Generic sterile injectables (the 2023 platinum shortage)

Generic sterile injectables are made by dissolving the API, filtering it through a sterilising filter and filling vials aseptically in a grade A environment, or filling and then terminally sterilising by autoclave where the molecule tolerates heat, then inspecting every vial for particles. The margins are thin, the plants are expensive to keep in compliance, and a single sterility or particulate failure can shut a line for months, so the number of suppliers for any one drug has fallen to two or three. Cytotoxics add containment for operator safety.

The worked example is the platinum shortage of 2023. After an FDA inspection of Intas Pharmaceuticals' Ahmedabad plant in late 2022 found serious quality and data-integrity problems, the company halted production there; it had supplied a large share of US cisplatin and carboplatin through its Accord Healthcare arm. Cisplatin went into shortage in February 2023 and carboplatin followed in the spring. A June 2023 survey by the National Comprehensive Cancer Network found most of its member centres short of carboplatin and a majority short of cisplatin, with clinics substituting regimens, reducing doses or prioritising curative patients. The FDA allowed temporary importation of unapproved cisplatin from Qilu Pharmaceutical in China and worked with other makers to raise output; supply recovered gradually through 2024. Methotrexate, fluorouracil, cytarabine and vincristine have all had their own shortages recorded on the FDA and ASHP pages linked below, and the responses (Civica Rx, hospital stockpiles, a proposed strategic reserve) are covered in the shortage response record.