USFDA Seeks Indian Drugmakers’ Help To Tackle Ifosfamide Cancer Drug Shortage

The US Food and Drug Administration (USFDA) has approached Indian pharmaceutical manufacturers to help address a shortage of ifosfamide injection, a generic chemotherapy medicine used in the treatment of cancers such as testicular, bladder and lung cancer, according to a report.

The regulator contacted companies through the Indian Drug Manufacturers' Association (IDMA) and sought details of manufacturers that can immediately supply ifosfamide injection in 1-gram and/or 3-gram strengths.

In a communication dated 19 June 2026, the IDMA informed its members that the USFDA India Office had requested assistance in identifying manufacturers capable of supplying the drug to ease an ongoing shortage in the US market.

FDA Open To Non-Registered Facilities

The US regulator has indicated flexibility in sourcing supplies as it seeks to stabilise the availability of the cancer treatment. According to the IDMA communication, preference will be given to products manufactured at USFDA-registered facilities.

However, the agency is also willing to consider supplies from manufacturing sites that are not registered with the US regulator if they have a satisfactory compliance record.

The FDA is additionally interested in products that are approved and marketed outside the United States. The IDMA said that preference will be given to products manufactured at US FDA-registered facilities. It also added that the US FDA has expressed interest in information from facilities that may not be FDA-registered but have a demonstrated history of satisfactory regulatory compliance.

Supply Disruptions Behind Shortage

The shortage has been linked to a technical disruption at a contract manufacturing site of Baxter International. Supply chain disruptions arising from the West Asia conflict have also affected availability. The report said supplies are expected to remain constrained through 2026.

No specific Indian company was identified in the communication. However, listed pharmaceutical companies with oncology and injectable drug capabilities could remain on investors’ radar. These include Cipla, Zydus Life Sciences, Alkem Laboratories, Aurobindo Pharma and Dr. Reddy’s Laboratories.

Aurobindo Pharma has a significant injectable medicines business, while Dr. Reddy’s has operations spanning oncology active pharmaceutical ingredients (APIs) and formulations. Cipla also maintains a presence in oncology injectables.

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India’s Role In Global Generic Medicines

India has around 10,500 pharmaceutical manufacturing units, with more than 350 facilities registered and certified by the USFDA. The country supplies roughly one-fifth of the world’s generic medicines and ranks third globally by volume.

Commerce ministry data showed India exported medicines worth ₹75,803.50 crore to the US in FY26. The US accounted for nearly 35% of India’s total pharmaceutical exports of ₹2.18 trillion during the year.

Sources:

Moneycontrol

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