How India Exports Regorafenib to the World

In the United States, regorafenib is marketed under the brand name Stivarga. The FDA approved Stivarga for the treatment of metastatic colorectal cancer in September 2012, gastrointestinal stromal tumors in February 2013, and hepatocellular carcinoma in April 2017. The FDA's Orange Book lists several patents for Stivarga, including U.S. Patent Numbers 8,637,553 (expiring February 16, 2031), 8,680,124 (expiring June 2, 2030), 9,458,107 (expiring April 8, 2031), and 9,957,232 (expiring July 9, 2032). These patents have influenced the approval of generic versions. For instance, Actavis Laboratories FL, Inc. received FDA approval for its generic regorafenib tablets (40 mg) on December 10, 2020, under ANDA 209728. This approval reflects the FDA's commitment to increasing generic competition in the oncology sector.

The presence of 60 active Indian exporters indicates a robust supply chain catering to the U.S. market. However, exporters must navigate the FDA's stringent regulatory requirements, including compliance with Current Good Manufacturing Practices (cGMP) and potential import alerts. As of March 2026, there are no active FDA import alerts specifically targeting regorafenib from India, suggesting adherence to regulatory standards by Indian manufacturers.

In the European Union, the European Medicines Agency (EMA) granted marketing authorization for Stivarga (regorafenib) for metastatic colorectal cancer in August 2013, gastrointestinal stromal tumors in May 2014, and hepatocellular carcinoma in July 2017. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has aligned with EMA's decisions, ensuring continuity in the post-Brexit era. Compliance with EU Good Manufacturing Practice (GMP) guidelines is mandatory for manufacturers exporting to these markets. The significant export volume to France (73.8%) underscores the importance of adhering to these stringent standards.

As of the 24th edition of the WHO Model List of Essential Medicines, updated in September 2025, regorafenib is not included. This exclusion may influence procurement decisions in countries relying on the WHO list for essential medicines. Manufacturers must ensure compliance with international pharmacopoeia standards, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), to meet global quality expectations.

In India, regorafenib is classified under Schedule H of the Drugs and Cosmetics Rules, 1945, indicating it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for regorafenib as of March 2026, allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) for pharmaceutical products, ensuring compliance with export regulations.

Regorafenib's primary patents are held by Bayer HealthCare Pharmaceuticals, with expirations ranging from 2030 to 2032. The approval of generic versions, such as Actavis's in December 2020, indicates the onset of generic competition. However, ongoing patent protections may limit the full impact of generics in certain markets.

In April 2025, the EMA granted marketing authorization for Fruzaqla (fruquintinib), a new treatment for metastatic colorectal cancer, potentially impacting regorafenib's market share. In June 2025, the WHO updated its Model List of Essential Medicines, excluding regorafenib, which may influence its global procurement and utilization. In December 2025, the FDA approved a new generic version of regorafenib, increasing competition in the U.S. market. In February 2026, the NPPA announced a review of oncology drug prices, including regorafenib, which could affect pricing strategies in India. In March 2026, the DGFT streamlined the export NOC process for pharmaceuticals, potentially benefiting regorafenib exporters.

These developments underscore the dynamic nature of the pharmaceutical landscape for regorafenib, necessitating continuous monitoring and strategic adaptation by stakeholders.

India is a significant producer of Active Pharmaceutical Ingredients (APIs), including those for regorafenib. However, the production of these APIs often depends on Key Starting Materials (KSMs) sourced from China. According to the U.S. Pharmacopeia, 58% of KSMs used for U.S.-approved APIs are sole-sourced from a single country, with 41% from China and 16% from India. This heavy reliance on Chinese KSMs introduces vulnerabilities, as any disruption in China's supply chain can directly affect API production in India.

Recent geopolitical tensions have exacerbated these risks. In February 2026, the closure of the Strait of Hormuz disrupted the supply of petrochemical feedstocks essential for API synthesis. This disruption led to production cutbacks and force majeure declarations among Asian chemical manufacturers. Such events highlight the fragility of the supply chain for critical raw materials.

Our proprietary trade data indicates that the top five exporters of regorafenib from India account for 16.1% of total exports, with KARDI TRADING PRIVATE LIMITED leading at an 11.5% share. This relatively low concentration suggests a diversified supplier base, which can mitigate risks associated with supplier-specific disruptions.

The Indian government's Production Linked Incentive (PLI) scheme aims to bolster domestic API production and reduce dependency on imports. While this initiative is a positive step, its impact on reducing single-source risks for regorafenib's supply chain remains to be fully realized.

The closure of the Strait of Hormuz in February 2026 has had significant repercussions on global supply chains. Approximately 20% of the world's oil passes through this chokepoint, and its closure has led to increased transportation costs and delays. These disruptions have affected the pharmaceutical industry, leading to potential shortages and price increases for drugs, including those exported from India.

Additionally, tensions in the Red Sea and the Suez Canal have forced shipping companies to reroute vessels around the Cape of Good Hope, adding 10 to 14 days to transit times. Such delays can disrupt the timely delivery of pharmaceuticals, impacting patient care and inventory management.

• Diversify KSM Sources: Encourage API manufacturers to source KSMs from multiple countries to reduce dependency on any single nation.

• Enhance Domestic Production: Support initiatives like the PLI scheme to strengthen domestic API and KSM manufacturing capabilities.

• Develop Alternative Shipping Routes: Invest in infrastructure that allows for flexible shipping options to circumvent geopolitical hotspots.

• Strengthen Supplier Relationships: Foster strong partnerships with multiple suppliers to ensure a steady supply of regorafenib.

• Implement Robust Inventory Management: Maintain adequate buffer stocks to absorb short-term supply disruptions.

RISK_LEVEL: MEDIUM