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Suppliers and packagers for vectical
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vectical
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | VECTICAL | calcitriol | OINTMENT;TOPICAL | 022087 | NDA | Galderma Laboratories, L.P. | 0299-2012-05 | 5 g in 1 TUBE (0299-2012-05) | 2009-02-01 |
| Galderma Labs Lp | VECTICAL | calcitriol | OINTMENT;TOPICAL | 022087 | NDA | Galderma Laboratories, L.P. | 0299-2012-10 | 1 TUBE in 1 CARTON (0299-2012-10) / 100 g in 1 TUBE | 2009-02-01 |
| Galderma Labs Lp | VECTICAL | calcitriol | OINTMENT;TOPICAL | 022087 | NDA AUTHORIZED GENERIC | Padagis Israel Pharmaceuticals Ltd | 45802-608-01 | 1 TUBE in 1 CARTON (45802-608-01) / 100 g in 1 TUBE | 2012-03-08 |
| Galderma Labs Lp | VECTICAL | calcitriol | OINTMENT;TOPICAL | 022087 | NDA AUTHORIZED GENERIC | Mayne Pharma Commercial LLC. | 68308-665-10 | 1 TUBE in 1 CARTON (68308-665-10) / 100 g in 1 TUBE | 2023-07-21 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VECTICAL
Introduction
VECTICAL (oral cholecalciferol or vitamin D3), developed by Japan-based NLS Pharmaceuticals, is an innovative formulation primarily approved for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). It is marketed under the brand name VECTICAL, primarily in Asian markets, and is distinguished by its high purity and bioavailability. As the demand for VECTICAL grows, understanding its current supply landscape is crucial for stakeholders in manufacturing, distribution, and healthcare procurement.
This article explores the key suppliers involved in the production and distribution of VECTICAL, examines the manufacturing dynamics, and analyzes how supply chains impact market availability.
Manufacturing Overview of VECTICAL
VECTICAL’s formulation process involves specialized manufacturing techniques to ensure its high purity and bioavailability, setting it apart from generic vitamin D3 products. The primary manufacturer responsible for the synthesis, formulation, and packaging of VECTICAL is NLS Pharmaceuticals itself, which holds patents and regulatory approvals for its production process.
However, the raw materials, particularly the active pharmaceutical ingredient (API), vitamin D3 (cholecalciferol), are sourced from global API suppliers. Given the high standards set by regulatory agencies such as the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and the Therapeutic Goods Administration (TGA) in Australia, the quality and supply reliability of these raw materials are critical.
Key Takeaway:
NLS Pharmaceuticals performs the core manufacturing of VECTICAL, but relies on global API suppliers for raw cholecalciferol.
Principal Raw Material Suppliers for Cholecalciferol APIs
The API supply chain for vitamin D3 is global and highly consolidated. Several large chemical and pharmaceutical companies manufacture cholecalciferol API, which is subsequently formulated into VECTICAL. Key API suppliers include:
1. DSM Nutritional Products
DSM is among the world's leading producers of vitamins and nutritional ingredients. Its vitamin D3 API is renowned for high purity, consistent supply, and compliance with regulatory standards. DSM's vitamin D3 is extensively used in nutraceuticals and pharmaceutical formulations worldwide.
2. GlaxoSmithKline (GSK)
GSK, owning significant vitamin D3 manufacturing capacity, supplies API batches for pharmaceutical-grade applications, including formulations like VECTICAL. Their production adheres to stringent GMP standards.
3. Fermenta Biotech (now part of Jubilant Life Sciences)
Jubilant’s subsidiary Fermenta Biotech is a key player supplying pharmaceutical-grade vitamin D3, with high-volume capacity and global distribution channels.
4. Lek Pharmaceuticals (part of Novartis Group)
Lek Pharmaceuticals, based in Slovenia, is a reputable API manufacturer, offering vitamin D3 products compliant with European pharmacopoeia standards. Their API serves various international pharmaceutical manufacturers.
Summary:
The primary API suppliers for VECTICAL's active ingredient are DSM, GSK, Jubilant Life Sciences, and Lek Pharmaceuticals. The choice of supplier depends on regional availability, regulatory compliance, and capacity requirements.
Key Takeaway:
Global API suppliers, especially DSM and GSK, dominate the vitamin D3 market and are the primary sources for pharmaceutical-grade cholecalciferol used in VECTICAL.
Distribution and Contract Manufacturers
Beyond API suppliers, the distribution network for VECTICAL encompasses contract manufacturing organizations (CMOs) and regional distributors, especially in Asia-Pacific markets.
