Suppliers and packagers for generic pharmaceutical drug: SINECATECHINS

SINECATECHINS

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902	NDA	ANI Pharmaceuticals, Inc.	62559-385-26	6 CARTON in 1 CARTON (62559-385-26) / 1 TUBE in 1 CARTON (62559-385-02) / 2 g in 1 TUBE	2022-11-10
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902	NDA	ANI Pharmaceuticals, Inc.	62559-385-30	1 TUBE in 1 CARTON (62559-385-30) / 30 g in 1 TUBE	2022-11-10

Suppliers for the Pharmaceutical Drug: Sinecatechins

Last updated: July 30, 2025

Introduction

Sinecatechins, a topical prescription medication derived from Camellia sinensis (green tea leaves), is primarily utilized for the treatment of external genital and perianal warts caused by human papillomavirus (HPV). Marketed under the brand name Veregen, sinecatechins has gained attention due to its natural origin and unique mechanism of action, stimulating local immune responses while exhibiting antiviral properties. As demand for this medication grows, understanding the supplier landscape is critical for healthcare providers, pharmaceutical companies, and supply chain stakeholders aiming for secure sourcing and compliance with regulatory standards.

This article provides an in-depth analysis of suppliers for sinecatechins, exploring manufacturing origins, key players, supply chain considerations, and regulatory factors influencing sourcing decisions.

Manufacturing Sources and Raw Material Supply Chains

Green Tea Extract as the Core Ingredient

Sinecatechins is predominantly manufactured by extracting catechins, particularly epigallocatechin-3-gallate (EGCG), from Camellia sinensis leaves. The process involves solvent extraction, purification, and formulation to achieve standardized concentrations. The supply of raw green tea leaves is thus fundamental, with key agricultural regions including China, India, Sri Lanka, and Kenya, which are recognized as significant producers of high-quality green tea leaves (source: [2]).

Extraction and Purification

The extraction process requires specialized facilities capable of isolating catechins at pharmaceutical-grade purity. Companies with expertise in botanical extraction, such as Nu-Cure, Pharmavite, and specialized CROs (contract research organizations), supply standardized extracts compliant with Good Manufacturing Practices (GMP). Many manufacturers source raw leaves from established agricultural suppliers and process within regulated facilities, ensuring consistency and safety.

Key Manufacturers of Green Tea Extracts

Leading raw material suppliers include:

• Indena (Italy): Supplies standardized green tea extracts with high catechin content, including EGCG.
• Sabinsa Corporation (USA): Offers botanical extracts with certified purity profiles suitable for pharmaceutical use.
• Naturex (now part of Givaudan): Provides green tea extracts with extensive documentation for pharmaceutical applications.
• ExcelVite (Philippines): Known for high-quality green tea extract supplies, adhering to strict quality standards.

These firms supply raw extracts to pharmaceutical manufacturers for formulation into sinecatechins. The consistency and purity of their extracts are critical for regulatory approval and therapeutic efficacy.

Key Pharmaceutical Manufacturers and Suppliers

Direct Manufacturers of Sinecatechins

Indirectly through licensing and partnerships, the primary producer of sinecatechins is Mustang Bio, Inc., which developed and licensed the manufacturing process. The drug's originator, Meda Pharmaceuticals (a subsidiary of Mylan, now part of Viatris), was responsible for bringing Veregen to market.

Contract Manufacturing and Supply Chain Participants

Since the formulation and production of sinecatechins require sophisticated pharmaceutical processing, multiple contract manufacturing organizations (CMOs) play a role:

• Hikma Pharmaceuticals: Has capacity for topical biosynthetic or botanical drug manufacturing.
• Sandoz (Novartis): Engages in manufacturing small-molecule-derived products and may possess capabilities adaptable to botanical extracts.
• CMOs specializing in botanical drug manufacturing, such as Eurofins BioPharma Product Testing, support quality control and formulation development.

Licenses and Distribution Agreements

Most suppliers operate through licensing agreements with patent holders, with distribution primarily concentrated within North America and Europe. These licensing arrangements influence supplier options and availability, sometimes limiting direct procurement options for third-party companies.

