Bulk Pharmaceutical API Sources for TERIFLUNOMIDE

Bulk Pharmaceutical API Sources for TERIFLUNOMIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-005-943-824
AKos Consulting & Solutions		AKOS015994773
Key Organics/BIONET		LE-0275
Molport		MolPort-035-386-190
AvaChem Scientific		163451-81-8

Bulk Active Pharmaceutical Ingredient (API) Sources for: TERIFLUNOMIDE

Last updated: July 29, 2025

Introduction

Teriflunomide, marketed as Aubagio by Sanofi, is an oral immunomodulatory agent approved for the treatment of relapsing forms of multiple sclerosis (MS). As a disease-modifying therapy, its manufacturing relies heavily on the procurement of high-quality active pharmaceutical ingredients (APIs). The sourcing of teriflunomide API is strategic, involving multiple global suppliers that meet stringent quality standards to ensure safety, efficacy, and regulatory compliance. This report provides an in-depth analysis of key bulk API sources for teriflunomide, highlighting industry players, geographic considerations, and supply chain dynamics.

---

Overview of API Manufacturing for Teriflunomide

Teriflunomide is a synthetic, small-molecule compound derived through complex chemical synthesis. Its synthesis involves key intermediates obtained via multistep chemical reactions, requiring advanced manufacturing capabilities. The API must conform to Good Manufacturing Practices (GMP), with certifications from regulatory authorities such as the FDA, EMA, or local agencies.

Suppliers of teriflunomide API predominantly operate across Europe, China, and India—areas with established pharmaceutical manufacturing expertise. The selection of a supplier is influenced by factors including manufacturing capacity, regulatory track record, cost, and quality assurance.

---

Major API Suppliers for Teriflunomide

1. Sanofi (Internal API Production & Contract Manufacturers)

Sanofi has historically retained control over some API manufacturing for critical products like teriflunomide. The company operates its own production facilities in Europe and collaborates with approved third-party manufacturers to ensure supply security. While specific API manufacturing sites are not publicly disclosed due to confidentiality, Sanofi's rigorous quality standards extend across its supply chain, including partnerships with GMP-certified facilities.

2. Chinese API Manufacturers

China remains a pivotal hub for bulk API production due to its robust chemical synthesis industry and cost advantages. Several Chinese API manufacturers produce teriflunomide API under strict GMP conditions.

• Hunan Er-Kang Pharmaceutical Co., Ltd.: Known for producing various small-molecule APIs, including immunomodulators. The company’s GMP-certified facilities and compliance with international standards make it a notable source.

• Zhejiang Hisun Pharmaceuticals: A leading manufacturer with advanced chemical synthesis capabilities, capable of scaling large batches of APIs including teriflunomide.

• Jiangsu Hengrui Medicine Co., Ltd.: A globally recognized pharmaceutical firm with extensive API manufacturing capacity, Hengrui supplies APIs to various generic manufacturers.

3. Indian API Manufacturers

India’s pharmaceutical industry boasts a vast network of API producers capable of supplying high-quality APIs for export markets and domestic use.

• Laurus Labs: An established player in small-molecule APIs, including immunology drugs; known for stringent quality protocols aligned with international standards.

• Sun Pharmaceutical Industries Ltd.: One of India’s largest pharma companies, with a dedicated API wing capable of manufacturing teriflunomide with compliance to GMP.

• AstraZeneca’s Contract Manufacturing Partners in India: Some APIs are sourced through strategic outsourcing arrangements to Indian manufacturers with proven GMP compliance.

4. European API Manufacturers

While European manufacturers tend to supply for high-end segments due to regulatory differences and quality controls, they are crucial in supply chains requiring compliance with stringent European standards.

• Recipharm (Sweden): Offers API development and manufacturing services with GMP certification, catering to European and global markets.

• Evonik Industries (Germany): Known for fine chemical synthesis and complex APIs, capable of providing high-purity teriflunomide APIs.

