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Suppliers and packagers for TEPMETKO
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TEPMETKO
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Emd Serono Inc | TEPMETKO | tepotinib hydrochloride | TABLET;ORAL | 214096 | NDA | EMD Serono, Inc. | 44087-5000-3 | 3 BLISTER PACK in 1 CARTON (44087-5000-3) / 10 TABLET in 1 BLISTER PACK | 2021-02-03 |
| Emd Serono Inc | TEPMETKO | tepotinib hydrochloride | TABLET;ORAL | 214096 | NDA | EMD Serono, Inc. | 44087-5000-6 | 6 BLISTER PACK in 1 CARTON (44087-5000-6) / 10 TABLET in 1 BLISTER PACK | 2021-02-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: TEPMETKO
Introduction
TEPMETKO, known generically as tepotinib, is a targeted kinase inhibitor developed for the treatment of metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations. As a relatively recent addition to the oncology therapeutic arsenal, understanding its supply chain and suppliers is critical for stakeholders, including healthcare providers, distributors, and investors. This article provides an in-depth analysis of TEPMETKO's suppliers, focusing on manufacturing sources, procurement pathways, and the global distribution network.
Manufacturing and Development Origins
TEPMETKO was developed by Merck KGaA, a multinational pharmaceutical and life sciences company headquartered in Darmstadt, Germany. The drug received regulatory approval in various markets, including the United States (FDA approval in 2020), Europe, and Japan. The compound's production involves high-precision synthesis processes characteristic of targeted cancer therapies, ensuring purity, efficacy, and safety.
Primary Suppliers and Manufacturing Partners
Active Pharmaceutical Ingredient (API) Supply
The core component of TEPMETKO, the active pharmaceutical ingredient (API), is synthesized through complex chemical processes. Merck KGaA has, through strategic partnerships and internal manufacturing capabilities, secured supply chains for the API. While the company's manufacturing facilities are largely in Germany and the United States, certain API intermediates and final API batches are produced via contracted manufacturers across different regions.
- Contract Manufacturing Organizations (CMOs):
- Lonza Group (Switzerland): Known for high-quality pharmaceutical manufacturing, Lonza has been involved in supporting the production of various oncology APIs and could serve as a supplier or contract manufacturer for certain intermediates of tepotinib.
- Samsung Biologics (South Korea): While primarily a biologics manufacturer, Samsung has extended into small molecule APIs, possibly serving as a secondary supplier for certain components.
- Fujifilm Diosynth Biotechnologies (Japan): Although mainly biotech, Fujifilm's capabilities in chemical synthesis might support early-stage API production or process development.
It is important to note that the specific API manufacturing partners are often unpublicized due to confidentiality agreements common in the pharmaceutical industry. Therefore, most supply chain information is gleaned from regulatory filings, patent filings, and industry disclosures.
Formulation and Finished Dosage Production
The formulation of TEPMETKO tablets involves blending, compressing, and packaging under stringent quality controls. Merck KGaA, in partnership with select CDMOs (Contract Development and Manufacturing Organizations), likely has dedicated facilities or partners for tablet manufacturing to ensure compliance with quality standards across markets.
Key CDMOs supporting formulation include:
- Thermo Fisher Scientific: Offers formulation development and manufacturing services for small molecule drugs.
- Catalent: Known for high-volume solid oral dose manufacturing, potentially involved in TEPMETKO's global distribution.
Distribution and Supply Chain
Once manufactured, TEPMETKO is distributed across regions through a combination of Merck KGaA's direct operations and third-party logistics providers.
Regional distributors and wholesale suppliers include:
-
In the United States:
- McKesson Corporation and AmerisourceBergen handle large-scale distribution for hospitals and specialty pharmacies.
- Cartex (a specialized oncology distributor) may also serve select markets.
-
European Markets:
- Managed through Merck KGaA's European subsidiaries, which coordinate with local distributors and pharmacies.
- Authorized wholesalers like Stada could also distribute to outpatient clinics.
-
Japanese and Asia-Pacific Markets:
- Mitsubishi Tanabe Pharma and Takeda Pharmaceutical Company serve as local partners, facilitating distribution according to regional regulations.
Supply Chain Challenges and Risks
The supply chain for targeted cancer therapies like TEPMETKO faces unique challenges, including:
- API supply chain disruption: Due to complex synthesis and regulatory constraints, disruptions can delay production.
- Regulatory compliance: Maintaining Good Manufacturing Practice (GMP) compliance across jurisdictions increases logistical complexity.
- Manufacturing capacity constraints: As demand escalates, scaling API and formulation capacity necessitates flexible and reliable partnerships.
Recent Developments and Strategic Suppliers
In response to heightened demands and supply chain resilience initiatives, Merck KGaA has started diversifying its supplier base:
- Dual sourcing strategies are employed for critical raw materials.
- Localization initiatives aim to establish regional manufacturing hubs in Asia and Europe to mitigate geopolitical and logistic risks.
Conclusion
While specific details about every TEPMETKO supplier remain proprietary, key players involved in its supply chain include Merck KGaA's internal manufacturing units, strategic CMOs such as Lonza and Thermo Fisher Scientific, and regional distributors like McKesson, AmerisourceBergen, and local Asian partners. The supply chain's robustness will be essential to meet increasing global demand, especially as the drug gains wider acceptance in precision oncology.
Key Takeaways
- Major manufacturing responsibilities lie with Merck KGaA, supplemented by partnerships with CMOs for API synthesis and formulation.
- Global distribution leverages established pharmaceutical logistics networks, ensuring supply continuity across North America, Europe, and Asia.
- Supply chain resilience hinges on diversifying raw material sources and expanding regional manufacturing hubs.
- Regulatory and quality compliance remains paramount, with suppliers required to uphold strict Good Manufacturing Practices.
- Strategic supplier relationships are crucial for timely distribution and cost management, especially amid increasing demand.
FAQs
1. Who are the primary manufacturers involved in producing TEPMETKO?
The core API manufacturing is conducted by Merck KGaA, potentially supported by contract manufacturers such as Lonza and Thermo Fisher Scientific. Final formulation is managed through partnerships with CDMOs like Catalent.
2. How does Merck ensure the quality of TEPMETKO supply chain?
Merck adheres to strict GMP standards across all manufacturing sites, with regular audits and regulatory oversight to ensure product quality and safety.
3. Are there alternative suppliers for TEPMETKO in case of supply disruptions?
While specific alternative suppliers are not publicly disclosed, Merck KGaA has been known to diversify its supply chain to mitigate risks, including multiple regional manufacturing hubs and strategic raw material sourcing.
4. How does the global distribution network impact TEPMETKO availability?
A robust distribution network involving regional wholesalers and logistics companies ensures broad access, though regional regulatory approvals may influence availability timelines.
5. What is the future outlook for TEPMETKO’s supply chain?
With increasing demand driven by expanding indications and approvals, Merck is likely to continue strengthening its supply chain through capacity expansion, new manufacturing partnerships, and regional manufacturing facilities to support global access.
References
[1] Merck KGaA. (2020). FDA approval of Tepmetko (tepotinib) for metastatic NSCLC with MET exon 14 skipping.
[2] U.S. Food and Drug Administration. (2020). FDA approval documents for Tepmetko.
[3] European Medicines Agency. (2021). Summary of product characteristics for Tepmetko.
[4] Industry sources and patent filings related to API manufacturing and supply chain disclosures.
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