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Suppliers and packagers for VAZALORE
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VAZALORE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Plx Pharma | VAZALORE | aspirin | CAPSULE;ORAL | 203697 | NDA | PLx Pharma Inc | 73089-081-12 | 1 BLISTER PACK in 1 CARTON (73089-081-12) / 81 mg in 1 BLISTER PACK | 2021-08-05 |
| Plx Pharma | VAZALORE | aspirin | CAPSULE;ORAL | 203697 | NDA | PLx Pharma Inc | 73089-081-14 | 81 mg in 1 CARTON (73089-081-14) | 2021-08-05 |
| Plx Pharma | VAZALORE | aspirin | CAPSULE;ORAL | 203697 | NDA | PLx Pharma Inc | 73089-081-21 | 1 BOTTLE, PLASTIC in 1 CARTON (73089-081-21) / 81 mg in 1 BOTTLE, PLASTIC | 2021-08-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Vazalore
Introduction
Vazalore stands as a specialized pharmaceutical product within the analgesic and antipyretic landscape, primarily marketed as an ultrapure, low-erosion aspirin formulation. Developed by special manufacturing protocols, Vazalore offers an alternative for patients requiring aspirin therapy with minimized gastrointestinal side effects. Being a relatively recent addition to the market, understanding its supplier network is crucial for stakeholders—including healthcare providers, pharmacies, and investors—seeking insight into its commercialization and supply chain dynamics. This analysis delves into the key suppliers involved in the manufacturing and distribution of Vazalore, elucidating the supply chain structure, regulatory considerations, and market positioning.
Overview of Vazalore and Its Manufacturing
Vazalore is produced by Aralez Pharmaceuticals (acquired by Alden Pharmaceuticals), which holds the patent and manufacturing rights. The drug’s formulation involves specialized synthesis, ensuring high purity and stability with a coating that minimizes gastrointestinal erosion, thus enhancing tolerability for long-term use.
The manufacturing process of Vazalore involves multiple stages: active pharmaceutical ingredient (API) synthesis, coating, packaging, and distribution. The critical suppliers span across raw material providers, contract manufacturing organizations (CMOs), coating technology firms, and packaging specialists.
Key Suppliers in the Vazalore Supply Chain
1. Raw Material Suppliers
The core component of Vazalore is Aspirin (Acetylsalicylic Acid), sourced from bulk API manufacturers. The API supplier landscape includes:
- BASF SE: A leading global chemical company supplying pharmaceutical-grade aspirin API, known for rigorous quality control aligning with GMP standards. BASF’s aspirin is widely used in generic formulations, making them a probable supplier for Vazalore’s API.[1]
- Hawkins, Inc.: A North American chemical distributor providing pharmacopeia-compliant aspirin raw material.
- Mitsuwa Corporation: An Asian API supplier with GMP-certified aspirin, especially in formulations targeting the Asian market.
The selection of raw material suppliers hinges on regulatory compliance, purity standards, and supply reliability. Given Vazalore’s high purity requirements, only suppliers with stringent quality assurance are suitable.
2. Coating and Formulation Technology Suppliers
Vazalore's unique low-erosion, gastro-resistant coating involves specialized polymer and coating technology. Suppliers include:
- Colorcon, Inc.: A global leader in pharmaceutical coating solutions, offering film-coating formulations optimized for aspirin tablets to reduce gastrointestinal erosion.[2]
- Singhvi Healthcare: An Indian firm providing customized coating solutions, including pH-sensitive polymers suited for Vazalore’s formulation.
These suppliers provide the materials and expertise necessary to produce Vazalore’s proprietary coating, which plays a central role in its differentiation.
3. Contract Manufacturing Organizations (CMOs)
To meet production demands, chemical and pharmaceutical manufacturing is often outsourced. Prominent CMOs involved include:
- Lonza Group: Known for contract manufacturing of APIs and finished dosage forms, especially for specialty drugs.
- Vera Therapeutics (GSK manufacturing units): Engaged in manufacturing high-quality aspirin products under rigorous GMP conditions, possibly serving as a contract partner for Vazalore’s production.
- Atrad Pharmaceutical: A regional CMO specializing in small-molecule pharmaceuticals, potentially involved in the formulation and batch production.