---

Quality and Regulatory Considerations

API suppliers for teriflunomide must demonstrate adherence to international standards including EPA, USP, Ph. Eur., and ICH guidelines. Suppliers should possess comprehensive documentation, stability data, and audit histories. Regulatory agencies like the FDA or EMA scrutinize API manufacturing sites to prevent supply chain disruptions and ensure product integrity.

Many manufacturers undergo rigorous inspection cycles, with some obtaining bilateral agreements or import tolerances. Additionally, suppliers with WHO-GMP or equivalent certification are preferred for markets with strict regulatory landscapes.

---

Supply Chain Dynamics and Market Trends

The global supply chain for APIs faces challenges such as geopolitical tensions, regulatory harmonization, and pandemic-related disruptions. Suppliers diversify by establishing multiple production sites to mitigate risks.

Emerging trends include:

• Shift toward integrated manufacturing with vertical supply chains to enhance quality control.
• Increasing procurement from Indian and Chinese suppliers due to cost efficiencies.
• Elevating industry standards for quality assurance and transparency.

---

Emerging API Production Technologies

Innovations in API synthesis, including flow chemistry and biocatalysis, are influencing the production of complex molecules like teriflunomide. These technologies enable higher yields, fewer impurities, and environmental sustainability, attracting newer suppliers into the market.

---

Challenges in API Sourcing for Teriflunomide

Key challenges include:

• Ensuring supplier compliance across diverse regulatory landscapes.
• Managing geopolitical risks, especially related to Chinese and Indian API manufacturers.
• Maintaining high standards amid cost pressures.
• Navigating patent protections and licensing agreements.

---

Conclusion

The procurement landscape for teriflunomide API is characterized by a diversified network of global suppliers, primarily located in China, India, and Europe. Manufacturers with proven GMP compliance, robust quality systems, and flexible scaling capabilities dominate this sector. Strategic supplier selection considers not only price but also regulatory adherence and supply chain resilience.

---

Key Takeaways

• Diversify suppliers across regions to mitigate geopolitical and logistical risks.
• Prioritize GMP-certified manufacturers with proven compliance to ensure product quality.
• Leverage technological advancements in synthesis methods to improve API yield and purity.
• Monitor regulatory developments in major sourcing countries to anticipate compliance requirements.
• Establish strategic partnerships with reliable API suppliers to secure long-term supply stability.

---

FAQs

1. Are Chinese API manufacturers a reliable source of teriflunomide?
Yes. Several Chinese manufacturers comply with GMP standards and have international certifications, making them reliable suppliers for teriflunomide APIs, especially when assessed through audits and documentation reviews.

2. How does regulatory compliance impact API sourcing for teriflunomide?
Regulatory compliance ensures API safety, quality, and consistency. Suppliers with recognized certifications (e.g., GMP, ISO) streamline approval processes and reduce risk of supply disruptions.

3. What are the key factors influencing API price negotiations?
Price is influenced by manufacturing scale, regulatory compliance, quality assurance practices, geopolitical stability, and logistical considerations.

4. Is there a trend towards sourcing APIs from emerging markets?
Yes. India and China dominate API manufacturing due to cost efficiencies and expanding production capacity, though European suppliers are favored for high-end, regulatory-sensitive products.

5. What role do contract manufacturing organizations (CMOs) play in API supply for teriflunomide?
CMOs enable pharmaceutical companies to outsource API production, offering flexibility, cost advantages, and access to specialized manufacturing capabilities, often serving as critical links in supply chain diversification.

---

References

1. Sanofi. (2022). Aubagio (Teriflunomide): Prescribing Information.
2. UMC (Union Medisteel Corporation). API Manufacturing in China, 2023.
3. Pharma IQ. API Market Overview: Strategies and Challenges, 2022.
4. WHO. Good Manufacturing Practices for Active Pharmaceutical Ingredients, 2019.
5. ICCR (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). Guidelines on API Quality, 2021.