USFDA Taps Indian Pharma to Ease Ifosfamide Shortage, Zydus, Cipla Among Key Suppliers
New Delhi: Indian pharmaceutical companies are preparing to supply ifosfamide injection, an essential chemotherapy medicine, to the United States after the US Food and Drug Administration (USFDA) sought assistance from India to address an ongoing shortage of the drug.
The move follows a communication issued on June 18 by the US FDA's India office to Indian pharmaceutical industry bodies requesting information on manufacturers capable of supplying ifosfamide injection in 1 g and 3 g strengths. The agency is seeking to ensure uninterrupted availability of the cancer therapy in the US market.
According to industry sources, discussions between Indian manufacturers and the concerned authorities are progressing rapidly. Several leading Indian pharmaceutical companies are being considered to support the supply of the critical oncology medicine.Confirming the development, Viranchi Shah, National Spokesperson of the Indian Drug Manufacturers' Association (IDMA), said that Zydus, Cipla, Alkem, and Aurobindo Pharma's GLS are among the frontrunners as they already manufacture the molecule and have an established presence in the US market.
Shah clarified that the IDMA has informed the Indian government about manufacturers capable of producing the medicine but is not involved in any commercial discussions or negotiations between the companies and either the Indian or US governments. He said the association's role is limited to identifying interested and capable member companies, circulating the request among its members, and connecting suitable manufacturers with the government.
He further noted that the US authorities are moving quickly to evaluate the available options to ensure timely availability of the widely used chemotherapy drug, emphasizing that both speed and quality remain critical in responding to the shortage.
The communication from the US FDA also stated that the agency is interested in receiving information on manufacturers already producing, or capable of producing, ifosfamide injection for any market. In addition to products marketed in the United States, the FDA is also willing to consider products approved and marketed in other countries.
While the agency expressed a preference for medicines manufactured at US FDA-registered facilities, it also indicated that it would welcome information on products manufactured at facilities that are not FDA-registered, provided they have demonstrated a strong history of regulatory compliance.
According to a recent media report in ET Pharma, India has nearly 10,500 pharmaceutical manufacturing units, including more than 350 US FDA-registered facilities. The report also noted that India supplies nearly one-fifth of the world's generic medicines and ranks third globally by pharmaceutical production volume, reinforcing the country's position as a key partner in addressing global medicine shortages.
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