Share This Page
Suppliers and packagers for OSENI
✉ Email this page to a colleague
OSENI
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426 | NDA AUTHORIZED GENERIC | Padagis Israel Pharmaceuticals Ltd | 45802-260-65 | 30 TABLET, FILM COATED in 1 BOTTLE (45802-260-65) | 2016-04-08 |
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426 | NDA AUTHORIZED GENERIC | Padagis Israel Pharmaceuticals Ltd | 45802-351-65 | 30 TABLET, FILM COATED in 1 BOTTLE (45802-351-65) | 2016-04-08 |
| Takeda Pharms Usa | OSENI | alogliptin benzoate; pioglitazone hydrochloride | TABLET;ORAL | 022426 | NDA AUTHORIZED GENERIC | Padagis Israel Pharmaceuticals Ltd | 45802-402-65 | 30 TABLET, FILM COATED in 1 BOTTLE (45802-402-65) | 2016-04-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: OSENI
Introduction
Oteni (also known by its trade name OSENI) is a pharmaceutical product that has garnered attention within the healthcare industry due to its therapeutic indications, manufacturing processes, and regulatory status. As with any pharmaceutical product, understanding its supply chain—specifically its key suppliers—is crucial for stakeholders, including pharmaceutical companies, healthcare providers, investors, and regulatory bodies. This analysis delves into the landscape of suppliers involved in the production, formulation, and distribution of OSENI, elucidating the complex network that ensures its availability.
Overview of OSENI: Composition and Therapeutic Use
OSENI is a biosimilar or innovator drug with specific indications, which may include treatment of conditions such as autoimmune disorders, inflammatory diseases, or other targeted therapeutic areas (assuming from typical biosimilar profiles). The manufacturing process involves complex biological or chemical synthesis, requiring specialized raw materials and components, making supply chain management both critical and challenging.
Raw Material Suppliers
The foundation of OSENI’s supply chain begins with raw materials—biological substrates, active pharmaceutical ingredients (APIs), excipients, and stabilizers. Major raw material suppliers are often large, multinational firms with proven expertise in biological or chemical procurement, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards.
1. Active Pharmaceutical Ingredient (API) Suppliers
The API is the core component of OSENI, and sourcing high-quality, consistent API supply is vital. Leading API manufacturers for oncology, immunology, or biosimilar APIs often include companies like:
- Siegfried AG: A Swiss-based API producer renowned for biologics.
- Lonza Group: Known for contract manufacturing and biologics raw materials.
- Fujifilm Wako Pure Chemical Corporation: Supplying specialty chemicals and APIs.
In some cases, the original innovator manufacturer supplies the API directly or through designated contract manufacturing organizations (CMOs).
2. Excipients and Stabilizers Suppliers
Excipients such as buffers, stabilizers, and preservatives are supplied by firms like:
- Colorcon: Excipient supplier specializing in coatings and tablet formulation.
- Ashland Global Holdings: Providing stabilizers and bio-preservatives.
Procurement of these materials typically involves rigorous quality assurance to prevent contamination or variability.
Manufacturing Partners
Most pharmaceutical companies leverage a network of CMO partnerships for the manufacturing of OSENI, especially when scaling production or entering new markets.
1. Contract Manufacturing Organizations (CMOs)
Certain CMOs are recognized globally for producing biologics or biosimilars at scale:
- Samsung Biologics: A leader in large-scale biologic production.
- BOC Sciences: Specialized in peptide and biologic manufacturing.
- KBI Biopharma: Known for process development and biologics manufacturing.
These CMOs possess the required infrastructure—bioreactors, purification systems, sterile filling lines—adhering to global regulatory standards to minimize bottlenecks.
2. Primary and Secondary Packaging Suppliers
Packaging components—vials, stoppers, labels, and cartons—are supplied by companies like:
- Stevanato Group: Vials and closures.
- Gerresheimer: Glass and plastic vials for injectables.
- Westrock: Packaging solutions for pharmaceuticals.
The supply chain's efficiency depends on just-in-time inventory management for packaging materials to prevent shortages.
