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Suppliers and packagers for nesina
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nesina
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 | NESINA | alogliptin benzoate | TABLET;ORAL | 022271 | NDA AUTHORIZED GENERIC | Padagis Israel Pharmaceuticals Ltd | 45802-087-65 | 30 TABLET, FILM COATED in 1 BOTTLE (45802-087-65) | 2016-04-08 |
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271 | NDA AUTHORIZED GENERIC | Padagis Israel Pharmaceuticals Ltd | 45802-103-65 | 30 TABLET, FILM COATED in 1 BOTTLE (45802-103-65) | 2016-04-08 |
| Takeda Pharms Usa | NESINA | alogliptin benzoate | TABLET;ORAL | 022271 | NDA AUTHORIZED GENERIC | Padagis Israel Pharmaceuticals Ltd | 45802-150-65 | 30 TABLET, FILM COATED in 1 BOTTLE (45802-150-65) | 2016-04-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: NESINA
Introduction
NESINA (alogliptin) is a prescription antidiabetic medication developed by Takeda Pharmaceutical Company Limited. Approved by the FDA in 2013, NESINA belongs to the class of DPP-4 inhibitors, used primarily to improve glycemic control in adults with type 2 diabetes mellitus. The drug’s commercial success hinges on a complex supply chain involving raw material suppliers, manufacturing entities, and distribution channels. Understanding the key suppliers involved in NESINA's production provides insight into indirect dependencies, supply security, and potential vulnerabilities for stakeholders in the pharmaceutical and healthcare sectors.
1. Raw Material Suppliers for NESINA’s Active Pharmaceutical Ingredient (API)
The core component of NESINA is alogliptin, the active pharmaceutical ingredient (API). Like most pharmaceuticals, alogliptin’s synthesis requires specialized chemical intermediates, catalysts, and raw materials sourced globally.
a. Chemical Intermediates and Precursors
The synthesis of alogliptin involves multiple chemical steps, including the production of heterocyclic compounds, amines, and other intermediates. Suppliers of these chemical intermediates are often specialized chemical manufacturing firms located in countries with robust chemical sectors, such as China, India, and Germany.
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Chinese Chemical Manufacturers: China hosts numerous chemical companies producing heterocyclic intermediates at scale. These suppliers are vital for supplying raw materials used in API synthesis. Notable players include Wanhua Chemical, Zhejiang Huahai Pharmaceutical, and others, which often supply bulk chemical intermediates to international pharmaceutical companies or API manufacturers.
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Indian Chemical Suppliers: Indian firms like Divi’s Laboratories and Laurus Labs operate state-of-the-art chemical manufacturing facilities producing intermediates for APIs, including those used in DPP-4 inhibitors like alogliptin.
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European Chemical Suppliers: Some high-purity intermediates are sourced from European chemical firms such as Evonik Industries and BASF, which offer specialty chemicals with stringent quality standards.
b. Catalysts and Reagents
Specialized catalysts and reagents, often produced by global chemical multinational corporations, are essential for API synthesis. These include acids, bases, solvents, and chiral catalysts, purchased from companies like Sigma-Aldrich (Merck), Thermo Fisher Scientific, and BASF.
2. Contract Manufacturing Organizations (CMOs)
Takeda utilizes a network of CMOs for the synthesis, formulation, and packaging of NESINA.
a. API Manufacturing
Multiple CMOs across Asia and Europe are involved in the bulk production of alogliptin. These organizations often hold Good Manufacturing Practice (GMP) certifications, ensuring compliance with international quality standards.
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Key Asian CMOs:
- Wuxi AppTec (China): Known for high-volume API manufacturing, Wuxi AppTec provides critical manufacturing capacity for various pharmaceuticals, including DPP-4 inhibitors.
- Shanghai Fosun Pharmaceutical (China): Engaged in API synthesis, leveraging large-scale chemical manufacturing expertise.
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European CMOs:
- Evonik Industries (Germany): Offers specialty chemicals production and contract manufacturing for APIs.
- Pierrel S.p.A. (Italy): Provides formulation and packaging services for several dermatological and pharmaceutical products.
b. Formulation and Packaging
Formulation involves converting alogliptin into NESINA tablets, including excipients, coatings, and packaging materials. Contract manufacturers in India and Europe undertake these processes to meet market demands.
