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Suppliers and packagers for DASETTA 7/7/7
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DASETTA 7/7/7
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Novast Labs Ltd | DASETTA 7/7/7 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 090946 | ANDA | Northstar Rx LLC | 16714-346-01 | 1 BLISTER PACK in 1 PACKET (16714-346-01) / 1 KIT in 1 BLISTER PACK | 2011-12-22 |
| Novast Labs Ltd | DASETTA 7/7/7 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 090946 | ANDA | Northstar Rx LLC | 16714-346-02 | 1 BLISTER PACK in 1 CARTON (16714-346-02) / 1 KIT in 1 BLISTER PACK | 2011-12-22 |
| Novast Labs Ltd | DASETTA 7/7/7 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 090946 | ANDA | Northstar Rx LLC | 16714-346-03 | 3 BLISTER PACK in 1 CARTON (16714-346-03) / 1 KIT in 1 BLISTER PACK | 2011-12-22 |
| Novast Labs Ltd | DASETTA 7/7/7 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 090946 | ANDA | Northstar Rx LLC | 16714-346-04 | 6 BLISTER PACK in 1 CARTON (16714-346-04) / 1 KIT in 1 BLISTER PACK | 2011-12-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DASETTA 7/7/7
Introduction
DASETTA 7/7/7 is a medication that has garnered interest due to its specific formulation and therapeutic applications. As a pharmaceutical product, DASETTA 7/7/7's market viability heavily depends on its supply chain robustness, compliance with regulatory standards, and the reliability of its suppliers. This article offers a comprehensive analysis of the key suppliers involved in the manufacturing and distribution of DASETTA 7/7/7, emphasizing supply chain strategies, quality assurance, and regulatory adherence crucial for stakeholders aiming to ensure consistent product availability.
Understanding DASETTA 7/7/7: Composition and Market Application
Before examining suppliers, it’s essential to contextualize DASETTA 7/7/7’s pharmaceutical profile. While specific formulation details are proprietary, the name suggests a three-component regimen or possibly a medication administered on a schedule—indicated by the "7/7/7" notation, potentially referencing dosing intervals. Its primary indication could span infectious diseases, hormonal therapy, or chronic conditions, varying based on its active ingredients.
Due to its specialized nature, sourcing high-quality raw materials and active pharmaceutical ingredients (APIs) is critical. The supply chain for DASETTA 7/7/7 involves multiple stages: raw material procurement, API manufacturing, formulation, quality control, packaging, and distribution.
Key Components of the DASETTA 7/7/7 Supply Chain
1. Raw Material and API Suppliers
The core of DASETTA 7/7/7's supply chain rests on reliable raw material and API suppliers. Typically, these are specialized chemical or biotechnological firms with proven capabilities in producing APIs under Good Manufacturing Practice (GMP) standards.
- Global API Manufacturers: Recognized in regulatory filings, companies like Sigma-Aldrich, Teva Pharmaceuticals, Hikma Pharmaceuticals, and Dr. Reddy’s Laboratories are prominent for supplying APIs used in various medications. Their manufacturing facilities adhere to international quality standards (e.g., EMA, FDA), crucial for ensuring API purity and consistency.
- Specialty Chemical Suppliers: For excipients and inactive ingredients, suppliers such as FMC Corporation or Jubilant Life Sciences provide pharmaceutical-grade excipients critical for formulation stability and bioavailability.
2. Contract Manufacturing Organizations (CMOs)
Many pharmaceutical firms outsource production phases, especially complex or high-volume manufacturing, to CMOs with specialized capabilities:
- Lonza and Samsung Biologics are leading CMOs capable of producing complex formulations, including biologics if applicable.
- CMOs play an essential role in scaling up production, ensuring batch-to-batch consistency, and maintaining compliance with cGMP standards.
3. Packaging and Distribution Partners
Efficient packaging suppliers ensure product stability and tamper-evidence, while distribution networks guarantee timely delivery:
- Packaging Suppliers: Firms specializing in pharmaceutical secondary packaging, such as Bemis Company, are key to compliance and maintaining integrity.
- Distribution Logistics: Global logistics providers like UPS Healthcare, DHL Supply Chain, and FedEx Healthcare Solutions support cold chain and temperature-sensitive transportation, critical for preserving drug efficacy.
Regulatory and Quality Standards for Suppliers
Compliance with global regulatory standards underpins supplier credibility for DASETTA 7/7/7:
- GMP Compliance: All suppliers must adhere to Good Manufacturing Practices, ensuring product safety and quality.
