How India Exports Montelukast to the World

In the United States, Montelukast is approved under the brand name Singulair, with numerous generic versions available. The FDA's Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for Montelukast Sodium Tablets, 10 mg. For instance, Sandoz Inc. received approval for its generic version on July 11, 2012. The regulatory pathway for Montelukast involves demonstrating bioequivalence to the reference listed drug, Singulair. Given the substantial number of active Indian exporters (510) supplying Montelukast to the U.S., it is imperative for these entities to adhere strictly to FDA regulations to maintain market access.

In the European Union, Montelukast has been subject to regulatory scrutiny to ensure harmonized safety and efficacy standards. The European Medicines Agency (EMA) conducted a Periodic Safety Update Report Single Assessment (PSUSA) for Montelukast, resulting in a variation to its marketing authorization in May 2019. (ema.europa.eu) Additionally, in April 2008, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended harmonizing the Summary of Product Characteristics (SPC), labeling, and package leaflet for Singulair and associated names. (ema.europa.eu) Compliance with EU Good Manufacturing Practice (GMP) requirements is mandatory for Indian exporters targeting the EU and UK markets.

Montelukast is included in the World Health Organization's Model List of Essential Medicines, underscoring its importance in global health. The drug is also subject to international pharmacopoeia standards, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). Adherence to these standards is crucial for ensuring the quality and efficacy of Montelukast in international markets.

In India, Montelukast 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 Montelukast, allowing market-driven pricing. For export purposes, Indian manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with national regulations.

The primary patents for Montelukast have expired, leading to a competitive generic market. This has facilitated the entry of multiple generic manufacturers, including those from India, into global markets. The absence of patent restrictions has contributed to the significant export volume of Montelukast from India.

In March 2025, the EMA published a list of nationally authorized medicinal products containing Montelukast, reflecting ongoing regulatory oversight. (ema.europa.eu) Additionally, in December 2025, the EMA's CHMP adopted a positive opinion recommending a new indication for Nucala (mepolizumab) in the treatment of chronic obstructive pulmonary disease (COPD), indicating evolving treatment landscapes in respiratory conditions. (ema.europa.eu) These developments highlight the dynamic nature of the pharmaceutical industry and the importance of staying abreast of regulatory changes.

In conclusion, the regulatory landscape for Montelukast is multifaceted, encompassing stringent requirements across major markets. Indian exporters must navigate these regulations diligently to maintain and expand their global market presence.

Montelukast, a widely used leukotriene receptor antagonist, 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 exposes the Montelukast supply chain to potential disruptions stemming from geopolitical tensions, trade policies, and environmental regulations in China.

Recent disruptions have underscored these vulnerabilities. Between 2022 and 2024, several major Montelukast API suppliers received FDA warning letters due to deficiencies in data integrity, contamination control, and batch release procedures. These regulatory actions temporarily constrained market supply and elevated compliance costs across the industry. Such incidents highlight the critical importance of maintaining robust quality management systems and the risks associated with over-reliance on a single source for raw materials.

The export data from TransData Nexus indicates a significant concentration among Indian exporters of Montelukast. The top five exporters account for 64.8% of the total export value, with MACLEODS PHARMACEUTICALS LTD alone contributing 38.2%. This high supplier concentration poses a single-source risk, where disruptions affecting a major exporter can have cascading effects on the global supply chain.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic manufacturing of APIs and reduce dependency on imports. While this initiative is a step towards diversifying the supplier base, its effectiveness in the Montelukast supply chain remains to be fully realized.

The Montelukast supply chain is susceptible to geopolitical and shipping disruptions. Tensions in critical maritime routes such as the Red Sea and the Strait of Hormuz can lead to delays and increased shipping costs. Additionally, ongoing US-China trade tensions have the potential to impact the availability and pricing of KSMs sourced from China.

Regulatory actions have also contributed to supply chain challenges. Between 2022 and 2024, several major Montelukast API suppliers received FDA warning letters due to deficiencies in data integrity, contamination control, and batch release procedures. These regulatory actions temporarily constrained market supply and elevated compliance costs across the industry. Such incidents underscore the importance of maintaining robust quality management systems and the risks associated with over-reliance on a single source for raw materials.

• Diversify Supplier Base: Engage with multiple API and KSM suppliers across different regions to reduce dependency on a single source.

• Strengthen Quality Assurance: Implement stringent quality control measures and conduct regular audits to ensure compliance with international standards.

• Monitor Geopolitical Developments: Stay informed about geopolitical events and assess their potential impact on the supply chain to proactively address risks.

• Invest in Domestic Production: Support initiatives like the PLI scheme to enhance domestic manufacturing capabilities for APIs and KSMs.

• Develop Contingency Plans: Establish robust contingency plans to address potential disruptions, including alternative sourcing strategies and inventory management.

RISK_LEVEL: MEDIUM