How India Exports Liraglutide to the World

As of March 2026, the FDA's Orange Book lists no approved Abbreviated New Drug Applications (ANDAs) for liraglutide, indicating the absence of generic versions in the U.S. market. The original New Drug Application (NDA) for liraglutide, marketed as Victoza, was approved on June 30, 2009. Given the limited export volume to the U.S. (0.7% of total exports), Indian manufacturers aiming to penetrate this market must navigate the FDA's stringent regulatory pathways, including the submission of an NDA or ANDA, adherence to Good Manufacturing Practices (GMP), and potential pre-approval inspections.

The European Medicines Agency (EMA) granted marketing authorization for Victoza (liraglutide) on June 30, 2009, for the treatment of type 2 diabetes mellitus in adults, adolescents, and children aged 10 years and above. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) continues to recognize this authorization post-Brexit. Manufacturers exporting to these regions must comply with the EU's GMP standards, which encompass quality management, personnel qualifications, and facility requirements. Regular inspections ensure compliance, and any deviations can result in corrective actions or suspension of manufacturing licenses.

In September 2025, the World Health Organization (WHO) included GLP-1 therapies, such as liraglutide, in its 24th Model List of Essential Medicines for managing type 2 diabetes in high-risk groups. This inclusion underscores liraglutide's significance in global health. Manufacturers should ensure that their products meet the standards set forth in recognized pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), to facilitate international acceptance and compliance.

In India, liraglutide is classified under Schedule H of the Drugs and Cosmetics Act, necessitating a prescription for its dispensation. The National Pharmaceutical Pricing Authority (NPPA) has not imposed a ceiling price on liraglutide as of March 2026, allowing market-driven pricing. For exports, manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations and facilitating smooth international trade.

The primary patent for liraglutide, held by Novo Nordisk, expired in 2022, opening the market to generic competition. However, the absence of approved ANDAs in the U.S. suggests that generic manufacturers are still in the process of navigating regulatory approvals. This presents an opportunity for Indian pharmaceutical companies to enter the market, provided they meet the requisite regulatory standards.

In December 2025, the WHO issued its first guideline on the use of GLP-1 therapies, including liraglutide, for treating obesity as a chronic disease. This development is expected to increase global demand for liraglutide. Additionally, in April 2025, the WHO unveiled a global repository for National Essential Medicines Lists (nEMLs), providing a centralized platform that includes liraglutide, thereby facilitating its adoption in national healthcare systems. These developments highlight the growing recognition of liraglutide's therapeutic value and may influence regulatory policies and market dynamics globally.

Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is primarily manufactured in India for export. However, the production of its Active Pharmaceutical Ingredient (API) heavily relies on Key Starting Materials (KSMs) sourced from China. This dependency is significant, as China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a dominant player in the pharmaceutical raw material market.

Recent disruptions have highlighted the vulnerabilities associated with this reliance. In early 2025, the FDA declared the shortage of semaglutide injection products resolved as of February 21, 2025, after a period of increased demand and supply constraints. Similarly, in 2023 and 2024, shortages of Victoza (liraglutide) occurred in some countries due to a temporary supply reduction and increased demand. (ema.europa.eu) These events underscore the risks associated with concentrated sourcing of critical raw materials.

Our proprietary trade data indicates a high supplier concentration in the export of liraglutide from India. The top five exporters account for 98.1% of the total export value, with SUN PHARMACEUTICAL INDUSTRIES LIMITED alone contributing 52.6%. This concentration poses a significant single-source risk, as any disruption affecting these key suppliers could severely impact the global supply chain.

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 October 2024, two greenfield plants were inaugurated under this scheme to manufacture essential molecules like Penicillin G and Clavulanic Acid, marking a strategic move towards self-reliance in API production.

The global pharmaceutical supply chain is susceptible to geopolitical tensions and shipping disruptions. Key maritime routes such as the Red Sea and the Strait of Hormuz are critical for the transportation of pharmaceutical products. Any instability in these regions can lead to delays and increased costs. Additionally, ongoing U.S.-China trade tensions have the potential to disrupt the supply of KSMs and APIs, further exacerbating supply chain vulnerabilities.

Regulatory agencies have responded to these challenges. For instance, the FDA has been actively monitoring drug availability and working to determine whether the demand or projected demand for each drug in shortage exceeds the available supply. Such measures aim to ensure continued patient access to essential medications despite supply chain disruptions.

• Diversify Supplier Base: Encourage the development of alternative suppliers for both APIs and KSMs to reduce dependency on a single source or region.

• Enhance Domestic Production: Invest in domestic manufacturing capabilities for critical raw materials and APIs to bolster self-reliance and reduce import dependence.

• Strengthen Supply Chain Monitoring: Implement robust monitoring systems to detect early signs of supply disruptions and enable proactive responses.

• Develop Strategic Reserves: Establish reserves of essential APIs and KSMs to buffer against short-term supply interruptions.

• Foster International Collaboration: Engage in international partnerships to share best practices, resources, and information to collectively address supply chain challenges.

RISK_LEVEL: HIGH