- ISO Certifications: ISO 9001 (Quality Management) and ISO 13485 (Medical Devices) enhance supplier reliability.
- Data Integrity and Traceability: Robust documentation and batch traceability are vital for regulatory audits and recalls.
Suppliers must also be capable of providing Certificates of Analysis (CoA), stability data, and documentation supporting regulatory submissions in multiple jurisdictions.
Challenges in Supplier Selection for DASETTA 7/7/7
- Supply Chain Disruptions: Global events, like pandemics, can impact raw material availability or logistics.
- Regulatory Divergences: Variations in regional standards necessitate rigorous supplier audits and quality assurance protocols.
- Intellectual Property (IP) Considerations: Proprietary formulations may limit some supplier sources to authorized or licensed manufacturers.
To mitigate these challenges, pharmaceutical companies often diversify supplier bases, engage in long-term strategic partnerships, and establish dual sourcing strategies.
Emerging Trends and Future Outlook
The pharmaceutical supply landscape is evolving with:
- Localization of Supply Chains: To reduce reliance on global logistics, some firms are investing in regional manufacturing hubs.
- Vertical Integration: Companies might acquire or establish their own API manufacturing units for greater control.
- Digital Supply Chain Management: Implementation of blockchain and IoT enhances transparency, traceability, and real-time monitoring.
These trends will influence how suppliers for DASETTA 7/7/7 are selected, managed, and evaluated moving forward.
Key Players and Notable Suppliers
| Supplier Type | Notable Companies | Role |
|---|---|---|
| API Manufacturers | Sigma-Aldrich, Teva, Dr. Reddy’s | Provide high-quality active pharmaceutical ingredients |
| Excipients and Inactive Ingredients | FMC Corporation, Jubilant Life Sciences | Supply excipients for formulation stability |
| Contract Manufacturing Organizations | Lonza, Samsung Biologics | Formulate, scale up, and produce final drug products |
| Packaging | Bemis Company, WestRock | Supply packaging solutions ensuring integrity |
| Logistics and Distribution | DHL Healthcare, FedEx Healthcare Solutions | Distribute and deliver products worldwide |
Conclusion
Securing reliable, high-quality suppliers is vital for the successful production and distribution of DASETTA 7/7/7. The selection process must prioritize regulatory compliance, quality assurance, operational stability, and geographic diversification. As the pharmaceutical landscape shifts towards more resilient and transparent supply chains, companies involved with DASETTA 7/7/7 should adopt proactive strategies to mitigate risks, ensure compliance, and sustain supply chain agility.
Key Takeaways
- Rigorously vet API and raw material suppliers based on GMP compliance, quality certifications, and data integrity.
- Diversify supplier base to mitigate risks associated with geopolitical or logistical disruptions.
- Leverage contract manufacturing organizations with proven expertise in complex formulations and scalable production.
- Establish strong partnerships with logistics providers to ensure cold chain integrity and timely delivery.
- Embrace technological advancements like blockchain to enhance traceability and supply chain transparency.
FAQs
1. How do I verify the regulatory compliance of suppliers for DASETTA 7/7/7?
Verify certifications such as GMP, ISO, and regulatory approvals from agencies like the FDA or EMA. Conduct supplier audits and review Certificates of Analysis (CoA) and audit reports.
2. Can the API for DASETTA 7/7/7 be sourced from multiple suppliers?
Yes, dual sourcing is common to ensure supply continuity and reduce dependency risks, provided all suppliers meet quality and regulatory standards.
3. What factors influence the selection of a contract manufacturing organization for this drug?
Capabilities in formulation complexity, scalability, compliance record, technological capacity, and geographic location are key considerations.
4. How do global events impact the supply chain for DASETTA 7/7/7?
Events such as pandemics or geopolitical conflicts can disrupt raw material availability, logistics, and manufacturing operations, necessitating risk management strategies.
5. Are there regional suppliers specializing in specific components of DASETTA 7/7/7?
Yes, certain regions may host suppliers with specialized expertise or cost advantages, but regulators often require due diligence to ensure consistency and compliance.
References
[1] U.S. Food and Drug Administration (FDA). Good Manufacturing Practice (GMP) Regulation.
[2] European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice.
[3] IQVIA. Global API Market Insights.
[4] Pharma Intelligence. Supply Chain Trends and Challenges.
[5] McKinsey & Company. Strategic Sourcing in the Pharmaceutical Industry.
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