The US Food and Drug Administration (FDA) has approached Indian pharmaceutical manufacturers for urgent assistance in securing supplies of ifosfamide, a critical cancer medicine facing shortages in the United States, according to Indian government officials and a document reviewed by Mint.
The US FDA’s India office contacted the Indian Drug Manufacturers’ Association (IDMA) to identify companies capable of producing and supplying ifosfamide injections in 1-gram and 3-gram doses. The medicine is used in the treatment of testicular, bladder and lung cancers.
In a communication dated 19 June 2026, the IDMA informed its members that it had received a request from the US FDA seeking information from manufacturers currently producing ifosfamide or those with the capability to supply the drug for any market. The association is collecting details from potential suppliers, including manufacturing locations, FDA establishment identifier numbers, available product strengths, approved markets and the regulatory status of production facilities.
The request comes amid a shortage of ifosfamide in the US, where several dosages of the injectable drug were listed as unavailable, in limited availability or temporarily on backorder on the FDA’s drug shortages website as of 12 June. The shortage was attributed to requirements related to compliance with good manufacturing practices, with recovery previously estimated for October.
Indian pharmaceutical companies producing ifosfamide include Cipla, Zydus Lifesciences, Alkem Laboratories and GLS Pharma. GLS Pharma manufactures 1-gram and 2-gram vials of ifosfamide under the brand name Ipoget, according to information available on the company’s website.
The shortage was linked to a technical disruption at a contract manufacturing site operated by Baxter International Inc., the primary supplier of ifosfamide in the US, along with supply chain disruptions connected to the war in West Asia, according to officials. Baxter said production has resumed but remains at reduced capacity, leaving supply below current demand and resulting in limited availability throughout 2026.
A Baxter spokesperson told Mint that the company is working with its manufacturing partner, regulatory authorities and other stakeholders to restore supply. The company has also implemented a quota system to distribute available supplies among customers based on previous usage.
The US FDA has indicated that it is willing to consider products from Indian manufacturing facilities that are not registered with the agency, as well as medicines approved and marketed outside the US. According to the IDMA communication, preference will be given to products made at FDA-registered facilities, but facilities with a record of satisfactory regulatory compliance are also being considered.
“We have reached out to our members and are in the process of gathering information of manufacturers who may be manufacturing the products and have site approvals to be able to supply to target markets,” Viranchi Shah, national spokesperson of the IDMA, told Mint.
The search for alternative suppliers highlights the role of India’s pharmaceutical industry in global medicine supply chains. Commerce ministry data showed that India exported anti-cancer drugs worth ₹4,356.48 crore to the US in FY26, accounting for 38% of India’s total anti-cancer drug exports of ₹11,430 crore during the period.
India has around 10,500 pharmaceutical manufacturing units, with more than 350 registered and certified by the US FDA. The country’s pharmaceutical industry supplies about one-fifth of the world’s generic medicines and ranks third globally by volume. India exported medicines worth ₹75,803.50 crore to the US in FY26, representing about 35% of the country’s total medicine exports.
Officials from the US embassy, the FDA, India’s Ministry of External Affairs and the Pharmaceuticals Export Promotion Council of India had not responded to queries from Mint at the time of publication. Cipla, Alkem Laboratories, Zydus Lifesciences and GLS Pharma also did not respond to requests for comment.
