pharmaceutical · input
Beta-2 adrenergic agonist; world's most-dispensed inhaler active ingredient. Used in Ventolin (GSK), Proventil, ProAir and hundreds of generics. Must be micronized to 1–5 µm for pMDI use. Principal manufacturers include GSK (Montrose, Scotland), Cipla (India), and Chinese API producers. The 2023 US albuterol nebulizer solution shortage (Akorn bankruptcy) highlighted single-facility concentration risk.
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Source countries
5
Companies
1
Goods affected
0
Claims on record
What depends on it
1 essential American goods rely on salbutamol (albuterol) api somewhere upstream in their supply chain.
Where it comes from
Share of global supply, by country.
| Country | Share of supply |
|---|---|
| INIndia | 45% |
| GBUnited Kingdom | 28% |
| CNChina | 15% |
| ILIsrael | 8% |
Who makes it
5 companies produce salbutamol (albuterol) api.
UK pharmaceutical company; sole manufacturer and formulator of AS01B adjuvant system (QS-21 + MPL in liposomes); used in Shingrix (herpes zoster vaccine, $4B+ annual revenue) and RTS,S/Mosquirix (malaria vaccine); retaining AS01E adjuvant supply even as malaria vaccine manufacturing transfers to Bharat Biotech
Indian generic pharmaceutical company and the world's largest generic inhaler manufacturer by volume. Pioneer of generic salbutamol inhalers in India (1978). Manufactures generic pMDIs at scale. Received FDA final approval for generic Proventil HFA. Critical supplier during COVID-19 when global inhaler demand surged.
Indian pharmaceutical company (NSE: SUNPHARMA, HQ Mumbai; ~₹600B revenue); world's fourth-largest specialty generic pharmaceutical company and India's largest pharma company by market cap. Sun Pharma manufactures salbutamol sulfate API and finished albuterol inhalers (pMDI and nebulizer solution) at multiple Indian manufacturing sites, supplying US and global generic markets through its Taro Pharmaceutical US subsidiary. Sun Pharma was founded in 1983 by Dilip Shanghvi, who started with just five pharmaceutical products and a single employee; today Sun Pharma employs 36,000 people and operates 43 manufacturing sites globally. Sun Pharma's founder Dilip Shanghvi is now one of India's wealthiest individuals — his journey from a $1M startup to a $30B market cap company in 40 years is one of the defining business stories of India's pharmaceutical sector rise.
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.
Former American specialty pharmaceutical company (HQ Lake Forest IL; filed Chapter 7 bankruptcy May 2023 and immediately shut down all operations); was the dominant US manufacturer of albuterol sulfate nebulizer solution (the liquid form of albuterol administered via nebulizer machine, commonly used for infants, young children, and patients unable to use pMDI inhalers). At the time of its bankruptcy and immediate shutdown, Akorn supplied approximately 50-60% of the US albuterol nebulizer solution market. The abrupt cessation of Akorn's manufacturing operations in May 2023 triggered an immediate national albuterol nebulizer shortage declared by FDA — hospitals reported being unable to source adequate albuterol nebulizer vials for pediatric asthma emergencies, ICU patients, and home nebulizer users. The shortage lasted several months and required FDA to exercise enforcement discretion to allow foreign-manufactured albuterol products to be imported. Akorn's collapse is the canonical recent case study of single-facility concentration creating a national pharmaceutical shortage. Akorn is included in the supply company record for historical documentation despite being defunct.
