Share This Page
Suppliers and packagers for KERENDIA
✉ Email this page to a colleague
KERENDIA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | KERENDIA | finerenone | TABLET;ORAL | 215341 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-540-01 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-01) | 2021-07-09 |
| Bayer Hlthcare | KERENDIA | finerenone | TABLET;ORAL | 215341 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-540-02 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-540-02) | 2021-07-09 |
| Bayer Hlthcare | KERENDIA | finerenone | TABLET;ORAL | 215341 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-540-06 | 10 TABLET, FILM COATED in 1 BLISTER PACK (50419-540-06) | 2021-07-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Kerendia
Introduction
Kerendia (brand name of the active pharmaceutical ingredient finerenone) is a prescription medication developed by Bayer for the management of chronic kidney disease (CKD) associated with type 2 diabetes. As a selective non-steroidal mineralocorticoid receptor antagonist (MRA), Kerendia has gained prominence as a novel therapeutic option. The pharmaceutical supply chain for Kerendia involves multiple suppliers engaged across various stages, including active pharmaceutical ingredient (API) manufacturing, formulation, packaging, and distribution. This article provides a comprehensive overview of the key suppliers involved in Kerendia’s manufacturing ecosystem, analyzing their roles, capacities, and strategic positioning within the global pharmaceutical supply chain.
Active Pharmaceutical Ingredient (API) Suppliers
At the core of Kerendia's manufacturing process lies the synthesis of finerenone, the active ingredient. The API suppliers are pivotal in ensuring the quality, purity, and supply stability essential for pharmaceutical manufacturing compliance.
Bayer's Direct API Manufacturing
Bayer, as the innovative developer of Kerendia, retains close oversight of the API production process. The company employs a combination of internal manufacturing facilities and contracted manufacturing organizations (CMOs) to produce finerenone. Bayer’s own facilities are equipped to maintain strict quality standards aligned with Good Manufacturing Practices (GMP), ensuring regulatory compliance across markets.
Contracted API Manufacturers
While Bayer's internal manufacturing plays a central role, the complexity and specificity of finerenone synthesis necessitate collaboration with specialized CMOs. Several key players are known to serve as API suppliers or contract manufacturers for finerenone, although specific supplier identities often remain proprietary. Industry sources suggest that Bayer partners with CMOs with advanced synthetic chemistry capabilities, particularly those experienced in complex heterocyclic compound synthesis, which is characteristic of finerenone's molecular structure.
Global API Production Landscape
Given the relatively recent market approval of Kerendia (approved by the FDA in July 2021), the supply chain for finerenone is still establishing its robustness. However, emerging reports indicate that Asian contract manufacturing firms, particularly in India and China, are increasingly involved in pharmaceutical API production, including specialized molecules like finerenone[1].
Implications for Supply Chain Stability
Dependence on global API suppliers underscores inherent supply risks. Potential disruptions arising from geopolitical issues, manufacturing capacity constraints, or regulatory hurdles could impact Kerendia’s availability. Accordingly, Bayer’s strategic partnerships with multiple API suppliers or raw material vendors help mitigate risks.
Formulation and Finished Dosage Form Suppliers
Once the API is synthesized, it undergoes formulation into the final oral tablet form. The manufacturing process involves blending, compression, coating, quality control, and packaging.
Manufacturers of Finished Kerendia Tablets
Bayer operates its own formulation facilities, meticulously controlled to uphold GMP standards. The formulation process involves blending finerenone with excipients such as fillers, binders, disintegrants, and coatings optimized for bioavailability and stability.
In addition, Bayer may collaborate with third-party contract manufacturing organizations (CMOs) globally, particularly in regions with high manufacturing capacity such as India, Europe, and North America. These CMOs are responsible for large-scale production, adhering to strict quality protocols.
Packaging and Distribution Suppliers
Post-formulation, the medication is packaged in blister packs or bottles, depending on regional regulations. Packaging suppliers for pharmaceutical companies often include specialized firms capable of producing child-resistant, tamper-evident packaging with detailed labeling. Distributors and logistics providers—ranging from Bayer’s internal supply chain teams to third-party logistics firms—ensure timely delivery across various markets.
Raw Material and Excipient Suppliers
Beyond the primary ingredients, the production of Kerendia tablets depends on high-quality excipients and raw materials.
