How India Exports Pomalidomide to the World

In the United States, pomalidomide is marketed under the brand name Pomalyst. The FDA granted orphan drug designation for pomalidomide for the treatment of multiple myeloma on January 15, 2003, with marketing approval following on February 8, 2013. Additionally, on April 4, 2018, the FDA designated pomalidomide for the treatment of Kaposi sarcoma, with approval granted on May 14, 2020.

As of March 2026, the FDA Orange Book lists multiple approved Abbreviated New Drug Applications (ANDAs) for pomalidomide, indicating the presence of generic competition. The regulatory pathway for pomalidomide in the U.S. involves stringent requirements, including compliance with the Risk Evaluation and Mitigation Strategy (REMS) due to its teratogenic potential. Given the presence of 108 active Indian exporters and 190 buyers, with a repeat buyer rate of 57.9%, the U.S. market presents significant opportunities for Indian manufacturers.

In the European Union, the European Medicines Agency (EMA) granted marketing authorization for pomalidomide under the brand name Imnovid on August 5, 2013. The authorization was based on its efficacy in combination with dexamethasone for treating adult patients with relapsed and refractory multiple myeloma. (ema.europa.eu)

The United Kingdom, following its departure from the EU, has adopted similar regulatory standards through the Medicines and Healthcare products Regulatory Agency (MHRA). Manufacturers exporting pomalidomide to these regions must adhere to EU Good Manufacturing Practice (GMP) guidelines, ensuring product quality and safety.

Pomalidomide is included in the 22nd edition of the WHO Model List of Essential Medicines, underscoring its importance in treating multiple myeloma. While specific WHO Prequalification for pomalidomide is not documented, adherence to international pharmacopoeia standards such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP) is essential for global market acceptance.

In India, pomalidomide 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 pomalidomide, allowing market-driven pricing. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with international regulations and prevent misuse.

The primary patents for pomalidomide have expired in major markets, leading to increased generic competition. This is evidenced by the presence of multiple generic versions approved by regulatory agencies such as the FDA and EMA. The competitive landscape necessitates that Indian exporters focus on quality and regulatory compliance to maintain market share.

In June 2025, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a new indication for Sarclisa, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma. (ema.europa.eu)

In November 2024, the CHMP recommended a new indication for Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. (ema.europa.eu)

In April 2025, the EMA granted conditional marketing authorization for Lynozyfic (linvoseltamab) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies. (ema.europa.eu)

In January 2024, the EMA recommended the non-renewal of the marketing authorization for Blenrep, a multiple myeloma medicine, due to its failure to demonstrate effectiveness compared to pomalidomide plus low-dose dexamethasone. (ema.europa.eu)

In December 2023, the EMA adopted a positive opinion for Pomalidomide Viatris, a generic version of pomalidomide, indicating the growing acceptance and availability of generic alternatives in the European market. (ema.europa.eu)

These developments highlight the dynamic nature of the multiple myeloma treatment landscape and the importance of staying abreast of regulatory changes and market trends.

Pomalidomide, an antineoplastic agent, is primarily manufactured in India. However, the production of its Active Pharmaceutical Ingredient (API) heavily relies on Key Starting Materials (KSMs) and intermediates imported from China. China controls approximately 70–80% of the global KSM supply and 60–70% of intermediates, making it a dominant player in the pharmaceutical raw material market. This dependency exposes the Indian pharmaceutical industry to potential supply chain disruptions stemming from geopolitical tensions, trade disputes, or regulatory changes in China.

In response to this vulnerability, the Indian government launched the Production Linked Incentive (PLI) scheme in October 2024, aiming to bolster domestic production of critical APIs and KSMs. Two greenfield plants were inaugurated under this initiative to manufacture essential molecules like Penicillin G and 6-Aminopenicillanic acid (6-APA), which are crucial for antibiotic production. While these efforts signify progress, the PLI scheme's focus has been primarily on antibiotics, and its impact on the production of APIs for drugs like Pomalidomide remains limited.

Our proprietary trade data from 2022 to 2026 indicates a high supplier concentration in the export of Pomalidomide from India. The top five exporters account for 70.4% of the total export value, with MSN Laboratories Private Limited alone contributing 66.9% ($3.0 million). This significant concentration poses a single-source risk, as any operational or regulatory issues affecting these key suppliers could disrupt the global supply chain for Pomalidomide.

The PLI scheme, initiated in October 2024, aims to reduce India's dependence on imported APIs and KSMs by incentivizing domestic production. While this initiative has led to the establishment of new manufacturing units, its primary focus has been on antibiotics and other essential drugs. The scheme's impact on diversifying the supplier base for Pomalidomide remains to be seen, and further efforts may be required to address the specific risks associated with this drug's supply chain.

Recent geopolitical tensions have significantly impacted global shipping routes critical to pharmaceutical supply chains. In March 2026, the closure of the Strait of Hormuz due to escalating conflicts led to a surge in crude oil prices and disrupted global supply chains. This closure halted shipments and increased the risk of global supply delays, affecting various industries, including pharmaceuticals. (ibtimes.sg)

Additionally, tensions in the Red Sea region have prompted shipping companies to reroute vessels, leading to increased transit times and costs. These disruptions pose a risk to the timely delivery of pharmaceutical products, including Pomalidomide, to international markets. While no specific shortage alerts for Pomalidomide have been issued by the FDA or EMA as of March 2026, the potential for future disruptions remains a concern.

• Diversify Supplier Base: Encourage the development of additional domestic manufacturers for Pomalidomide to reduce reliance on a limited number of suppliers.

• Enhance Domestic Production of KSMs: Expand the PLI scheme to include incentives for producing KSMs and intermediates essential for Pomalidomide, decreasing dependence on Chinese imports.

• Strengthen Supply Chain Monitoring: Implement robust tracking systems to identify and address potential disruptions in the supply chain promptly.

• Develop Alternative Shipping Routes: Collaborate with logistics partners to establish contingency plans that mitigate the impact of geopolitical tensions on shipping lanes.

• Engage in Strategic Stockpiling: Maintain adequate reserves of Pomalidomide and its raw materials to buffer against short-term supply disruptions.

RISK_LEVEL: MEDIUM