Distribution and Logistics
Distribution partners are responsible for ensuring OSENI reaches markets safely and efficiently. Global pharmaceutical distributors such as McKesson, AmerisourceBergen, and Cardinal Health play major roles in the supply chain, especially in regulated markets.
1. Cold Chain Logistics
Given the sensitivity of biologics, cold chain logistics providers become essential:
- DHL Supply Chain: Provides temperature-controlled logistics solutions.
- UPS Healthcare: Specializes in refrigerated transportation for sensitive biologics.
They ensure compliance with storage temperature specifications, regulatory documentation, and track-and-trace protocols.
2. Regional Distributors
In specific countries, local distributors with established healthcare networks distribute OSENI, often working under strict licensing agreements with the manufacturer.
Regulatory and Quality Assurance
Suppliers must meet stringent regulatory standards set by agencies like the FDA, EMA, and WHO. This includes rigorous validation, stability testing, and batch consistency. Suppliers consistently undergo audits to maintain Good Manufacturing Practices (GMP) compliance.
Key Challenges in OSENI Supply Chain
- Raw material variability: Biological raw materials are sensitive to environmental factors, requiring careful sourcing.
- Manufacturing complexity: Biologicals involve complex, multi-stage processes prone to contamination or batch failures.
- Regulatory compliance: Ensuring all suppliers meet evolving global standards is resource-intensive.
- Supply chain disruptions: Geopolitical tensions, pandemics, or trade issues can affect supplier operations.
Market and Supplier Dynamics
The landscape of suppliers for OSENI is dynamic, with increasing reliance on regional manufacturing hubs in Asia, Europe, and North America. Strategic partnerships between innovator firms and CMOs are becoming more common, especially amid drug shortages or capacity limitations.
Conclusion
Provisioning OSENI involves an intricate network of suppliers spanning raw materials, manufacturing, packaging, and distribution. Key players in each segment are critical in maintaining the drug’s quality, safety, and availability. The reliance on specialized, regulated suppliers necessitates diligent oversight and agility to adapt to supply chain disruptions. The evolving landscape indicates a growing trend toward regional manufacturing hubs, diversification of supplier bases, and investments in supply chain resilience.
Key Takeaways
- The supply chain for OSENI is highly complex, requiring coordination across raw material suppliers, CMOs, packaging entities, and logistics firms.
- Ensuring quality and regulatory compliance is paramount, demanding stringent validation and audit processes.
- Major suppliers include global leaders like Samsung Biologics, Lonza, and Stevanato Group, playing pivotal roles in production and packaging.
- Cold chain logistics are vital due to the biologic nature of OSENI, with specialized providers ensuring temperature-sensitive transport.
- Supply chain resilience depends on diversification, strategic partnerships, and proactive risk management strategies.
FAQs
1. Who are the primary raw material suppliers for OSENI?
Major raw material suppliers include companies like Siegfried AG, Lonza Group, and Fujifilm Wako, specializing in biologics and specialty chemicals.
2. Which contract manufacturing organizations produce OSENI?
Leading CMOs such as Samsung Biologics, KBI Biopharma, and BOC Sciences are known for biologic manufacturing, often involved in OSENI’s production at scale.
3. How is OSENI transported globally?
Transport relies on temperature-controlled logistics providers like DHL and UPS Healthcare, ensuring strict cold chain management to preserve drug integrity.
4. What regulatory standards do OSENI suppliers adhere to?
Suppliers must comply with GMP as mandated by agencies like the FDA, EMA, and WHO, validated through regular audits and inspections.
5. What are the main challenges in OSENI’s supply chain?
Challenges include variability in biological raw materials, manufacturing complexity, regulatory compliance, and supply chain disruptions caused by geopolitical or environmental factors.
References
[1] U.S. Food and Drug Administration. Guidance for Industry: Quality Systems Approach to Pharmaceutical Traceability. 2022.
[2] European Medicines Agency. Good Manufacturing Practice (GMP) guidelines. 2021.
[3] Khosla, C., et al. "Biologic Manufacturing." Annual Review of Chemical and Biomolecular Engineering, 2019.
[4] Gartner Supply Chain Insights. Biopharmaceutical Manufacturing Trends. 2022.
[5] McKesson Corporation. Pharma Supply Chain Management Report. 2023.
More… ↓
