Update on Nalcrom Supplies

The UK Mastocytosis Support Group has received the following statement from Sanofi, the licensed supplier of Nalcrom (sodium cromoglycate capsules) in the UK:

“Following queries from The UK Mastocytosis Support Group regarding the situation and future availability of Nalcrom (sodium cromoglicate), Sanofi would like to clarify that the use of Nalcrom for the treatment of mastocytosis is outside the licensed indication stated in the Summary of Product Characteristics (SmPC).

There is currently supply of sodium cromoglicate available in the UK. Primarily due to historical increases in demand, Sanofi has experienced challenges in maintaining a steady supply of sodium cromoglicate in the UK to date. In addition to this, Sanofi is currently unable to increase or bring production forward due to the availability of the active pharmaceutical ingredient (API) used to manufacture this medicine.

Availability of API used to manufacture sodium cromoglicate is limited due to the impact of COVID-19 in Singapore, where increases in the number of cases and government restrictions on movement have impacted the plant’s ability to engage contractors who are important for production.

Sanofi does therefore anticipate supply issues in the UK until November 2021, with supply of sodium cromoglicate improving towards the end of this year. We engage the Department of Health and Social Care (DHSC) and other health authorities regularly on the situation to mitigate the impact of any shortages.

Should patients have any concerns about their treatment, they should speak to their clinician about treatment options. Should patients have issues obtaining supply from their pharmacist, the pharmacist can contact Sanofi Customer Services (+44 (0)800 854 430)) for support.

Job code: MAT-GB-2103475 (v1.0) Date of preparation: August 2021