Pharmaceutical company Besins Healthcare yesterday (September 21) announced that it has this week launched a new factory producing hormone replacement therapy (HRT) drugs in Zaragoza, Spain.

Besins said that the new “state-of-the-art” facility comes after “a significant rise” in UK demand led to “some unforeseen shortages in supply and short-term supply interruptions”.

Read more: UPDATED: Serious shortage protocol issued for HRT drug Utrogestan

This prompted the company to develop an “enormous increase” in its manufacturing capacity, it added.

The factory will initially produce estrogen gel (Oestrogel) and progesterone capsules (Utrogestan 100mg and 200mg), it added.

Besins announced that new HRT supplies will be available by the middle of 2024, pending regulatory approval.

 

30% boost

 

The specialist HRT manufacturer said that the development of its factory showed a “commitment to scaling up and future-proofing” HRT supplies for the UK.

It claimed that its new factory, opened just 18 months after construction began in May 2022, will boost “global and European manufacturing output by 30%”.

Read more: Pharma company to boost HRT production with new manufacturing site

It comes after Besins acquired a pharmaceutical manufacturing site in Belgium in June last year, also aimed at helping it increase its supply of HRT products such as Oestrogel to the UK. 

At the time, it described the site as “a strategic purchase” that will help it “increase production of its own products, offering greater efficiencies and greater integration into the company’s supply line”.

 

HRT shortages latest

 

It comes as pharmacist and MP Taiwo Owatemi raised concerns in a Westminster Hall debate last week that while the EU had invested “about £20 billion” in generics manufacturing since Brexit, the UK had invested nothing.

Ms Owatemi warned that UK generics manufacturers were “unable to compete” with their continental rivals.

HRT shortages in particular have plagued patients and pharmacists alike for some time.

Read more: Wholesalers banned from exporting or hoarding progesterone

In May, C+D reported that the Department of Health and Social Care (DH) had issued a serious shortage protocol (SSP) for Utrogestan 100mg capsules, saying that it expected the supply of Utrogestan to be “intermittent” until late 2023.

At the time, the DH reported that Besins was "frequently" making deliveries of Utrogestan but had "struggled to meet rising demand".

The SSP was expected to lift on August 18 but it was extended and is now set to expire on September 29, according to the NHS Business Services Authority (NHSBSA).

Read more: Is our medicines supply chain fit for purpose?

Meanwhile, Besins had said in October that it had “sufficient stock of [its] HRT range with ongoing regular supplies”, in a C+D analysis of HRT supplies.

It said at the time that its “efforts” to increase supply seemed to be “making a difference”, adding that the DH’s introduction of SSPs “may have also helped to manage the supply and demand of HRT products”. 

Last September, C+D reported that a DH taskforce dedicated to easing the supply of HRT drugs was set to be disbanded, despite reports at the time from pharmacists and menopause campaigners that some products were still difficult to acquire.