Share This Page
Suppliers and packagers for TASCENSO ODT
✉ Email this page to a colleague
TASCENSO ODT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cycle | TASCENSO ODT | fingolimod lauryl sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 214962 | NDA | Cycle Pharmaceuticals Ltd | 70709-062-30 | 3 BLISTER PACK in 1 CARTON (70709-062-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2023-02-01 |
| Cycle | TASCENSO ODT | fingolimod lauryl sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 214962 | NDA | Cycle Pharmaceuticals Ltd | 70709-065-30 | 3 BLISTER PACK in 1 CARTON (70709-065-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 2023-02-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Tascenso ODT
Introduction
Tascenso ODT, a dissolvable oral tablet, is gaining traction as a breakthrough formulation for delivering medications efficiently and patient-friendly. As a strategically positioned product within the pharmaceutical landscape, identifying reliable suppliers for Tascenso ODT is crucial for manufacturers, distributors, and healthcare providers aiming to ensure consistent supply, compliance, and quality. This analysis delineates the landscape of suppliers, including established contract manufacturing organizations (CMOs), raw material providers, and regional distributors, alongside regulatory considerations impacting supply chain decisions.
Overview of Tascenso ODT
Tascenso ODT (Orally Disintegrating Tablet) is an innovative dosage form designed for rapid dissolution in the mouth without the need for water. Its advantages include improved patient compliance, especially among pediatric, geriatric, or dysphagic populations, and enhanced bioavailability for certain therapeutic agents. The formulation typically involves specialized excipients such as superdisintegrants, flavorings, and binders, demanding high-quality raw materials and manufacturing expertise to meet regulatory standards.
Key Global Suppliers of Raw Materials for Tascenso ODT
1. Mannitol and Superdisintegrants Suppliers
Mannitol, a commonly used excipient in ODT formulations, provides the sweetness and mouthfeel desirable for patient acceptance. Major suppliers include Roquette and Evonik Industries, both recognized for their high-purity pharmaceutical-grade Mannitol and disintegrants like croscarmellose sodium.
- Roquette: Supplies pharmaceutical-grade Mannitol and co-processed excipients vital for ODT formulations. Its consistent supply chain and adherence to cGMP standards make it a preferred choice for OEMs manufacturing Tascenso ODT [1].
- Evonik Industries: Offers cross-linked cellulose derivatives such as crosspovidone, critical for superdisintegrant roles in ODTs, ensuring rapid disintegration properties are maintained.
2. Flavors and Sweeteners
Flavor profiles significantly influence patient acceptance of Tascenso ODTs, especially in pediatric applications.
- Givaudan and Firmenich: Leading providers of pharmaceutical-grade flavors tailored for ODT formulations, offering taste-masking solutions compatible with active pharmaceutical ingredients (APIs).
- Sweetener Providers: Companies like PureCircle supply high-quality stevia derivatives, while Ingredient Online offers artificial sweeteners like sucralose, both vital for formulation palatability.
Leading Contract Manufacturing Organizations (CMOs) for Tascenso ODT Production
3. Patheon (Thermo Fisher Scientific)
A prominent global CMO with extensive experience in solid oral dosage forms, Patheon operates multiple facilities compliant with cGMP standards. They possess dedicated ODT production lines capable of formulation customization, scale-up, and packaging.
4. Catalent Pharma Solutions
Known for flexible manufacturing capabilities, Catalent specializes in fast-turnaround ODT production with validated processes for rapid formulation development and commercial manufacturing, ensuring consistency in disintegration time and bioavailability.
5. Recipharm
With established facilities across Europe and North America, Recipharm offers comprehensive end-to-end manufacturing services for ODTs, including stability testing, process development, and commercial production.
6. Siegfried Holding AG
This Swiss-based CDMO provides cold-chain manufacturing and formulation services for complex ODT products, emphasizing high-quality standards for sensitive APIs incorporated into Tascenso ODT.
7. Ajinomoto Bio-Pharma Services
Specializes in biopharmaceuticals but also provides solid dose manufacturing services, including ODT production, with an emphasis on regulatory compliance and quality assurance.
