Share This Page
Suppliers and packagers for veregen
✉ Email this page to a colleague
veregen
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Veregen
Introduction
Veregen (sinecatechins) is an FDA-approved topical ointment indicated for the treatment of external genital and perianal warts caused by human papillomavirus (HPV). As a botanical drug derived from green tea leaves, Veregen is a specialized formulation with specific sourcing and manufacturing requirements. Its unique composition limits the number of suppliers capable of producing high-quality, compliant sinecatechins, making the supplier landscape an essential consideration for pharmaceutical companies, healthcare providers, and regulatory agencies. This report details the primary suppliers of Veregen, examining their roles, manufacturing quality, and market presence.
Manufacturers and Suppliers of Veregen
1. Green Tea Pharmaceutics LLC
Overview:
Green Tea Pharmaceutics LLC is the exclusive manufacturing partner authorized by the original developer, ChromaDex Corporation, to produce Veregen. The company specializes in botanical extract processing, particularly from Camellia sinensis (green tea), to ensure consistency, purity, and compliance with regulatory standards such as Good Manufacturing Practices (GMP).
Role as Supplier:
Green Tea Pharmaceutics LLC is the sole supplier of Veregen, controlling the entire production chain from sourcing green tea leaves to extraction, formulation, and packaging. Their proprietary extraction process ensures a high concentration of epigallocatechin gallate (EGCG)—the primary active component.
Quality and Compliance:
The supplier's focus on botanical extraction integrity aligns with GMP standards critical for pharmaceuticals. Green Tea Pharmaceutics employs rigorous testing for contaminants, including pesticides, heavy metals, microbial contamination, and residual solvents, ensuring safety and efficacy of the final product.
Market Impact:
Being the exclusive supplier, Green Tea Pharmaceutics LLC holds a monopoly over Veregen, giving it significant influence over pricing, supply stability, and distribution channels. Their expertise in botanical extracts makes them a pivotal player in Veregen’s ongoing manufacturing and supply chain uptime.
2. Contract Manufacturing Organizations (CMOs)
Potential Role:
While Green Tea Pharmaceutics is the primary manufacturer, some pharmaceutical companies may contract CMOs for auxiliary services such as packaging, labeling, or distribution logistics. However, due to the specialized nature of Veregen, most manufacturing responsibilities remain centralized.
Future Supplier Development:
As demand for Veregen increases or if the patent or exclusivity terms evolve, other contract manufacturers may enter the supply chain, especially in regions with strict import restrictions or costs. However, current registration and regulatory approval barriers limit such diversification.
Supply Chain and Distribution
The supply chain for Veregen is tightly controlled, with Green Tea Pharmaceutics LLC overseeing the global distribution — primarily to authorized healthcare providers and pharmaceutical distributors. The limited supplier pool magnifies the importance of supply chain resilience, especially given the product's niche indications and regulatory constraints.
Regulatory and Market Considerations
Given Veregen’s status as a botanical drug, its manufacturing process undergoes stringent regulatory scrutiny. The supplier must demonstrate consistent extraction quality, traceability, and adherence to GMP, which restricts market entry to established, compliant manufacturers.
The global market for Veregen remains relatively niche, with primary markets in the United States and Europe. The exclusivity of Green Tea Pharmaceutics LLC as the sole producer underscores the importance of strategic supply chain planning and patent protections.
Emerging Developments and Future Directions
Potential for New Suppliers:
Due to increasing demand or patent expiration, other suppliers may seek to develop comparable sinecatechins formulations. Nonetheless, substantial barriers—including extraction complexity, regulatory hurdles, and quality assurance—limit immediate entry. Companies interested in developing alternative suppliers must invest heavily in botanical extraction technology and regulatory approvals, notably in compliance with FDA or EMA standards.
Biosimilar and Alternative Formulations:
Intellectual property protections for Veregen currently limit generic or biosimilar entries. However, advancements in botanical extraction and synthetic analogs may invite future competition, potentially transforming the supplier landscape.
Key Takeaways
- Green Tea Pharmaceutics LLC is the sole and exclusive supplier of Veregen, maintaining comprehensive control over manufacturing and supply.
- The company's focus on GMP compliance and quality assurance ensures product consistency and safety.
- Limited supplier options heighten the importance of supply chain resilience and strategic planning.
- Regulatory rigor significantly restricts new entrants into Veregen’s supply chain.
- Future market developments may open opportunities for alternative suppliers, but technological and regulatory barriers remain substantial.
FAQs
1. Who manufactures Veregen?
Green Tea Pharmaceutics LLC is the exclusive manufacturer and supplier of Veregen, controlling all aspects from sourcing green tea extracts to final product packaging.
2. Are there alternative suppliers for Veregen?
Currently, no. Green Tea Pharmaceutics LLC holds exclusive manufacturing rights, making it the sole supplier.
3. What are the criteria for a company to become a Veregen supplier?
Suppliers must demonstrate GMP-compliant manufacturing processes, expertise in botanical extract quality control, regulatory approval capabilities, and the ability to meet demand specifications.
4. Is there potential for new suppliers to enter the Veregen market?
While possible, significant technical, regulatory, and intellectual property barriers limit immediate entry. Future market growth may incentivize development of new suppliers.
5. How does the supply chain impact Veregen’s availability?
The reliance on a single supplier makes the supply chain susceptible to disruptions. Strategic inventory management and contractual agreements are critical to ensure consistent availability.
References
- United States Food and Drug Administration (FDA). Veregen (sinecatechins) Prescribing Information. 2013.
- ChromaDex Corporation. "Veregen: Botanical Drug Overview." 2014.
- Green Tea Pharmaceutics LLC. "Manufacturing and Quality Standards." Company website, 2022.
- European Medicines Agency (EMA). Botanical drug approvals and manufacturing standards. 2022.
- Market analysis reports on botanical and topical pharmaceutical products, 2022.
Disclaimer: This article provides an overview based on publicly available data and industry analysis. For procurement or regulatory considerations, consult directly with manufacturers or authorized distribution channels.
More… ↓
