How India Exports Lomustine to the World

In the United States, lomustine is approved under the brand name Gleostine. According to the FDA's Orange Book, there are no approved Abbreviated New Drug Applications (ANDAs) for generic versions of lomustine, indicating a lack of generic competition in the U.S. market. As of March 2026, there are no import alerts or restrictions specific to lomustine, facilitating its importation into the U.S. Given the 74 active Indian exporters, this presents a significant opportunity for Indian manufacturers to supply lomustine to the U.S. market, provided they comply with FDA regulations, including Good Manufacturing Practices (GMP) and potential New Drug Application (NDA) requirements.

In the European Union, lomustine is authorized for marketing under various national procedures. The European Medicines Agency (EMA) conducted a Periodic Safety Update Report Single Assessment (PSUSA) for lomustine, concluding in November 2023, which resulted in a variation to the marketing authorization. (ema.europa.eu) This underscores the importance of ongoing pharmacovigilance and compliance with EU GMP standards for manufacturers. In the United Kingdom, post-Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the authorization of medicines, and lomustine remains subject to national regulatory requirements.

Lomustine is included in the World Health Organization's (WHO) Model List of Essential Medicines, highlighting its critical role in treating specific cancers. Manufacturers must ensure that lomustine formulations meet international pharmacopoeial standards, including those of the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), to ensure global acceptance and compliance.

In India, lomustine is classified as a Schedule H drug under the Drugs and Cosmetics Act, requiring a prescription for dispensing. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for lomustine, 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 export regulations.

The primary patents for lomustine have expired, leading to the availability of generic versions in various markets. However, the absence of approved ANDAs in the U.S. suggests limited generic competition, potentially due to regulatory or market barriers.

In November 2023, the EMA concluded a PSUSA for lomustine, resulting in a variation to its marketing authorization, emphasizing the need for continuous safety monitoring. (ema.europa.eu) In July 2023, the EMA reported the withdrawal of a marketing authorization application for Lutholaz (pegfilgrastim) due to GMP certification issues, highlighting the critical importance of compliance with EU GMP standards for market approval. (ema.europa.eu) In June 2025, the EMA granted orphan designation to a new compound for the treatment of acute myeloid leukemia, reflecting ongoing developments in oncology therapeutics. (ema.europa.eu) In September 2025, the EMA adopted a positive opinion for a variation to the marketing authorization of Lunsumio, introducing a new route of administration and pharmaceutical form, indicating advancements in treatment modalities. (ema.europa.eu) In August 2023, the EMA reported the withdrawal of the marketing authorization application for Lutholaz due to GMP certification issues, underscoring the importance of manufacturing compliance. (ema.europa.eu)

These developments underscore the dynamic nature of the pharmaceutical regulatory landscape and the necessity for manufacturers to stay abreast of regulatory changes, maintain stringent quality standards, and engage in continuous pharmacovigilance to ensure market access and compliance.

Lomustine, an antineoplastic agent, relies on Active Pharmaceutical Ingredients (APIs) that are predominantly manufactured in India. However, the production of these APIs is heavily dependent on Key Starting Materials (KSMs), many 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, while 16% come exclusively from India. This concentration poses a significant risk, as any disruption in China's supply chain can directly impact the availability of essential KSMs, thereby affecting API production in India.

Recent events have underscored this vulnerability. In March 2026, the closure of the Strait of Hormuz following geopolitical tensions led to significant disruptions in the supply of raw materials to Asia's chemical industry. Facilities that rely on Middle Eastern naphtha experienced procurement delays, resulting in force majeure declarations and production cutbacks. Such disruptions highlight the fragility of the supply chain for critical pharmaceutical ingredients like Lomustine.

Our proprietary trade data indicates that the top five Indian exporters of Lomustine account for 41.4% of the total export value, with 3S Corporation leading at a 13.6% share. This level of supplier concentration introduces a single-source risk, where disruptions affecting a major exporter can have disproportionate impacts on the global supply chain.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at reducing dependency on imports for 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, which are crucial for antibiotic production. While these initiatives are steps toward self-reliance, their impact on reducing supplier concentration in the Lomustine supply chain remains to be seen.

The Strait of Hormuz and the Red Sea are critical chokepoints for global shipping. In March 2026, the closure of the Strait of Hormuz due to escalating conflicts led to significant disruptions in the supply of raw materials to Asia's chemical industry. Facilities that rely on Middle Eastern naphtha experienced procurement delays, resulting in force majeure declarations and production cutbacks. Such disruptions can have cascading effects on the pharmaceutical supply chain, including the production and export of drugs like Lomustine.

Additionally, the U.S. Food and Drug Administration (FDA) has been monitoring supply chain vulnerabilities. In January 2025, the FDA released a list of antiviral medications and their availability for the 2024-2025 influenza season, highlighting the importance of proactive measures to address potential shortages. While Lomustine was not specifically mentioned, the broader context underscores the need for vigilance in managing supply chain risks for critical medications.

• Diversify KSM Sourcing: Identify and qualify alternative suppliers for Key Starting Materials to reduce dependency on single-source countries, particularly China.

• Enhance Supplier Audits: Implement rigorous auditing processes for existing and potential suppliers to ensure compliance with quality standards and assess their resilience to disruptions.

• Invest in Local Manufacturing: Leverage government incentives like the PLI scheme to establish or expand domestic production facilities for critical APIs and KSMs.

• Develop Contingency Plans: Establish comprehensive risk management strategies, including maintaining strategic stockpiles and identifying alternative logistics routes to mitigate the impact of geopolitical disruptions.

• Strengthen Regulatory Collaboration: Engage with regulatory bodies such as the FDA and EMA to stay informed about potential shortages and collaborate on proactive measures to ensure a stable supply of essential medications.

RISK_LEVEL: HIGH