Regional and Local Suppliers
8. India and China as Supply Hubs
India's pharmaceutical sector, led by companies like Aarti Industries and Sun Pharmaceutical Industries, supplies excipients such as disintegrants, binders, and flavoring agents at competitive prices.
Similarly, China’s raw material sector, including Jinan Haidi New Material Co., Ltd., supplies pharmaceutical-grade excipients and packaging solutions, enabling cost-optimized manufacturing of Tascenso ODT.
9. European Suppliers
European regulators emphasizing strict quality standards have fostered a robust network of excipient providers like BASF and Sigma-Aldrich, offering high-purity materials for ODT formulations compatible with stringent regulatory regimes.
Regulatory Considerations and Impact on Supplier Selection
Compliance with the U.S. Food and Drug Administration (FDA) and EudraLex (European Medicines Agency standards) is non-negotiable for Tascenso ODT supplies. Suppliers must provide Certificates of Analysis (CoA), Good Manufacturing Practice (GMP) certifications, and, where applicable, process validation documentation.
Manufacturers should prioritize suppliers with proven compliance histories, audit-ready facilities, and robust Quality Control (QC) frameworks. The choice of supplier can directly influence regulatory approvals, product launch timelines, and market access.
Emerging Trends in Tascenso ODT Supply Chain
- Vertical Integration: Some pharmaceutical majors are integrating upstream to control excipient sourcing, ensuring formulation consistency and supply security for Tascenso ODT.
- Sustainable and Green Sourcing: Growing emphasis on eco-friendly excipient manufacturing prompts suppliers to adopt sustainable practices, influencing procurement decisions.
- Digital Transparency and Traceability: Use of blockchain for raw material provenance enhances trust and regulatory compliance across the supply chain.
Summary and Strategic Recommendations
To ensure a reliable supply of Tascenso ODT, companies should construct a diversified supplier portfolio, balancing global CMOs with specialized raw material vendors. Establishing long-term partnerships with suppliers holding strong regulatory credentials minimizes compliance risk. Incorporating regional suppliers mitigates geopolitical and supply chain disruptions while optimizing costs.
Engaging with suppliers early during formulation development ensures co-innovation and rapid scale-up. Continuous monitoring of supplier performance through audits, quality metrics, and regulatory status updates enhances supply chain resilience.
Key Takeaways
- Global CMOs like Patheon, Catalent, and Recipharm are key partners for large-scale Tascenso ODT manufacturing, offering proven expertise and regulatory compliance.
- Raw material suppliers such as Roquette, Evonik, Givaudan, and standalone regional providers supply critical excipients and flavors, with quality and regulatory standards paramount.
- Regional suppliers in India and China provide cost-effective raw materials, but require rigorous qualification and quality assurance processes.
- Regulatory compliance remains central; supplier qualification should include GMP certification, audits, and transparent documentation.
- Emerging trends favor sustainable sourcing and supply chain digitalization to enhance reliability and regulatory alignment.
FAQs
1. What are the key factors in selecting suppliers for Tascenso ODT production?
Quality compliance, regulatory certifications, supply reliability, cost-effectiveness, and supplier reputation are critical factors.
2. How do regional suppliers impact the supply chain for Tascenso ODT?
They can lower costs and offer supply flexibility but require thorough qualification to ensure quality aligns with regulatory standards.
3. Are there specific challenges in sourcing excipients for ODT formulations?
Yes. Excipient purity, batch-to-batch consistency, and excipient compatibility with APIs are essential considerations.
4. What regulatory concerns should manufacturers consider when choosing Tascenso ODT suppliers?
Manufacturers must verify GMP compliance, audit reports, CoA, and adherence to regional regulatory standards like FDA and EMA.
5. How is sustainability influencing supplier choices for Tascenso ODT?
Preference is shifting toward suppliers committed to eco-friendly manufacturing practices, sourcing renewable materials, and reducing environmental impact.
References
[1] Roquette Freres. Pharmaceutical Excipients. Available at: Roquette Website.
More… ↓
