How India Exports Canagliflozin to the World

In the United States, the FDA approved canagliflozin (Invokana) in March 2013 for the treatment of type 2 diabetes. Subsequently, in August 2014, the FDA approved Invokamet, a combination of canagliflozin and metformin hydrochloride, expanding treatment options for patients.

As of March 2026, the FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for generic versions of canagliflozin, indicating a competitive market landscape. The presence of 40 active Indian exporters supplying canagliflozin underscores India's significant role in the global supply chain.

Regarding safety communications, in May 2016, the FDA issued a Drug Safety Communication highlighting an increased risk of leg and foot amputations associated with canagliflozin use. Healthcare professionals were advised to monitor patients for signs of complications and consider discontinuing the drug if necessary.

The European Medicines Agency (EMA) granted marketing authorization for Invokana in November 2013, approving it for adults with type 2 diabetes to improve glycemic control. (ema.europa.eu) In July 2025, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended extending the indication to include children aged 10 years and older, reflecting an expansion in the drug's approved use. (ema.europa.eu)

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) issued safety communications in June 2016 and March 2017 regarding an increased risk of lower limb amputations, primarily affecting the toes, in patients treated with canagliflozin. Healthcare professionals were advised to monitor patients closely and consider discontinuing the drug if complications arose. (gov.uk)

Compliance with EU Good Manufacturing Practice (GMP) requirements is mandatory for manufacturers supplying canagliflozin to the European market, ensuring product quality and patient safety.

As of March 2026, canagliflozin is not listed on the World Health Organization's Model List of Essential Medicines. However, it is included in various pharmacopoeias, such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), establishing standardized quality benchmarks for the drug.

In India, canagliflozin is classified under Schedule H of the Drugs and Cosmetics Rules, 1945, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for canagliflozin as of March 2026, allowing market-driven pricing. For export purposes, manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with regulatory requirements.

The primary patent for canagliflozin expired in March 2024, opening the market to generic competition. This has led to increased participation from Indian exporters, with 40 active suppliers and a total export value of $0.9 million USD from 2022 to 2026.

In July 2025, the EMA's CHMP recommended extending the indication for Invokana to include pediatric patients aged 10 years and older, broadening the therapeutic scope of canagliflozin. (ema.europa.eu)

In March 2025, the NPPA conducted a review of anti-diabetic medications, including canagliflozin, to assess pricing and accessibility, though no immediate price controls were implemented.

In January 2025, the FDA approved a new generic version of canagliflozin, enhancing market competition and potentially reducing costs for patients.

In December 2024, the WHO updated its guidelines on the management of type 2 diabetes, acknowledging the role of SGLT2 inhibitors like canagliflozin in reducing cardiovascular risk.

In November 2024, the Indian Ministry of Health and Family Welfare issued a directive to monitor the safety profile of SGLT2 inhibitors, including canagliflozin, in response to global safety concerns.

These developments reflect the dynamic regulatory and market environment surrounding canagliflozin, emphasizing the importance of ongoing vigilance and compliance for stakeholders involved in its production and distribution.

Canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor used in the treatment of type 2 diabetes, is primarily manufactured in India. The production of its Active Pharmaceutical Ingredient (API) relies on Key Starting Materials (KSMs) and intermediates, a significant portion of which are sourced from China. According to the U.S. Pharmacopeia, 41% of KSMs used in U.S.-approved APIs are solely sourced from China, highlighting a substantial dependency on Chinese suppliers.

This reliance poses a risk to the supply chain, as any disruptions in China's production or export activities can directly impact the availability of Canagliflozin APIs. For instance, geopolitical tensions or regulatory changes in China could lead to supply shortages, affecting global pharmaceutical manufacturing.

Our proprietary trade data indicates that the top five Indian exporters of Canagliflozin account for 81.9% of the total export value, with LOTUS INTERNATIONAL leading at a 21.8% share. This high supplier concentration increases the risk of supply disruptions, as issues affecting these key exporters—such as operational challenges or regulatory non-compliance—could significantly impact global supply.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic API production and reduce dependency on imports. However, the effectiveness of this initiative in diversifying the supplier base for Canagliflozin remains to be fully realized.

Recent geopolitical events have further strained the pharmaceutical supply chain. On February 28, 2026, the United States and Israel initiated military strikes on Iran, leading to Iran's closure of the Strait of Hormuz—a critical maritime chokepoint through which approximately 20% of global oil passes. This action has caused significant disruptions in global shipping routes, leading to increased transit times and shipping costs.

Additionally, the Red Sea has experienced disruptions due to attacks on commercial vessels, further complicating shipping logistics. These geopolitical tensions have led to increased fuel prices and insurance premiums, impacting the cost and reliability of pharmaceutical shipments, including Canagliflozin exports from India.

• Diversify Supplier Base: Encourage the development of alternative suppliers for Canagliflozin APIs and KSMs to reduce dependency on a limited number of sources.

• Enhance Domestic Production: Support initiatives like the PLI scheme to strengthen domestic API manufacturing capabilities, thereby reducing reliance on imports.

• Develop Alternative Shipping Routes: Identify and establish alternative shipping routes to mitigate the impact of geopolitical disruptions on existing maritime channels.

• Increase Inventory Buffers: Maintain higher inventory levels of critical APIs and finished products to cushion against supply chain disruptions.

• Monitor Geopolitical Developments: Implement a robust monitoring system to stay informed about geopolitical events that could impact the supply chain, enabling proactive risk management.

RISK_LEVEL: HIGH