Excipients Suppliers
Excipients such as microcrystalline cellulose, lactose, and coatings are sourced from global suppliers. Major excipient manufacturers such as FMC Corporation, Meggle AG, and JRS Pharma are known to supply excipients to pharmaceutical companies worldwide. These companies rigorously test and validate excipients to confirm their suitability for pharmaceutical manufacturing.
Raw Material Vendors
The synthesis of finerenone involves complex organic chemistry, requiring specific reagents and solvents. Suppliers of high-purity chemicals, such as Merck KGaA, Sigma-Aldrich (a division of Merck), and Thermo Fisher Scientific are commonly involved in providing analytical-grade reagents crucial for API synthesis.
Distribution and Supply Chain Partners
Effective distribution channels ensure Kerendia reaches pharmacies and hospitals globally. Bayer’s distribution network includes licensed wholesalers, authorized distributors, and regional logistics providers that facilitate supply chain resilience.
Third-Party Logistics Providers
Logistics firms such as DHL, FedEx, and other specialized pharmaceutical carriers manage temperature-controlled and time-sensitive shipments. They coordinate regulatory clearance, customs, and local distribution to maintain supply chain continuity.
Regulatory and Quality Standards for Suppliers
All suppliers involved in Kerendia’s supply chain must comply with stringent regulatory standards. These include:
- Good Manufacturing Practices (GMP): Ensured by regulatory agencies like the FDA, EMA, and respective local authorities.
- ISO Certifications: ISO 9001, ISO 14001, and other relevant standards reinforce quality and environmental management.
- Pharmacopoeial Standards: API and excipients must meet pharmacopoeial specifications (e.g., USP, EP, BP).
Regular audits and supplier qualification processes are integral to Bayer’s supply network management, ensuring ongoing compliance and quality assurance.
Supply Chain Challenges and Mitigation Strategies
The global pharmaceutical supply chain faces challenges including geopolitical tensions, raw material shortages, manufacturing capacity constraints, and regulatory delays. To mitigate these risks, Bayer and its suppliers employ strategies such as:
- Establishing multiple sourcing options for critical raw materials and API.
- Investing in regional manufacturing hubs to diversify supply bases.
- Implementing advanced forecasting and inventory management systems.
- Maintaining strategic stockpiles, particularly for API and key excipients.
Conclusion
The supply chain for Kerendia is complex, involving a mix of internally controlled manufacturing processes and external specialized suppliers. Bayer's strategic collaborations with API manufacturers, formulation and packaging CMOs, excipient suppliers, and logistics providers create a resilient ecosystem capable of supporting global demand. Continuous supplier qualification, diversification, and adherence to high regulatory standards remain essential to securing the drug’s supply in an evolving pharmaceutical landscape.
Key Takeaways
- The core API, finerenone, is produced by Bayer’s internal facilities and contracted CMOs, primarily in Asia and Europe.
- Formulation, packaging, and finished drug distribution involve both Bayer’s own operations and regional CMOs, emphasizing a diversified supply network.
- Excipients and raw materials are sourced globally from established chemical and pharmaceutical suppliers adhering to strict quality standards.
- Supply chain resilience hinges on multi-sourcing strategies, regional manufacturing investments, and compliance with regulatory standards.
- Ongoing geopolitical, regulatory, and market factors necessitate agile supply chain management to ensure consistent Kerendia availability.
FAQs
1. Who are the primary API suppliers for Kerendia?
Bayer manufactures finerenone in-house and collaborates with specialized CMOs, predominantly in Asia and Europe. Specific supplier identities are proprietary, but Asian CMOs are increasingly involved.
2. Are there alternative suppliers for Kerendia's excipients?
Yes. Major excipient manufacturers like FMC Corporation and JRS Pharma supply high-grade excipients globally, ensuring supply continuity.
3. How does Bayer ensure supply chain quality for Kerendia?
Through rigorous qualification processes, adherence to GMP, regular audits, and dual sourcing strategies for critical components.
4. What risks could disrupt Kerendia's supply chain?
Potential risks include geopolitical tensions, raw material shortages, manufacturing delays, and regulatory hurdles. Bayer mitigates these with diversification and regional manufacturing.
5. Are there regional differences in Kerendia supply chain strategies?
Yes. Bayer adapts its supply chain based on regional demand, regulatory environment, and manufacturing capacity, with investments in regional facilities to support local distribution.
References
[1] Industry reports and market analyses indicate increasing API manufacturing activity in India and China, particularly for complex molecules.
More… ↓