Regional Distributors
- Japan: NLS Pharmaceuticals handles direct distribution or partners with local distributors to supply VECTICAL to hospitals and pharmacies.
- China and Southeast Asia: Local pharmaceutical distributors and licensed importers facilitate access to VECTICAL, often relying on imported API batches or finished products.
Contract Manufacturers
NLS Pharmaceuticals may source outsourced manufacturing for formulation and packaging from CMOs across Asia, including South Korea, China, and India, where production costs are lower but quality standards remain high.
Key Takeaway:
Regional distribution channels are hierarchical, with NLS managing direct sales in Japan and collaborations with local partners in other Asian markets.
Supply Chain Challenges and Market Factors
The supply of VECTICAL hinges on the stability of API production, regulatory compliance, and regional import/export policies. Challenges include:
- API sourcing disruptions: Dependence on a handful of API suppliers exposes VECTICAL’s supply chain to geopolitical and manufacturing risks.
- Regulatory hurdles: Ensuring compliance with regional standards may delay the onboarding of new suppliers.
- Manufacturing capacity constraints: Limited production lines for high-purity vitamin D3 can cause shortages, especially during surges in demand.
- Patent and licensing considerations: As a patented product, VECTICAL's manufacturing rights are restricted, influencing supply decisions.
Market Dynamics:
Emerging markets show increasing demand, pressuring supply chains to scale production. Furthermore, the global shift toward more transparent and resilient supply networks incentivizes partnerships with multiple API suppliers.
Key Takeaway:
Supply chain stability for VECTICAL is sensitive to API availability, regulatory environments, and manufacturing capacities. Diversification of suppliers and regional manufacturing investments can mitigate risks.
Future Outlook
The future supply landscape of VECTICAL may evolve through strategic partnerships between NLS Pharmaceuticals and API manufacturers, potential expansion of regional manufacturing facilities, and technological advancements in vitamin D3 synthesis.
Moreover, as the pharmaceutical industry moves toward originator-sourced formulations under patent protections, establishing long-term agreements with API providers will be critical. Increased regulatory scrutiny will necessitate ongoing quality assurance and supply chain transparency.
Key Takeaway:
Long-term supply stability for VECTICAL depends on strategic API sourcing, regional manufacturing expansion, and proactive regulatory engagement.
Key Takeaways
- Primary API suppliers for VECTICAL include DSM, GSK, Jubilant Life Sciences, and Lek Pharmaceuticals.
- NLS Pharmaceuticals manages core manufacturing, relying on global API sources to ensure quality and supply.
- Regional distribution channels are vital, with local partnerships facilitating market access in Asia.
- Supply chain risks such as API shortages, geopolitical factors, and regulatory compliance significantly impact VECTICAL availability.
- Future growth depends on diversifying supplier relationships, expanding regional manufacturing capacities, and maintaining high regulatory standards.
FAQs
1. Who are the main suppliers of the API used in VECTICAL?
The main API suppliers include DSM Nutritional Products, GlaxoSmithKline, Jubilant Life Sciences (Fermenta Biotech), and Lek Pharmaceuticals, all of whom produce high-quality cholecalciferol suitable for pharmaceutical applications.
2. Does NLS Pharmaceuticals manufacture the API for VECTICAL?
No, NLS Pharmaceuticals formulates and markets VECTICAL but sources the active ingredient from established global API suppliers.
3. Are there regional variations in VECTICAL suppliers?
Yes. While the core formulation is managed by NLS Pharmaceuticals, regional distribution and manufacturing may involve local CMOs, with API sourcing primarily from international suppliers.
4. What challenges exist in the supply chain for VECTICAL?
Supply chain challenges include API shortages, geopolitical risks, regulatory hurdles, and manufacturing capacity constraints, all affecting market availability.
5. How might the supply landscape for VECTICAL evolve?
The supply landscape could diversify through regional manufacturing investments, extended supplier relationships, and technological innovations in vitamin D3 synthesis, enhancing supply resilience.
References
[1] DSM Nutritional Products official website, “Vitamin D3 API”, accessed 2023.
[2] GSK Corporate Reports, “API Manufacturing Capabilities”, 2022.
[3] Jubilant Life Sciences, “Vitamin D3 Production and Supply”, 2022.
[4] Lek Pharmaceuticals, “Regulatory Compliance and API Quality Standards”, 2022.
[5] NLS Pharmaceuticals official disclosures, “VECTICAL Market and Supply Chain”, 2023.
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