How India Exports Vildagliptin to the World

As of March 2026, vildagliptin has not received approval from the U.S. Food and Drug Administration (FDA) for marketing in the United States. Consequently, there are no approved Abbreviated New Drug Applications (ANDAs) for vildagliptin listed in the FDA's Orange Book. This absence of approval indicates that vildagliptin cannot be legally marketed or imported into the U.S. Given that 178 Indian exporters are active in the vildagliptin market, the lack of FDA approval presents a significant barrier to accessing the U.S. pharmaceutical market.

In the European Union, vildagliptin has been authorized for use in the treatment of type 2 diabetes mellitus. The European Medicines Agency (EMA) granted marketing authorization for Galvus (vildagliptin) on 26 September 2007. Additionally, combination products such as Eucreas (vildagliptin/metformin) received authorization on 14 November 2007. These approvals necessitate compliance with EU Good Manufacturing Practice (GMP) standards, ensuring that manufacturing processes meet stringent quality requirements. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) continues to recognize these authorizations post-Brexit, maintaining alignment with EMA's regulatory decisions.

As of March 2026, vildagliptin is not listed on the World Health Organization's (WHO) Model List of Essential Medicines. Consequently, it has not undergone the WHO Prequalification Programme, which assesses the quality, safety, and efficacy of medicinal products. Regarding pharmacopoeial standards, vildagliptin is included in the European Pharmacopoeia (EP), British Pharmacopoeia (BP), and Indian Pharmacopoeia (IP), providing standardized quality benchmarks for its production and quality control.

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

The primary patent for vildagliptin, held by Novartis, expired in 2019, opening the market to generic competition. This expiration has led to increased production and export activities by Indian pharmaceutical companies, contributing to the $10.2 million USD export value recorded between 2022 and 2026.

In September 2025, the FDA established a "green list" import alert to prevent potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients from unverified foreign sources from entering the U.S. market. This measure aims to safeguard consumers from illegal GLP-1 active ingredients imported from overseas.

In January 2026, the FDA requested the removal of suicidal behavior and ideation warnings from GLP-1 receptor agonist medications, including Saxenda (liraglutide), Wegovy (semaglutide), and Zepbound (tirzepatide). This decision followed a comprehensive review that found no increased risk of suicidal ideation or behavior associated with these medications.

These developments reflect the dynamic nature of the pharmaceutical regulatory landscape, emphasizing the importance of continuous monitoring and compliance with evolving standards.

Vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor used in the management of type 2 diabetes, is primarily manufactured in India. However, the production of its Active Pharmaceutical Ingredient (API) is heavily reliant on Key Starting Materials (KSMs) sourced from China. This dependency is part of a broader trend where approximately 60–70% of KSMs and intermediates used in Indian pharmaceutical manufacturing are imported from China.

Recent disruptions have highlighted the vulnerabilities associated with this reliance. In September 2025, Chinese manufacturers significantly reduced the prices of 41 specific APIs and KSMs by 40% to 50%, a move perceived as an attempt to undermine India's efforts toward self-sufficiency in API production. Such pricing strategies can destabilize the Indian pharmaceutical market, making it challenging for local manufacturers to compete and sustain operations.

Our proprietary trade data indicates that the top five Indian exporters of Vildagliptin account for 54.7% of the total export value, with AJANTA PHARMA LIMITED leading at 18.0%. This concentration suggests a moderate risk, as disruptions affecting these key suppliers could significantly impact global supply chains.

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 like Penicillin G and 6-Aminopenicillanic acid (6-APA), marking a significant step toward enhancing domestic production capabilities.

Geopolitical tensions and shipping disruptions pose additional risks to the Vildagliptin supply chain. The Red Sea and the Strait of Hormuz are critical maritime routes for pharmaceutical exports; any instability in these regions can lead to delays and increased shipping costs. Furthermore, escalating U.S.-China tensions have raised concerns about the stability of supply chains, particularly for APIs and KSMs sourced from China.

Regulatory agencies have also reported shortages related to similar pharmaceutical products. For instance, in February 2025, the FDA announced the resolution of a semaglutide injection shortage, a GLP-1 medication, which had been in shortage since 2022 due to increased demand. While not directly related to Vildagliptin, such instances underscore the potential for supply chain vulnerabilities affecting diabetes medications.

• Diversify KSM Sourcing: Identify and develop alternative suppliers for KSMs beyond China to reduce dependency and enhance supply chain resilience.

• Strengthen Domestic Production: Leverage government initiatives like the PLI scheme to bolster domestic manufacturing of APIs and KSMs, thereby decreasing reliance on imports.

• Enhance Supplier Audits: Implement rigorous quality control and compliance audits for existing suppliers to ensure adherence to Good Manufacturing Practices (GMP) and mitigate risks associated with substandard products.

• Monitor Geopolitical Developments: Establish a dedicated team to track geopolitical events and assess their potential impact on supply chains, enabling proactive risk management.

• Develop Contingency Plans: Create comprehensive contingency strategies, including alternative shipping routes and emergency stockpiles, to address potential disruptions in the supply chain.

RISK_LEVEL: MEDIUM