Manufacturing

In an update to its strategy for dealing with US tariffs, Korea’s Celltrion has revealed actions taken so far, as well as outlining plans to consider moving “swiftly” to secure US manufacturing for APIs if circumstances demand.

Momentum is building around the European Commission’s race to propose a Critical Medicines Act, which aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU.

Speaking during its financial Q3 earnings call, Sun Pharma’s management has again pooh-poohed any idea of jumping into biosimilars in the near future, while providing updates on its trio of stricken Indian manufacturing facilities.

Slovenian firm Krka addressed concerns about potential capacity restrictions during its recent preliminary annual earnings call, stating that it was continuing to work with partners while maintaining its own investments to meet its goals.

Celltrion may consider establishing or acquiring US manufacturing facilities as well as securing more US inventory and shifting its focus onto drug substance rather than drug product imports, the Korean biosimilars giant has suggested, as it sought to assuage investor concerns over pharmaceutical tariffs announced by US president Donald Trump.

Biocon Biologics has announced a change in regulatory status for a manufacturing plant in Malaysia that could pave the way for a pair of long-awaited FDA biosimilar approvals, after similar positive news for an Indian site late last year.

Viatris has told investors it will incorporate any potential future financial impact into its soon-to-be-released 2025 guidance ranges, after the firm’s oral finished dose manufacturing facility in Indore, India, was slapped with a US Food and Drug Administration import alert and warning letter.

Aurobindo is looking to finally put a key manufacturing disruption behind it in Europe, enabling the firm to gain traction for some of its early biosimilar filings.

Attended by several government delegates, the opening of the multi-million dollar antibiotic plant highlighted the Indian government’s ongoing policy to bolster domestic pharmaceutical manufacturing.

Biocon Biologics chief commercial officer for advanced markets Matt Erick says the firm is a “quiet giant” in the biosimilars space, but speaks up about the firm’s plans to grow its business in Europe, explore in-licensing as well as in-house development, and capitalize on the upcoming loss of exclusivity for Stelara in the US.

Alkem and Torrent said the tested batches were not manufactured by them, as a recent CDSCO report pinned their drugs as “not of standard quality”. Meanwhile, other firms informed the agency themselves about counterfeit drugs on the market.

Amneal will lend its expertise in product development and manufacturing under a collaboration with obesity and metabolic disorders start-up Metsera – the latest in a recent string of deals involving the highly sought-after GLP-1 analogs.

The US FDA has issued a Form 483 to Granules India, with six observations, spanning document and vent mismanagement to bird droppings and rust.

Coherus BioSciences has warned that a supply interruption is coming for its Udenyca biosimilar pegfilgrastim rival to Neulasta in the US, after a CMO used for final packaging revealed capacity constraints.

Zydus Lifesciences must provide the US Food and Drug Administration with a detailed action plan addressing specific violations of current good manufacturing practice at its injectables site in Vadodara, Gujarat.

“I’ve never launched a drug quite like this,” Sandoz’s CEO Richard Saynor has admitted frankly, as the firm spoke about its plans to launch GLP-1 assets in the future, starting with semaglutide in markets including Canada and Brazil as early as 2026.

Pointing to capacity constraints and an ever-increasing global demand, Aspen has trumpeted its prospects in GLP-1s after striking a deal that could have a significant impact for the firm, both commercially and from a manufacturing standpoint.

Fresenius Kabi has completed the divestment of its Chilean subsidiary Laboratorio Sanderson to Peru’s Medifarma, including the transfer of an IV drug facility in Santiago de Chile, as part of streamlining the German group’s manufacturing operations.

Does Zydus’ 50% stake acquisition in Sterling Biotech reflect a broader move of formulations companies to secure API supplies or acceleration of API segment restructuring begun by a couple of private equity (PE) funds?

With Sagent Pharmaceuticals operating in an increasingly competitive US injectables market, the company has recently been making moves to bolster its position in the wake of its separation last year from its former parent company, Japan’s Nichi Iko. Chief executive Vishy Chebrol talks to Generics Bulletin about the firm’s strategic goals.