How India Exports Daratumumab to the World

As of March 2026, the FDA has approved daratumumab for multiple indications. The initial approval was granted on November 16, 2015, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to these agents. Subsequent approvals have expanded its use to various combination therapies and earlier lines of treatment.

Regarding generic competition, as of March 2026, there are no approved Abbreviated New Drug Applications (ANDAs) for generic versions of daratumumab listed in the FDA's Orange Book. This indicates that the market remains exclusive to the branded product, Darzalex.

The export data from India reveals that 36 active Indian exporters have shipped daratumumab to the United States, among other destinations. This underscores the importance of ensuring compliance with FDA regulations, including Good Manufacturing Practices (GMP) and proper labeling, to facilitate market entry and maintain product integrity.

In the European Union, the European Medicines Agency (EMA) granted a conditional marketing authorization for Darzalex on May 20, 2016, for the treatment of relapsed and refractory multiple myeloma. (ema.europa.eu) This authorization was converted to a standard marketing authorization on April 28, 2017. The UK, having exited the EU, follows its own regulatory procedures through the Medicines and Healthcare products Regulatory Agency (MHRA), which has aligned with EMA's decisions regarding daratumumab.

Compliance with EU and UK GMP requirements is mandatory for manufacturers exporting to these markets. This includes adherence to guidelines on quality management, personnel, premises, equipment, documentation, production, quality control, and self-inspection.

As of March 2026, daratumumab is not listed in the World Health Organization's Model List of Essential Medicines. However, it is essential for exporters to ensure that their products meet international pharmacopoeia standards, including those set by the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). Adherence to these standards ensures product quality and facilitates acceptance in various international markets.

In India, daratumumab is classified under Schedule H of the Drugs and Cosmetics Rules, indicating that it is a prescription drug requiring oversight by a registered medical practitioner. The National Pharmaceutical Pricing Authority (NPPA) has not set a ceiling price for daratumumab, allowing market-driven pricing. For exports, obtaining a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) is necessary, ensuring compliance with export regulations and monitoring.

Daratumumab's primary patents are held by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson. The initial FDA approval in November 2015 granted a period of market exclusivity, which has since expired. However, as of March 2026, no generic versions have been approved, indicating that patent protections or other market factors continue to limit generic competition.

In June 2025, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a new indication for Darzalex as monotherapy for the treatment of adult patients with smouldering multiple myeloma at high risk of progressing to multiple myeloma. (ema.europa.eu)

In the United States, the FDA granted orphan drug designation to daratumumab and hyaluronidase-fihj (Darzalex Faspro) for the treatment of light-chain (AL) amyloidosis on October 6, 2020, with marketing approval following on January 15, 2021.

These developments reflect the ongoing expansion of daratumumab's therapeutic indications and its sustained relevance in the treatment of hematologic malignancies.

In summary, daratumumab's regulatory landscape is characterized by established approvals in major markets, ongoing compliance requirements, and a dynamic environment influenced by patent statuses and emerging clinical data. Exporters must navigate these factors to ensure successful market entry and sustained product availability.

The production of Daratumumab relies on specific Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). Historically, India has depended heavily on imports for these critical components, particularly from China, which controls a significant portion of the global KSM supply. This dependency poses a risk of supply disruptions due to geopolitical tensions or trade restrictions. To mitigate this, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at boosting domestic manufacturing of critical KSMs and APIs. As of March 2025, the scheme has led to the creation of domestic manufacturing capacity for 25 identified items, resulting in import savings of ₹1,362 crore. However, the effectiveness of these measures in fully addressing the dependency on imported raw materials remains to be seen.

The export market for Daratumumab from India is relatively concentrated. The top five exporters account for 59.0% of the total export value, with VAMA LIFECARE PRIVATE LIMITED leading at 20.1%. Such concentration increases the risk of supply disruptions if any of these key suppliers face operational challenges. The PLI scheme aims to diversify and strengthen the supplier base by encouraging more manufacturers to enter the market. As of December 2025, the Department of Pharmaceuticals extended the application deadline for the PLI scheme to January 16, 2026, to attract additional participants. While this initiative is promising, its success in reducing supplier concentration will depend on the actual uptake and production outcomes of new entrants.

Global shipping routes, including the Red Sea and the Strait of Hormuz, are critical for the transportation of pharmaceuticals. Any geopolitical tensions or conflicts in these regions can lead to shipping delays and increased costs. Additionally, ongoing U.S.-China trade tensions may impact the availability and pricing of raw materials sourced from China. While there have been no specific FDA or EMA shortage alerts for Daratumumab as of March 2026, the interconnected nature of global supply chains means that disruptions in one area can have cascading effects. Therefore, continuous monitoring of geopolitical developments is essential to anticipate and mitigate potential risks.

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

• Strengthen Domestic API Production: Leverage the PLI scheme to enhance the production capacity of critical APIs and KSMs within India, thereby reducing dependency on imports.

• Monitor Geopolitical Developments: Establish a dedicated team to track geopolitical events that could impact shipping routes and raw material availability, enabling proactive risk management.

• Develop Alternative Shipping Strategies: Identify and establish alternative shipping routes and logistics partners to ensure continuity in case of disruptions in primary channels.

• Enhance Inventory Management: Maintain strategic stockpiles of critical raw materials and finished products to buffer against short-term supply disruptions.

RISK_LEVEL: MEDIUM