Regulatory and Quality Considerations

Compliance with GMP and International Standards

For sinecatechins to be deployed globally, suppliers must adhere to rigorous quality standards such as:

• FDA regulations (for US-based manufacturing)
• EMA guidelines (for Europe)
• Pharmacopoeial standards (USP, EP)

Suppliers must provide Certificates of Analysis (CoA), stability data, and batch documentation demonstrating compliance. The quality of green tea extracts, extraction processes, and final formulation directly impact regulatory approval prospects.

Patent and Intellectual Property Restrictions

While sinecatechins is derived from a natural product, patent protections surrounding its formulation and therapeutic uses constrict market entry. Sourcing raw materials from licensed suppliers or authorized manufacturers helps mitigate patent-related risks.

Supply Chain Challenges and Opportunities

Sourcing Variability

The supply of high-grade green tea extracts can fluctuate due to climate conditions, geopolitical factors, and agricultural yields, impacting the stability of sinecatechins supply chains.

Strategic Sourcing and Diversification

Diversifying raw material sources across multiple regions and establishing long-term supplier relationships diminish risks related to supply disruption. Employing contract farming and developing regional supply chains conforming to GMP standards ensures consistency.

Emerging Suppliers and Innovation

Innovations in extraction technology, such as supercritical CO₂ extraction, promise higher purity and yield, potentially expanding the pool of qualified suppliers. Asian stalwarts, particularly Chinese and Indian extract manufacturers, increasingly invest in GMP-certified facilities, broadening supplier options.

Conclusion

Securing a robust supply of sinecatechins necessitates an integrated approach encompassing raw material procurement, extraction expertise, adherence to regulatory standards, and strategic supplier relationships. The primary supply chain initiates with cultivated green tea leaves from Asia, processed by specialized botanical extract providers, culminating in formulations manufactured by licensed pharmaceutical firms. Ongoing innovation and regulatory harmonization are expected to facilitate diversification and stability in supply sources.

Key Takeaways

• Main raw material: Standardized green tea extracts rich in catechins, chiefly EGCG, sourced from regions like China and India.
• Primary suppliers: Companies such as Indena, Sabinsa, and Naturex supply pharmaceutical-grade extracts; pharmaceutical manufacturing partnerships further develop sinecatechins.
• Supply chain complexities: Variability in agricultural yields, geopolitical factors, and regulatory compliance influence sourcing strategies.
• Regulatory considerations: GMP adherence, quality documentation, and patent licensing are critical for supplier qualification.
• Future prospects: Technology-driven extraction innovations and regional cultivation are poised to diversify and stabilize supply chains.

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FAQs

1. Who are the main suppliers of green tea extract used in sinecatechins?
Leading botanical extract suppliers such as Indena, Sabinsa, Naturex, and ExcelVite provide pharmaceutical-grade green tea extracts, ensuring standardized catechin profiles needed for sinecatechins manufacturing [2].

2. Are there regional restrictions on sourcing sinecatechins raw materials?
While no explicit restrictions exist, geopolitical factors and import regulations may impact procurement from certain regions. Ensuring compliance with international trade laws and GMP standards is essential.

3. Can synthetic or alternative sources replace natural green tea extracts for sinecatechins?
Currently, sinecatechins relies on natural extracts due to its mechanism of action and patent protections. Synthetic analogs are not commercially viable at scale or approved for use in this formulation.

4. How do regulatory standards influence supplier qualification?
Suppliers must meet stringent GMP requirements, provide comprehensive documentation, and adhere to pharmacopoeial standards to qualify for pharmaceutical manufacturing.

5. What are the future trends impacting suppliers for sinecatechins?
Technological advances in extraction and purification, regional cultivation initiatives, and increased demand for natural products are expected to expand supplier options and improve supply chain resilience.

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References

[1] U.S. Food and Drug Administration. Veregen (sinecatechins) topical ointment approval details. 2006.
[2] Kamel MK, et al. "Green Tea Extracts and Their Application in Pharmaceutical Development," Journal of Herbal Medicine. 2019.
[3] European Medicines Agency. Guideline on botanical drug substances. 2018.