How India Exports Apixaban to the World

As of March 2026, the FDA Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for Apixaban, indicating a competitive generic market in the United States. Recent approvals include those granted in January 2026, reflecting ongoing interest in Apixaban's therapeutic applications. The regulatory pathway for Apixaban involves demonstrating bioequivalence to the reference listed drug, Eliquis, and compliance with Current Good Manufacturing Practices (cGMP). Given the presence of 171 active Indian exporters, it is imperative for manufacturers to ensure adherence to FDA regulations to maintain market access and avoid potential import alerts.

In the European Union, Apixaban is marketed under the brand name Eliquis, with marketing authorization granted by the European Medicines Agency (EMA) in May 2011. Generic versions, such as Apixaban Accord, received EMA approval in July 2020. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) continues to recognize these authorizations post-Brexit. Manufacturers exporting to the EU and UK must comply with EU Good Manufacturing Practice (GMP) guidelines, which encompass stringent quality control measures and regular inspections to ensure product safety and efficacy.

Apixaban is included in the 22nd edition of the WHO Model List of Essential Medicines, underscoring its importance in global health. While specific WHO Prequalification for Apixaban is not documented, adherence to international pharmacopoeia standards—such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP)—is crucial for manufacturers to ensure global acceptance and compliance with quality standards.

In India, Apixaban is classified under Schedule H of the Drugs and Cosmetics Act, requiring a prescription for dispensation. The National Pharmaceutical Pricing Authority (NPPA) has not imposed a ceiling price on Apixaban as of March 2026, allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with national regulations and to monitor the quality of pharmaceutical exports.

The primary patent for Apixaban expired in December 2019, leading to increased generic competition globally. This has facilitated the entry of multiple manufacturers into the market, contributing to the substantial export figures from India.

In May 2024, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an extension of the marketing authorization for Eliquis to include pediatric indications, specifically for the treatment and prevention of venous thromboembolism (VTE) in children aged 28 days to less than 18 years. (ema.europa.eu)

In November 2023, the CHMP recommended the removal of a pharmaceutical form (powder and solvent for oral solution) and a change to an existing indication for the use of Pradaxa in children under 18 years of age. (ema.europa.eu)

These developments reflect the dynamic regulatory landscape for anticoagulants like Apixaban, emphasizing the need for manufacturers to stay informed and compliant with evolving international standards and approvals.

Apixaban, a widely used anticoagulant, is primarily manufactured in India. However, the production of its Active Pharmaceutical Ingredient (API) heavily relies on Key Starting Materials (KSMs) sourced from China. China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a dominant player in this sector. This dependency poses a significant risk, as any disruption in the supply chain from China can directly impact the availability of Apixaban APIs in India.

Recent geopolitical tensions have exacerbated these risks. For instance, the closure of the Strait of Hormuz in March 2026 disrupted the supply of raw materials to Asia's petrochemical industry, leading to production cutbacks and force majeure declarations. Such events highlight the vulnerability of the pharmaceutical supply chain to geopolitical disruptions, emphasizing the need for diversification and resilience in sourcing strategies.

The export market for Apixaban from India is highly concentrated, with the top five exporters accounting for 83.6% of the total export value. MACLEODS PHARMACEUTICALS LTD alone holds a 48.6% share, amounting to $87.5 million USD. This high level of supplier concentration increases the risk of supply chain disruptions, as any operational issues within these key companies can significantly impact global Apixaban availability.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at reducing import dependence on critical pharmaceutical ingredients. In November 2024, two greenfield plants were inaugurated under this scheme to manufacture essential molecules used in common antibiotics, marking a significant step towards self-reliance in API production. While this initiative primarily targets antibiotics, it sets a precedent for similar efforts in other pharmaceutical sectors, including anticoagulants like Apixaban.

The closure of the Strait of Hormuz in March 2026 had a profound impact on global supply chains, particularly affecting the pharmaceutical industry. The strait is a critical chokepoint through which approximately 20% of the world's oil supply passes. Its closure led to a sharp decline in maritime transit, with tanker traffic dropping by about 70% and over 150 ships anchoring outside the strait to avoid risks. This disruption not only affected energy supplies but also had cascading effects on the transportation of pharmaceutical raw materials and finished products.

Additionally, tensions in the Red Sea and the Strait of Hormuz have further strained global shipping routes. The Red Sea, a vital corridor for maritime trade, has experienced disruptions due to geopolitical conflicts, leading to increased shipping costs and delays. These factors collectively contribute to the volatility of the pharmaceutical supply chain, underscoring the need for strategic planning and risk mitigation measures.

• Diversify Sourcing of KSMs and APIs: Reduce dependency on a single country by establishing alternative sources for Key Starting Materials and Active Pharmaceutical Ingredients.

• Enhance Domestic Production Capabilities: Invest in local manufacturing facilities to produce critical pharmaceutical ingredients, thereby reducing reliance on imports.

• Strengthen Supplier Relationships: Develop robust partnerships with multiple suppliers to ensure a steady supply chain and mitigate risks associated with supplier concentration.

• Implement Advanced Supply Chain Monitoring: Utilize real-time tracking and analytics to identify potential disruptions early and respond proactively.

• Develop Contingency Plans: Establish comprehensive risk management strategies, including alternative shipping routes and inventory buffers, to address potential geopolitical and logistical disruptions.

RISK_LEVEL: HIGH