Intas Pharmaceuticals
Indian generics maker; its Accord/Intas units made roughly half of US cisplatin/carboplatin until a 2023 FDA inspection halt triggered a national shortage.
pharmaceutical · input
Finished-dose sterile injectable vials of platinum-based and taxane chemotherapy agents used in cancer infusion centers and hospitals: cisplatin injection (1mg/mL), carboplatin injection (10mg/mL), paclitaxel injection (6mg/mL), oxaliplatin injection, and gemcitabine injection. Distinct from the APIs — these are the finished, sterile-filled vials ready for patient administration. Market concentration: Pfizer/Hospira, Hikma (Columbus OH), Fresenius Kabi, Teva, and Mylan/Viatris supply the vast majority of US hospital volume. The 2023 Intas API shortage cascaded into these finished-dose vials as well.
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Source countries
6
Companies
1
Goods affected
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Claims on record
What depends on it
1 essential American goods rely on generic oncology injectable vials (cisplatin, carboplatin, paclitaxel) somewhere upstream in their supply chain.
Who makes it
6 companies produce generic oncology injectable vials (cisplatin, carboplatin, paclitaxel).
Indian generics maker; its Accord/Intas units made roughly half of US cisplatin/carboplatin until a 2023 FDA inspection halt triggered a national shortage.
Sterile injectables (Hospira) including propofol/anesthetics.
Hikma Pharmaceuticals PLC (Amman Jordan; London Stock Exchange: HIK; NYSE: WHL; ~$3.1B revenue) is a major US generic injectable pharmaceutical manufacturer primarily through its Hikma Pharmaceuticals USA (formerly Roxane Laboratories) division acquired in 2016 for $2.65B. US injectable manufacturing: Columbus OH (Hikma Columbus — formerly Roxane; large sterile injectable campus) and Eatontown NJ (Hikma Eatontown). Hikma produces morphine sulfate injection, fentanyl citrate injection, and hydromorphone HCl injection as Schedule II controlled substance generics for US hospitals. Hikma is the largest pure-play injectable pharmaceutical company by volume in the US generics market. Jordan-headquartered and London-listed but the business is majority US generic injectables — an unusual corporate structure for what is effectively a critical US hospital drug supplier.
Teva Pharmaceutical Industries Ltd. (Tel Aviv Israel; NYSE: TEVA; ~$15.9B revenue 2023; world's largest generic pharmaceutical company by revenue) is a significant manufacturer and distributor of generic carboplatin injectable in the US market. Teva's API division (TAPI) and finished-dose operations supply generic oncology products including carboplatin to US hospital pharmacies. Teva experienced its own FDA enforcement actions in this period — in 2022, Teva's Irvine California facility was shut down due to contamination and sterilization failures, causing a separate streptozocin (pancreatic cancer drug) shortage. Teva's manufacturing is concentrated in Israel, India, and Eastern Europe, with US finished-dose manufacturing in North America. Teva's scale as the world's largest generic company makes it a critical backstop supplier when primary market participants face disruptions.
US generic pharmaceutical company (spun off from Pfizer/Mylan 2020); first FDA approval for generic Restasis (cyclosporine ophthalmic emulsion) February 2022.