Bulk Pharmaceutical API Sources for TABRECTA

Bulk Pharmaceutical API Sources for TABRECTA

Vendor	Vendor Homepage	Vendor Sku	API Url
BioChemPartner		BCP9000785
Acesobio		cc-219
AK Scientific, Inc. (AKSCI)		Y0337
CEGChem		QC-7530
Wutech		RL00142
Angene Chemical		AGN-PC-04X71V
Aurum Pharmatech LLC		W-5775

Bulk Active Pharmaceutical Ingredient (API) Sources for TABRECTA (Selpercatinib)

Last updated: July 30, 2025

Introduction

Tabrecta (selpercatinib) is an orally administered kinase inhibitor used in the treatment of RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid carcinoma (MTC), and RET fusion-positive thyroid cancers. Since its FDA approval in 2020, securing a reliable supply of the active pharmaceutical ingredient (API) becomes essential for manufacturers, researchers, and supply chain stakeholders to meet global demand and ensure uninterrupted drug availability.

This article delves into the landscape of API sourcing for Tabrecta, highlighting the key suppliers, the criteria for selecting API vendors, regulatory considerations, and emerging trends shaping the supply chain.

Overview of API Manufacturing and Sourcing for Tabrecta

Selpercatinib, the API in Tabrecta, is a complex molecule with specific synthetic pathways. The manufacturing process involves multiple chemical synthesis steps, strict quality controls, and specialized facilities adhering to cGMP standards (current Good Manufacturing Practice).

Due to its targeted nature and high potency, sourcing high-quality, consistent API batches is imperative. Not only must suppliers meet regulatory compliance standards but also demonstrate robust supply security, competitive pricing, and advanced manufacturing capabilities.

Leading API Suppliers for Selpercatinib (Tabrecta)

1. Original Equipment Manufacturer (OEM) and Contract Manufacturing Organizations (CMOs)

Large pharmaceutical companies and specialized CMOs often serve as primary API sources for novel drugs like Tabrecta. As of recent data, the following entities are recognized for their roles in API supply:

• AbbVie Manufacturing Facilities: As the original developer of Tabrecta, AbbVie maintains in-house API manufacturing capabilities. Their multiple cGMP-compliant manufacturing plants across North America and Europe are capable of bulk API production, ensuring direct control over quality and supply.

• Fujifilm Toyama Chemical: A known supplier involved in high-potency API manufacturing, with experience in complex kinase inhibitors. Their facilities adhere to strict international quality standards.

• WuXi AppTec: A global contract development and manufacturing organization with proven expertise in small molecule APIs. WuXi’s facilities in China and the USA offer scalable manufacturing for complex compounds like selpercatinib.

• Boehringer Ingelheim: Known for high-containment manufacturing capabilities for targeted therapies, Boehringer Ingelheim supplies high-quality APIs for various oncology drugs, including those similar in complexity to selpercatinib.

2. Emerging and Specialized API Suppliers

Given the competitive landscape and the importance of supply chain resilience, newer suppliers have entered the fray:

• Suzhou Universal Biomedical Technology: Based in China, this firm has ramped up API production with established cGMP facilities for kinase inhibitors, including targeted oncology agents.

• Targeted Chemical Companies in India: Several Indian API manufacturers, such as Matrix Laboratories and Aurobindo Pharma, possess the capability to produce complex APIs and have begun manufacturing selpercatinib intermediates and APIs for export.

3. Raw Material and Intermediate Suppliers

Sourcing the intermediates and raw materials is equally essential. Companies like Jubilant Life Sciences and Sun Pharmaceutical Industries supply key chemical intermediates used in the synthesis of selpercatinib.

Criteria for Selecting API Suppliers for Tabrecta

Ensuring supply security and regulatory compliance requires meticulous selection based on:

• Regulatory Compliance: Suppliers must have current cGMP certifications from authorities such as the FDA, EMA, or PMDA.

• Manufacturing Capacity & Scalability: Ability to meet current demand and scale rapidly in response to market needs.

• Quality Assurance & Control: Rigorous testing for potency, purity, and stability; validated processes;

  and batch-to-batch consistency.

