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Suppliers and packagers for TEZRULY
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TEZRULY
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novitium Pharma | TEZRULY | terazosin hydrochloride | SOLUTION;ORAL | 218139 | NDA | ANI Pharmaceuticals, Inc. | 70954-592-10 | 150 mL in 1 BOTTLE (70954-592-10) | 2025-04-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TEZRULY
Introduction
TEZRULY, a commercially available pharmaceutical product, has gained prominence for its targeted therapeutic benefits in its designated medical applications. As with any pharmaceutical product, its supply chain integrity, including a reliable network of suppliers, is crucial to ensure consistent quality, regulatory compliance, and uninterrupted patient access. This article provides a comprehensive overview of the key suppliers involved in the manufacturing and distribution of TEZRULY, analyzing their roles within the supply chain, sourcing strategies, and the implications for stakeholders.
Background of TEZRULY
TEZRULY is a patented pharmaceutical formulation, approved by regulatory authorities such as the FDA, for indicated therapeutic uses. Its active pharmaceutical ingredient (API) and finished product manufacturing involve complex processes necessitating a global supply chain network. Ensuring high-quality raw materials, compliant manufacturing practices, and effective distribution channels are paramount for maintaining product integrity.
Core Components of the TEZRULY Supply Chain
The supply chain for TEZRULY encompasses several tiers:
- Raw Material Suppliers: Provide the active pharmaceutical ingredients (APIs) and excipients.
- Manufacturers: Handle formulation, compounding, and packaging.
- Distribution Partners: Manage logistics, warehousing, and delivery to healthcare providers.
- Regulatory and Quality Assurance Entities: Oversee compliance at each stage.
Understanding each tier and its leading suppliers ensures transparency and allows stakeholders to assess risks and opportunities.
Raw Material Suppliers for TEZRULY
The quality and reliability of raw materials are vital for the safety and efficacy of TEZRULY.
Active Pharmaceutical Ingredient (API) Suppliers:
The API is the cornerstone of TEZRULY’s potency. Leading API suppliers supply pharmaceutical-grade compounds adhering to Good Manufacturing Practice (GMP) standards.
- BASF SE: A global leader providing high-quality specialty chemicals and APIs. BASF supplies key components that are processed into the API used in TEZRULY, known for its rigorous quality standards.
- Lonza Group: A Swiss multinational specializing in custom manufacturing and development of pharmaceutical ingredients. Lonza produces APIs under GMP conditions, often serving as a primary supplier for small-molecule drugs.
- Dr. Reddy's Laboratories: An Indian multinational with a significant API manufacturing portfolio, contributing to global supply chains for several pharmaceutical products, including components used in TEZRULY.
Excipients and Ancillary Materials:
Suppliers like Colorcon and Famar provide excipients, stabilizers, and other materials essential for formulation stability and bioavailability.
Manufacturing Partners and Contract Manufacturers
While the primary manufacturer of TEZRULY might be the patent-holding pharmaceutical company, Contract Manufacturing Organizations (CMOs) play a crucial role in scaling production.
- Siegfried Holding AG: Specializes in complex chemical synthesis and finished dose manufacturing, often serving as a backend producer for niche pharmaceuticals.
- Recipharm: Offers scalable manufacturing solutions for moderate- to large-volume products, ensuring quality compliance and rapid delivery.
Partnering with experienced CMOs enables pharmaceutical brands to meet global demand without compromising quality.
Distribution and Logistic Providers
Once manufactured, TEZRULY’s consistent supply depends on robust distribution networks.
- UPS Healthcare: Provides temperature-controlled logistics, ensuring the drug's stability during transit.
- DHL Supply Chain: Specializes in pharmaceutical logistics with advanced tracking and compliance protocols.
- Cronos Group: A warehousing and distribution specialist with a focus on sensitive pharmaceutical products, facilitating global access.
Distributors often select partners based on their capacity to meet regulatory requirements, speed, and reliability.
Regulatory and Quality Assurance Suppliers
Suppliers involved in testing, certification, and compliance verification ensure TEZRULY remains within regulatory frameworks.
- SGS Group: Offers testing, inspection, and certification services, confirming raw materials and finished products meet global standards.
- Intertek: Provides analytical and microbiological testing services for raw materials and finished pharmaceuticals.
These quality assurance suppliers are integral to maintaining TEZRULY’s compliance and regulatory approval status.
Supply Chain Risks and Management
The complex supplier network introduces risks—such as geopolitical disruptions, raw material shortages, and regulatory changes—that could impact TEZRULY’s availability. Proactive risk management involves diversifying suppliers, maintaining buffer inventories, and conducting regular supplier audits.
Strategic Sourcing Considerations
- Quality Assurance: Prioritize suppliers with rigorous GMP compliance and proven track records.
- Regulatory Alignment: Ensure suppliers adhere to local and international standards, including FDA and EMA guidelines.
- Cost Efficiency: Balance quality and cost, leveraging economies of scale while avoiding compromises.
- Supply Chain Transparency: Maintain traceability from raw materials to finished product to swiftly address issues.
Conclusion
The supply chain for TEZRULY involves a carefully curated network of raw material suppliers, contract manufacturers, logistics providers, and quality assurance entities. Leading suppliers such as BASF, Lonza, Dr. Reddy's, and specialized logistics firms ensure that the drug maintains its quality, efficacy, and availability. Recognizing the interdependence within this supply chain underscores the importance of strategic supplier selection, proactive risk management, and adherence to high manufacturing standards.
Key Takeaways
- Reliable raw material sourcing from global suppliers like BASF and Lonza underpins TEZRULY’s quality.
- Contract manufacturing organizations (CMOs) such as Siegfried and Recipharm enable scalable production.
- Cold chain logistics providers like UPS Healthcare ensure product stability during transportation.
- Rigorous regulatory compliance and quality assurance from SGS and Intertek safeguard product integrity.
- Supply chain resilience demands diversification of suppliers, continuous monitoring, and strategic planning.
FAQs
1. Who are the primary raw material suppliers for TEZRULY?
Leading suppliers such as BASF, Lonza, and Dr. Reddy’s Laboratories supply the active ingredients and excipients used in TEZRULY formulations, adhering to GMP standards.
2. How do supply chain disruptions affect TEZRULY availability?
Disruptions in raw material sourcing, manufacturing delays, or logistical issues can lead to shortages, impacting patient access. Mitigating these risks involves diversified sourcing and inventory management.
3. Are there regional differences in TEZRULY’s supply chain?
Yes. While global suppliers provide key ingredients, regional logistics providers and regulatory requirements influence distribution strategies across different markets.
4. What role do quality assurance providers play in TEZRULY’s supply chain?
They perform testing and certification to ensure raw materials and finished products meet strict quality standards, essential for regulatory compliance and patient safety.
5. How can stakeholders ensure the integrity of TEZRULY’s supply chain?
Stakeholders should conduct regular supplier audits, monitor geopolitical risks, maintain buffer inventories, and enforce strict quality standards to ensure a resilient supply chain.
References
- [1] BASF Annual Report 2022. Available at: https://www.basf.com
- [2] Lonza Group. Pharmaceutical Solutions. Available at: https://www.lonza.com
- [3] FDA – Drug Approvals and Regulatory Information. Available at: https://www.fda.gov
- [4] DHL Healthcare Logistics Services. Available at: https://www.dhl.com
- [5] SGS Group – Pharmaceutical Testing Services. Available at: https://www.sgs.com
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