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Suppliers and packagers for TRANSDERM SCOP
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TRANSDERM SCOP
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Baxter Hlthcare Corp | TRANSDERM SCOP | scopolamine | SYSTEM;TRANSDERMAL | 017874 | NDA | Baxter Healthcare Corporation | 10019-008-04 | 4 POUCH in 1 BOX (10019-008-04) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH | 2016-12-01 |
| Baxter Hlthcare Corp | TRANSDERM SCOP | scopolamine | SYSTEM;TRANSDERMAL | 017874 | NDA | Baxter Healthcare Corporation | 10019-008-10 | 10 POUCH in 1 BOX (10019-008-10) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH | 2016-12-01 |
| Baxter Hlthcare Corp | TRANSDERM SCOP | scopolamine | SYSTEM;TRANSDERMAL | 017874 | NDA | Baxter Healthcare Corporation | 10019-008-24 | 24 POUCH in 1 BOX (10019-008-24) / 1 PATCH in 1 POUCH / 3 d in 1 PATCH | 2016-12-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Transderm Scop (Scopolamine)
Introduction
Transderm Scop, a transdermal patch containing scopolamine, is widely prescribed for motion sickness and postoperative nausea. As a crucial pharmaceutical product, the supply chain's robustness hinges on a well-established network of reputable manufacturers and suppliers. This overview delineates key suppliers, their manufacturing capacities, regulatory status, and market presence to aid stakeholders in making well-informed sourcing decisions.
Background on Transderm Scop
Transderm Scop delivers scopolamine via a skin patch, offering sustained medication release over several days. It has secured approvals from agencies like the FDA and EMA, underscoring its safety and efficacy profile. The active pharmaceutical ingredient (API), scopolamine hydrobromide, is produced by multiple suppliers globally, which are integral to the manufacturing of transdermal patches by various pharmaceutical companies.
Major Raw Material Suppliers: Scopolamine API
1. Companies Producing Scopolamine API
a. Euticals and Pharmaceutical Contract Manufacturers
- Siegfried AG (Switzerland): A leading producer of APIs, including scopolamine, Siegfried supplies to top global pharma companies under strict regulatory compliance. Their facilities adhere to cGMP standards, ensuring product purity and quality.
- Jubilant Life Sciences (India): A major API manufacturer with extensive experience in alkaloid-based APIs, Jubilant supplies bulk scopolamine for both generic and branded products. Their global certifications include WHO-GMP, EMA, and US-FDA approvals[1].
- Société des Produits Chimiques et Pharmaceutiques (SPCP) (France): Specializes in plant-derived alkaloids, including scopolamine, with supply agreements for pharmaceutical companies seeking plant-extracted APIs.
b. Specialty Chemical Suppliers
- BDL (Biochemical Derivatives Limited) (India): Offers scopolamine hydrobromide API, focused on high purity standards suitable for pharmaceutical applications. Complies with international pharmacopoeia standards.
- Venus Remedies (India): Provides bulk API supplies, including scopolamine, for internal and external manufacturing, supporting the supply chain robustness during high-demand periods.
2. Manufacturing Regulatory Standards
Most leading API producers monitor compliance with Good Manufacturing Practices (GMP) to ensure safety and efficacy. Companies such as Siegfried and Jubilant have cGMP-certified facilities approved by global authorities, which is critical for market authorization of finished Transderm Scop patches.
Finished Dosage Form Manufacturers
3. Companies Producing Transderm Scop Patches
While many pharmaceutical companies seek to manufacture transdermal patches in-house, several contract manufacturing organizations (CMOs) serve as pivotal suppliers:
- Novartis: Historically involved in licensing and manufacturing Transderm Scop via internal facilities, ensuring quality control.
- Mylan/Viatris: Known for generic formulations, including transdermal patches, with manufacturing sites approved by regulatory bodies.
- Glenmark Pharmaceuticals: Recognized for transdermal technology, often collaborating with CMOs for patch production.
- Boehringer Ingelheim: Engaged in research and manufacturing partnerships for transdermal drug delivery systems, including scopolamine patches.
4. Contract Manufacturing Organizations (CMOs)
Numerous CMOs provide transdermal patch manufacturing:
- Recipharm (Sweden): Offers complete development and manufacturing services for transdermal patches.
- VaccinePro (India): Provides GMP-compliant manufacturing for transdermal systems, supporting smaller and large-scale production.
- Catalent (USA): A global leader providing API supply and finished dosage manufacturing, with expertise in transdermal drug delivery.
Supply Chain Dynamics and Market Considerations
The supply chain for Transderm Scop encompasses raw material extraction, API manufacturing, and final patch assembly. Factors affecting supplier selection include:
- Regulatory compliance and certifications: Suppliers must meet stringent standards set by agencies like the FDA, EMA, and WHO.
- Manufacturing capacity and scalability: Global demand levels influence supplier choice. Notable shortages during pandemic periods underscore the importance of diversified sourcing.
- Quality assurance and consistency: Reliable suppliers with proven track records minimize regulatory risks and ensure consistent product quality.
- Geopolitical stability: Sourcing from stable regions mitigates risks related to supply disruptions.
Emerging Trends and Future Outlook
- Bio-sourcing and Plant-derived APIs: Increasing emphasis on plant-based production methods for scopolamine can diversify supply sources.
- Regulatory harmonization: Stricter global standards will filter into supplier qualification processes, favoring suppliers with international approvals.
- Supply chain diversification: Pharmaceutical companies are adopting multiple sourcing strategies to reduce dependency on a limited set of suppliers.
- Technological advancements: Innovations in transdermal delivery systems and manufacturing techniques may alter the dynamics of supplier requirements.
Conclusion
The supply chain for Transderm Scop is well-established, with reputable API manufacturers like Siegfried AG and Jubilant Life Sciences forming the backbone of raw material provision. Finished product manufacturing involves a combination of pharmaceutical companies and specialized CMOs capable of producing high-quality transdermal patches at scale. Due to regulatory complexity and supply chain sensitivities, diversification of suppliers, rigorous quality standards, and compliance with international regulations are essential for uninterrupted supply.
Key Takeaways
- Ensure API sourcing from GMP-certified, globally approved manufacturers like Siegfried AG and Jubilant Life Sciences.
- Prefer pharmaceutical companies with established manufacturing capabilities and regulatory track records for finished patches.
- Diversify sources across geographies to mitigate geopolitical risks and supply disruptions.
- Incorporate suppliers with proven quality assurance measures aligned with international standards.
- Monitor emerging biotechnology trends and regulatory reforms that could impact the supply landscape.
FAQs
1. Who are the top API suppliers for scopolamine?
Major API suppliers for scopolamine include Siegfried AG, Jubilant Life Sciences, and Venus Remedies, all with global GMP certifications and extensive manufacturing expertise.
2. Can I source Transderm Scop from multiple manufacturers?
Yes, to ensure supply stability, it is advisable to establish relationships with multiple certified manufacturers for both API and finished patches.
3. What are the regulatory considerations when sourcing suppliers?
Suppliers must hold approvals from agencies like the FDA, EMA, or WHO-GMP certifications, demonstrating compliance with safety and quality standards.
4. Are there bio-sourced alternatives for scopolamine?
Research is ongoing into plant-derived alkaloids for scopolamine, which could diversify raw material sources and improve sustainability.
5. How does supply chain diversification affect pricing and availability?
Diversification enhances supply security but may influence costs; balancing quality, reliability, and cost is fundamental for procurement strategies.
Sources:
[1] Global Pharmaceutical API Market Report 2022, IQVIA.
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