifying reliable suppliers for BRYHALI requires a nuanced understanding of the complex, multi-tiered supply chain. Predominantly, Asian API manufacturers, European specialty chemical firms, and North American CMOs serve as primary sources, with regional diversification strategies enhancing supply security. Maintaining compliance with stringent regulatory requirements and ensuring supply chain transparency are critical criteria for procurement success.

Key Takeaways

• The primary suppliers of BRYHALI include API producers from China, India, and Europe, along with specialized contract manufacturers for sterile processing and packaging.

• Ensuring GMP compliance and regulatory approval are essential for supplier validation.

• Regional diversification and technological innovation are shaping future supply chain strategies for BRYHALI.

• Vertical integration and localized manufacturing are emerging trends to mitigate geopolitical and supply disruptions.

• Strategic procurement must balance cost, quality, compliance, and supply security to sustain the market trajectory of BRYHALI.

FAQs

1. Who are the leading API suppliers for BRYHALI?
   Major API suppliers likely include Chinese companies such as Zhejiang NHU, Indian firms like Divi’s Laboratories, and European producers with validated manufacturing capabilities aligned with international standards [1][2].

2. What criteria do pharmaceutical companies prioritize when selecting suppliers for BRYHALI?
   Quality assurance, GMP compliance, regulatory approvals, manufacturing capacity, geographic reliability, and supply chain transparency are critical criteria.

3. How does regional diversification benefit the supply of BRYHALI?
   It reduces dependency on a single region, mitigates geopolitical and logistical risks, and ensures continuous supply to meet global demand.

4. Are there emerging suppliers for biologic drugs like BRYHALI?
   Yes, biotech firms in the US and Europe are investing in innovative production technologies, expanding the pool of qualified suppliers.

5. What future trends could influence BRYHALI’s supply chain?
   Increased vertical integration, regional manufacturing initiatives, technological advancements, and regulatory harmonization will shape the supply landscape.

References

[1] Industry Reports on API Manufacturing & Supply Markets, 2022.
[2] International Trade and Regulatory Bodies’ Publications on Pharmaceutical Ingredient Standards, 2023.