How India Exports Dapagliflozin to the World

Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, is approved in the United States for the treatment of type 2 diabetes mellitus, heart failure, and chronic kidney disease. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for dapagliflozin, indicating the presence of generic versions in the market. The most recent approval was granted in March 2023. As of March 2026, there are no active FDA import alerts specifically targeting dapagliflozin, suggesting compliance with regulatory standards.

India's significant role in the pharmaceutical supply chain is evident, with 254 active exporters contributing to a total export value of $49.5 million USD for dapagliflozin between 2022 and 2026. This robust exporter base underscores India's capacity to meet the demand for dapagliflozin in the U.S. market.

In the European Union, dapagliflozin is marketed under the brand name Forxiga and has been authorized since November 2012. The European Medicines Agency (EMA) approved a generic version, Dapagliflozin Viatris, on 24 March 2023. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the authorization of dapagliflozin-containing products. Notably, in December 2021, the MHRA announced the withdrawal of dapagliflozin's indication for type 1 diabetes mellitus, a decision based on commercial considerations rather than new safety concerns. (gov.uk)

Compliance with EU Good Manufacturing Practice (GMP) requirements is mandatory for manufacturers exporting to the EU and UK. This includes adherence to stringent quality standards and regular inspections to ensure product safety and efficacy.

Dapagliflozin is included in the World Health Organization's Model List of Essential Medicines, reflecting its importance in managing type 2 diabetes mellitus. The drug is subject to international pharmacopoeia standards, including those of the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring consistent quality across different markets.

In India, dapagliflozin is classified under Schedule H, indicating that it is a prescription-only medication. The Drug Price Control Order (DPCO), enforced by the National Pharmaceutical Pricing Authority (NPPA), regulates the pricing of essential medicines, including dapagliflozin. As of March 2026, the ceiling price for dapagliflozin has been set to ensure affordability. Exporters are required to obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for the export of pharmaceutical products, ensuring compliance with national regulations.

The primary patent for dapagliflozin has expired, allowing for the introduction of generic versions into the market. This has led to increased competition among manufacturers, contributing to the availability of more affordable treatment options for patients.

In July 2025, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the extension of the indication for Invokana (canagliflozin) to include treatment of children from 10 years of age with type 2 diabetes mellitus. (ema.europa.eu)

In November 2023, the CHMP adopted a positive opinion recommending the extension of the indication for Jardiance (empagliflozin) to include the treatment of chronic kidney disease in adults. (ema.europa.eu)

These developments reflect the evolving regulatory landscape and the expanding therapeutic applications of SGLT2 inhibitors, including dapagliflozin, in managing various health conditions.

India's pharmaceutical industry, while a major producer of Active Pharmaceutical Ingredients (APIs), remains significantly dependent on China for Key Starting Materials (KSMs). As of 2024, approximately 35% of India's API requirements were met through imports, with a substantial portion sourced from China. This reliance exposes the supply chain to vulnerabilities, particularly when geopolitical tensions or trade disruptions arise.

The closure of the Strait of Hormuz in March 2026, a critical chokepoint for global oil and gas shipments, has further exacerbated supply chain challenges. The blockade has led to surging energy costs and logistical disruptions, impacting the availability and pricing of essential raw materials for pharmaceutical manufacturing. These developments underscore the pressing need for India to bolster its domestic production capabilities for KSMs and APIs to mitigate external dependencies.

Our proprietary trade data indicates that the top five exporters of Dapagliflozin from India account for 60.7% of the total export value, with AJANTA PHARMA LIMITED leading at a 17.1% share. This high supplier concentration poses a significant risk, as disruptions affecting any of these key players could severely impact the global supply of Dapagliflozin.

To address such vulnerabilities, the Indian government has implemented the Production Linked Incentive (PLI) Scheme, aiming to enhance domestic manufacturing of APIs and reduce reliance on imports. The PLI scheme incentivizes local production of 41 identified APIs, including those critical for various therapeutic categories. (pharmanow.live) While this initiative is a step toward supply chain resilience, its effectiveness in diversifying the supplier base for Dapagliflozin remains to be fully realized.

The recent blockade of the Strait of Hormuz in March 2026 has had profound implications for global supply chains. As a vital passage for approximately 20% of the world's oil and gas shipments, its closure has led to increased energy costs and logistical challenges. These disruptions have particularly affected the pharmaceutical sector, leading to delays and increased costs in the transportation of APIs and finished products.

Additionally, escalating tensions in the Red Sea and the Strait of Hormuz have further complicated shipping routes, causing major shipping companies to reroute vessels and suspend operations in affected areas. (lemonde.fr) These geopolitical developments have introduced significant uncertainties into the pharmaceutical supply chain, emphasizing the need for robust risk mitigation strategies.

• Diversify Supplier Base: Encourage the development of alternative suppliers for Dapagliflozin and its raw materials to reduce dependency on a limited number of exporters.

• Enhance Domestic Production: Accelerate the implementation and expansion of the PLI scheme to strengthen domestic manufacturing capabilities for APIs and KSMs.

• Develop Alternative Shipping Routes: Invest in infrastructure and logistics to establish alternative shipping routes that bypass geopolitical hotspots, ensuring uninterrupted supply chains.

• Strengthen Inventory Management: Implement strategic stockpiling of critical APIs and raw materials to buffer against supply chain disruptions.

• Monitor Geopolitical Developments: Establish a dedicated task force to continuously monitor geopolitical events and assess their potential impact on the pharmaceutical supply chain.

RISK_LEVEL: HIGH