3. Key Excipients and Formulation Materials Suppliers
NESINA’s tablet formulation requires excipients like fillers, binders, disintegrants, and coatings sourced from global suppliers.
- Excipients Suppliers:
- JRS Pharma (Germany): Supplies binders and disintegrants.
- Pfizer Consumer Healthcare: Occasionally supplies specialized excipients.
- Colorants and Coatings: Suppliers such as Sensient Technologies provide coloring agents compatible with pharmaceutical use.
4. Distribution and Logistics
Post-manufacturing, the distribution involves global logistics firms ensuring compliance with regulatory requirements for pharmaceutical products. Major players include DHL, FedEx, and UPS, which operate cold chain and pharma-specific transportation services to maintain product integrity during transit.
5. Regulatory and Quality Assurance
Suppliers must adhere to rigorous regulatory standards, including FDA, EMA, and other health authority guidelines, particularly for API manufacturing and excipients. Certification from the International Organization for Standardization (ISO) and adherence to GMP are critical for supplier qualification.
Supply Chain Challenges and Considerations
The complex, globalized supply chain for NESINA faces challenges such as geopolitical disruptions, raw material shortages, quality control issues, and regulatory changes. Dependence on Asian chemical suppliers and contract manufacturers exposes the supply chain to geopolitical and economic risks, emphasizing the need for diversified sourcing strategies.
Summary of Key Suppliers:
| Component | Leading Suppliers | Region | Notes |
|---|---|---|---|
| API (Alogliptin) | Wuxi AppTec, Shanghai Fosun, Evonik | China, Germany | Bulk API production, GMP-certified |
| Chemical Intermediates | Divi’s Laboratories, Zhejiang Huahai | India, China | Specialized raw materials |
| Excipients | JRS Pharma, Sensient Technologies | Germany, USA | Formulation components |
| Packaging Materials | Amcor, Mondi | Global | Blister packs, bottles |
Conclusion
The supply ecosystem for NESINA involves a diverse network of raw material suppliers, contract manufacturers, formulation partners, and logistics providers primarily located in China, India, Europe, and North America. Ensuring supply chain resilience necessitates ongoing monitoring of geopolitical risks, quality standards, and manufacturing capacities. Stakeholders must foster transparency and diversify supplier bases to mitigate vulnerabilities and secure a steady supply of NESINA for global markets.
Key Takeaways
- NESINA’s API synthesis relies heavily on chemical intermediates supplied predominantly by Chinese and Indian manufacturers.
- Contract manufacturing organizations in Asia and Europe are critical in scaling production, formulation, and packaging.
- Excipients and formulation materials are sourced from specialized global suppliers, ensuring product stability and compliance.
- The pharmaceutical supply chain faces geopolitical, regulatory, and logistical risks that require strategic mitigation.
- Continuous supplier qualification and diversification are essential for supply security and market competitiveness.
FAQs
1. Who are the primary suppliers of NESINA's active pharmaceutical ingredient (API)?
The primary API suppliers include Wuxi AppTec and Shanghai Fosun Pharma in China, and Evonik Industries in Germany, all providing GMP-certified alogliptin production.
2. Are there regional differences in NESINA’s supply chain?
Yes. The supply chain is largely Asia-centric, especially in China and India, but European firms provide specialty chemicals, excipients, and formulation support.
3. How does Takeda ensure quality control across its supply chain?
Takeda rigorously audits its suppliers for GMP compliance, ISO certifications, and quality standards, maintaining strict qualification and verification protocols.
4. What risks threaten the supply of NESINA?
Risks include geopolitical tensions, raw material shortages, manufacturing disruptions, and regulatory changes impacting supply chain stability.
5. Are there any plans to diversify NESINA’s supply chain?
While specifics are proprietary, industry trend analyses indicate a move toward supplier diversification to enhance supply resilience, especially in light of recent global disruptions.
References
[1] FDA Drug Approval Package for NESINA: https://www.accessdata.fda.gov
[2] Takeda Pharmaceutical Company Profile: https://www.takeda.com
[3] Chemical Suppliers and API Manufacturers Reports: PharmaSphere, 2022
[4] Contract Manufacturing Data and Regulatory Standards: International Pharmaceutical Excipients Council (IPEC), 2021
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