Tacrolimus

For the last few years, GSK has been dismantling its underutilized antibiotics plant in Ulverston. It will close the plant in June of next year as a contract to make penicillins for Sandoz expires. With the expiration of a contract to produce antibiotic medicines for Sandoz, GSK will shutter a 75-year-old manufacturing facility in its home country. The U.K. pharma will close its plant in Ulverston in June of next year, terminating the employment of approximately 100. BBC reported the decision over the weekend.The layoffs—including 200 at another GSK manufacturing site in Barnard Castle—were announced in 2021.When Sandoz paid $500 million to acquire the rights to sell GSK’s trio of established cephalosporin antibiotics—Zinnat, Zinacef and Fortum—in more than 100 markets around the world, it said it would eventually take over production of the penicillins. Sandoz’s antibiotics production is centered at its site in Kundil, Austria. With the deal coming during the COVID-19 pandemic, Sandoz was looking to beef up its antibiotics portfolio. It also fit into GSK CEO Emma Walmsley’s strategy to focus on innovative medicines and vaccines and divest other assets. On Monday, GSK confirmed the planned closure of the Ulverston plant. Over the last few years, the company has been dismantling the under-used facility.“In 2021, we said that, in the absence of alternatives, we would close our cephalosporins manufacturing operations—including our site at Ulverston—once our contract manufacturing agreement with Sandoz ended in 2025,” a GSK spokesperson wrote in an email. “We understand this has been a difficult and uncertain period for our people at Ulverston. As ever, our first priority is to support them as much as we can.” The GSK spokesperson added that the company is making a 2 million pound sterling ($2.6 million) donation to the community. GSK also is in “in-depth discussions” with parties that are interested in the land at the Ulverston site.There is no plan to close the campus at Barnard Castle, where “the vast majority” of employees are unaffected, the GSK spokesperson said, adding that some of the company’s “most innovative medicines,” are produced at the site.

To address an ongoing shortage of ADHD drugs, the Drug Enforcement Administration has increased the production quota on Takeda's Vyvanse and its generic versions by 24%. Less than four months after Teva’s Adderall was erased from the FDA shortage list, supply problems with another attention-deficit/hyperactivity disorder (ADHD) treatment, Takeda’s Vyvanse and its generic versions, are such that the U.S. Drug Enforcement Administration (DEA) has increased (PDF) production quotas on the drug by 24%.The move comes eight weeks after an FDA request to the DEA to bump up production limits. As Schedule 2 controlled substances, Vyvanse (lisdexamfetamine) and Adderall (amphetamine/dextroamphetamine) are subject to DEA limitations that help prevent them from being abused.The DEA has raised the aggregate production quota on lisdexamfetamine by 6,236 kilograms, according to a final order set to be published Thursday in the Federal Register. Of that figure, 1,558 kg has been allocated to domestic demand for medications, while the remaining 4,678 kg addresses foreign demand for the products.“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” the DEA wrote in its notice. Because the drugs are so tightly controlled, there is a ripple effect when one has a supply issue. Shortages of ADHD drugs have persisted since the summer of 2022 when a labor problem on Teva’s packaging line reduced the supply of Adderall. That issue then triggered increased demand and supply issues with most of the 11 companies making generic versions of Adderall, including Sandoz, Amneal and Sun Pharma. Then, in June of last year, Takeda reported in a statement on its website that it was experiencing “low inventory” for Vyvanse brought on by increased demand and a manufacturing delay. In addition, the timing of Vyvanse's shortage raises a question around the economics of producing the medicine in the aftermath of generic launches. Takeda reported its Vyvanse supply shortfall last June, and the first U.S. generics ⁠launched two months later. Lawmakers and industry watchers have repeatedly flagged that ⁠economic factors can drive drug shortages when companies don't see a potential profit motive in dedicating their manufacturing equipment to low-margin—or even loss-making—products. Meanwhile, on the DEA's manufacturing allocation, the agency last summer committed to “reviewing and improving” the quota process. In 2022, that limit was not met, and drugmakers sold only 70% of their allotted quota for the year, making for some 1 billion extra doses that could have been produced, the FDA and the DEA revealed in a joint letter (PDF).At the time, the agencies said they had called on manufacturers to confirm production increases and asked that those that opt to no longer produce the meds “relinquish” their remaining quota so the DEA can redistribute it.