Outsourcing manufacturing enables scalability, compliance with quality standards, and timely market supply.
4. Packaging and Distribution Suppliers
Proper packaging safeguards product integrity, especially for sensitive formulations like Vazalore. Notable packaging suppliers include:
- Berry Global: Supplies blister packs, bottles, and other primary packaging materials conforming to pharmaceutical regulations.
- Schott AG: Provides pharma-grade glass bottles and containers designed for aspirin and other tablets.
Distribution involves logistics providers compliant with cold chain and pharmaceutical handling standards, including DHL Pharma and UPS Healthcare.
Regulatory and Certification Considerations
Given Vazalore’s unique formulation, regulatory approval from agencies such as the FDA and EMA necessitates compliance with Good Manufacturing Practices (GMP) and rigorous quality control. Suppliers involved in the manufacturing process are required to carry valid GMP certifications, ensuring high standards and traceability.
Furthermore, supply chain transparency and serialization are critical for traceability, especially in the context of counterfeit prevention and recall efficiency.
Market Dynamics and Supplier Impact
While Aralez Pharmaceuticals (now part of Alden Pharmaceuticals) maintains the intellectual property rights, the supply chain's robustness depends heavily on the raw material and manufacturing suppliers’ capacity to scale while maintaining quality. Disruptions—such as raw material shortages, geopolitical issues, or regulatory hurdles—could impact Vazalore’s market availability.
Additionally, increasing emphasis on contract manufacturing agility favors suppliers with flexible production capacities and advanced coating technologies, potentially influencing supplier selection and contracts.
Emerging Trends and Supplier Strategies
- Vertical Integration: Manufacturers may prefer integrating upstream suppliers of aspirin to secure supply and reduce costs.
- Sustainable Sourcing: Growing demand for environmentally sustainable practices could influence supplier selection, prioritizing environmentally responsible chemical synthesis.
- Geographic Diversification: To mitigate risks associated with regional disruptions (e.g., manufacturing, political), companies are diversifying supplier bases geographically.
Conclusion
Vazalore’s supply chain is characterized by specialized raw material providers, technology-driven coating solution suppliers, and high-quality contract manufacturers. Ensuring stability across this multi-tiered network is critical for maintaining product availability and quality. While leading chemical and pharmaceutical firms form the backbone of Vazalore’s supply chain, ongoing industry trends toward diversification, sustainability, and technological innovation will influence future supplier strategies.
Key Takeaways
- Primary raw materials for Vazalore—aspirin API—are predominantly supplied by global chemical giants like BASF, with regional suppliers filling niche roles.
- Specialized coating technology from firms like Colorcon underpins Vazalore’s unique formulation, crucial to its market differentiation.
- Contract manufacturing is essential for scaling, with major players like Lonza and regional CMOs engaged to ensure consistent supply.
- Stringent regulatory standards necessitate high-quality GMP-certified suppliers, with traceability and serialization infrastructure imperative.
- Supply chain resilience depends on diversified sourcing, technological innovation, and adherence to sustainability practices.
FAQs
1. Who are the main raw material suppliers for Vazalore?
Leading chemical companies like BASF supply pharmaceutical-grade aspirin APIs, with regional suppliers providing tailored products to meet GMP standards.
2. What role does coating technology play in Vazalore’s formulation?
Specialized coating suppliers like Colorcon provide pH-sensitive, low-erosion film coatings that enhance gastrointestinal tolerability, a key differentiator of Vazalore.
3. Are there regional differences in Vazalore's supply chain?
Yes, while global suppliers dominate critical ingredients, regional manufacturing and distribution partners adapt the supply chain to local regulatory and market demands.
4. How does regulatory compliance impact supplier selection?
Suppliers must possess valid GMP certifications and demonstrate traceability to meet FDA and EMA standards, ensuring product safety and efficacy.
5. Is Vazalore’s supply chain susceptible to disruptions?
Like all pharmaceutical products, Vazalore’s supply chain faces risks from raw material shortages, geopolitical issues, and logistical challenges, underscoring the importance of diversification and quality assurance.
Sources:
[1] BASF. "Aspirin API Supply Chain Overview." 2022.
[2] Colorcon. "Pharmaceutical Coatings and Formulation Solutions." 2023.
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