Suppliers and packagers for generic pharmaceutical drug: TEPOTINIB HYDROCHLORIDE

TEPOTINIB HYDROCHLORIDE

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

Last updated: July 30, 2025

ppliers for the Pharmaceutical Drug: Tepotinib Hydrochloride

Overview of Tepotinib Hydrochloride

Tepotinib hydrochloride is an innovative targeted therapy primarily used to treat non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutations. Developed by Merck KGaA (EMD Serono in some markets), Tepotinib (brand name Tepmetko) belongs to the class of MET inhibitors—critical in oncological treatments targeting MET gene alterations. As an orphan drug approved by the U.S. FDA and EMA, its production and supply chain management are vital for global patient access.

This article explores the key suppliers involved in the manufacturing, sourcing, and distribution of Tepotinib hydrochloride, providing insights into their roles, market dynamics, and strategic considerations for healthcare providers and pharmaceutical industry stakeholders.

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Manufacturers of Tepotinib Hydrochloride

1. Merck KGaA / EMD Serono

As the originator and patent holder of Tepotinib, Merck KGaA is the primary supplier of the active pharmaceutical ingredient (API) and finished dosage forms in markets where the drug is approved. The company's integrated manufacturing facilities in Europe and North America ensure the supply of high-quality tepotinib hydrochloride.

Merck's vertical integration encompasses API synthesis, formulation, and packaging, ensuring supply chain stability. Their robust R&D pipeline and manufacturing network facilitate continuous production and capacity expansion to meet global demand.

2. Contract Manufacturing Organizations (CMOs)

Given the high standards required for oncology therapeutics, Merck collaborates with several CMOs specializing in complex small-molecule synthesis and pharmaceutical-grade API production. Leading CMO partners include:

• Fujifilm Diosynth Biotechnologies: Known for its expertise in chemical synthesis and cGMP compliance, Fujifilm supplies APIs for various small-molecule drugs, potentially including tepotinib hydrochloride.

• Thermo Fisher Scientific: Offers API development and manufacturing services. In some cases, Pharma companies outsource manufacturing to Thermo Fisher for capacity augmentation.

• Boehringer Ingelheim: A prominent CMO in active pharmaceutical ingredient production, with capabilities aligned for small-molecule kinase inhibitors such as tepotinib.

While exact contractual relationships are not publicly disclosed, these organizations are integral to the supply chain for Tepotinib hydrochloride.

3. API Ingredient Suppliers

Apart from final manufacturers, certain chemical suppliers provide the precursor molecules and intermediates necessary for tepotinib hydrochloride synthesis. These suppliers are usually based in China, India, and Europe, known for their large-scale chemical manufacturing capabilities.

Companies such as:

• Shandong Xinhua Pharmaceutical
• Sinochem
• Lanxess

are notable providers of advanced intermediates and specialty chemicals, potentially supplying raw materials for tepotinib synthesis, subject to regulatory and quality compliance.

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Distribution and Supply Chain Dynamics

Global Distribution Channels

Tepotinib's commercial availability depends on consistent supply chain logistics encompassing warehouse storage, cold chain management, and distribution to hospitals, clinics, and pharmacy networks. The supply chain is highly regulated, with strict adherence to cGMP standards to prevent contamination and ensure potency.

Regional Manufacturers and Generic Entrants

Pending patent expirations and biosimilar developments, regional manufacturers in India and China are increasingly capable of producing generic versions or biosimilar formulations, potentially sourcing API from licensed suppliers or developing in-house synthesis. These entrants are crucial in expanding access, especially in emerging markets.

Supply Chain Challenges

• Regulatory Compliance: Ensuring API and finished product meet varying regional regulatory standards (FDA, EMA, PMDA, etc.)
• Production Capacity: Scaling manufacturing to match rising demand without compromising quality standards
• Supply Disruptions: Risks from geopolitical conflicts, pandemic-related logistics issues, and raw material shortages

Strategies for Stakeholders

Pharmaceutical supply chain resilience necessitates diversified sourcing, establishing multiple supplier relationships, and building safety stocks. Manufacturers should also focus on technological advancements in synthesis and formulation to streamline production.

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Emerging Trends and Future Outlook

1. Expansion of Geographical Sourcing

As the demand for Tepotinib increases globally, especially in Asia-Pacific, local manufacturing facilities in developing regions are emerging as key suppliers, driven by regional regulatory approvals and cost efficiencies.

2. Development of Biosimilars and Generics

While Tepotinib's patent exclusivity ensures initial high margins, patent expirations or licensing agreements could open the door for biosimilar or generic suppliers. This development will broaden supply options and lower costs.

3. Supply Chain Digitization

Implementing blockchain, AI, and IoT solutions enhances transparency and traceability in the supply chain, reducing counterfeiting risks and improving compliance.

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Key Takeaways

• Primary Supplier: Merck KGaA remains the main patent holder and API producer for Tepotinib hydrochloride. Their integrated manufacturing network ensures consistent supply.

• CMO Collaboration: Several CMOs, including Fujifilm Diosynth and Boehringer Ingelheim, play vital roles in manufacturing and scale-up activities.

• Raw Material Sourcing: Specialty chemical suppliers in China and India provide intermediates used in tepotinib synthesis, emphasizing the importance of quality and compliance.

• Distribution Challenges: Ensuring global access involves overcoming logistical, regulatory, and capacity hurdles. Diversification and digital tools are essential.

• Market Outlook: Growing demand, potential patent cliff, and emergence of biosimilars will influence supplier landscape and supply chain strategies.

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FAQs

Q1: Who are the leading manufacturers of tepotinib hydrochloride?
A1: Merck KGaA is the primary manufacturer, supported by contract manufacturing organizations like Fujifilm Diosynth, Thermo Fisher Scientific, and Boehringer Ingelheim.

Q2: Are there generic suppliers for tepotinib hydrochloride?
A2: Currently, tepotinib remains under patent protection; however, patent expiry or licensing could lead to generic manufacturing by regional producers in the future.

Q3: What are the main raw material suppliers for tepotinib synthesis?
A3: Specialty chemical suppliers in China, India, and Europe, such as Shandong Xinhua Pharmaceutical and Sinochem, supply intermediates used in API production.

Q4: How does supply chain stability impact patient access?
A4: Disruptions can lead to shortages, delaying treatment. Manufacturers mitigate risks through diversification, strategic stockpiling, and supply chain digitization.

Q5: What are future trends affecting tepotinib supply?
A5: Expansion of regional manufacturing, development of biosimilars, and adoption of digital supply chain management are key trends shaping the future landscape.

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References:

1. [1] Merck KGaA official website. "Tepotinib (Tepmetko) for NSCLC." Accessed 2023.
2. [2] U.S. Food and Drug Administration (FDA). "Tepotinib Approval Summary." 2020.
3. [3] European Medicines Agency (EMA). "Regulatory Review of Tepotinib." 2021.
4. [4] Contract manufacturing capabilities in small-molecule drugs. PharmaTech Reports, 2022.
5. [5] Raw material supplier profiles. Chemical Industry Journal, 2023.