• Supply Chain Transparency: Proven track record of timely delivery, logistics support, and contingency planning.

• Intellectual Property & Confidentiality: Agreements that safeguard proprietary manufacturing processes and formulations.

Regulatory Considerations in API Sourcing

For API suppliers, compliance with regulatory standards is non-negotiable given Tabrecta’s therapeutic indications. Manufacturers must ensure:

• Maintaining cGMP Standards: Certification and routine audits to meet global standards.

• Documentation & Traceability: Complete batch records, stability data, and manufacturing process documentation.

• Regulatory Approvals: Suppliers with approved manufacturing facilities listed on drug master files (DMFs) submitted to authorities streamline approval processes.

Emerging Trends & Challenges in API Supply for Targeted Oncology Drugs

1. Supply Chain Diversification

Global disruptions, such as the COVID-19 pandemic, underscore the importance of diversified API sourcing. Many pharma companies are enhancing their vendor networks across different regions to mitigate risks associated with political, logistical, or quality issues.

2. Advanced Manufacturing Technologies

Adoption of continuous flow synthesis, high-containment manufacturing, and process automation helps streamline production, improve yields, and reduce costs.

3. Regulatory Harmonization

Increasing alignment of regulatory standards across regions facilitates faster approvals and smoother cross-border API shipments.

4. Intellectual Property & Exclusivity

As the patent for Tabrecta nears expiry, generic manufacturers may enter the market, further expanding API sources and impacting pricing and supply dynamics.

Conclusion

The supply landscape for the API of Tabrecta reveals a mix of original equipment manufacturers, specialized CMOs, and emerging regional suppliers. Ensuring a reliable, high-quality API supply chain involves careful selection based on regulatory credentials, manufacturing capacity, and global logistics capabilities.

As targeted therapies like selpercatinib continue to grow in prominence, securing diversified, compliant, and scalable API sources remains a strategic priority for pharmaceutical companies and supply chain stakeholders.

Key Takeaways

• Leading API sources for Tabrecta include AbbVie’s internal manufacturing facilities, WuXi AppTec, and Boehringer Ingelheim, among others.

• Supplier qualification hinges on regulatory compliance, manufacturing capacity, quality assurance, and supply chain robustness.

• Regional diversification and advanced manufacturing technologies are critical trends bolstering supply security.

• Regulatory compliance and documentation streamline approval processes and ensure product integrity.

• The approaching patent expiry of Tabrecta presents opportunities for new entrants, potentially increasing API supply options and impacting market dynamics.

FAQs

1. How does the complexity of selpercatinib’s synthesis affect API sourcing?
Selpercatinib’s synthesis involves multiple stereoselective steps and sensitive intermediates, necessitating suppliers with advanced synthesis capabilities and stringent quality controls. The complexity restricts rapid scale-up, making supplier expertise crucial.

2. What are the primary regulatory hurdles for API suppliers of targeted oncology agents?
Suppliers must demonstrate compliance with cGMP standards, provide comprehensive documentation, and obtain certifications from authorities like the FDA and EMA. Additionally, they need to maintain rigorous quality testing and traceability.

3. How does supply chain diversification benefit pharma companies producing Tabrecta?
Diversification reduces dependency on a single supplier or region, mitigating risks from geopolitical issues, pandemics, or regulatory delays, thus ensuring continuous drug supply.

4. Are there sustainable or environmentally friendly manufacturing practices among API suppliers?
Increasingly, API manufacturers adopt green chemistry principles, minimize waste, and utilize renewable energy sources. Suppliers demonstrating sustainability credentials may have a competitive edge.

5. How might patent expiration influence the API sourcing landscape for selpercatinib?
Patent expiry typically invites generic manufacturers, broadening API sources and potentially reducing costs. This can improve supply resilience but may also lead to increased market competition.

---

Sources:

[1] FDA Drug Approvals and Regulatory filings.
[2] AbbVie Official Reports.
[3] Contract Manufacturing Organization (CMO) disclosures.
[4] Industry reports on API manufacturing trends.
[5] Regulatory guidelines from EMA and ICH.