Manufacturing

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.

Sun Pharma discussed its Halol facility, generic Revlimid and the firm’s recent outright acquisition of Taro during its recent Q1 2025 financial earnings call.

Amid deals activity in India, Torrent Pharma executives spelt out their acquisition expectations and licensing strategy while an in-licensed Takeda brand did well in Q1 of FY25. The US growth trajectory is seen determined by five to ten product approvals expected this fiscal.

Sweden’s Xbrane Biopharma has delivered updates for two of its more long-term projects, including a proposed biosimilar to Bristol Myers Squibb’s Opdivo for which it is actively seeking a partner.

Manufacturers should keep a sharp eye on data from contract research organizations, looking for “any irregularities” amid a concerning trend of data integrity issues pertaining to BA/BE studies conducted by certain CROs in India, the director of the FDA’s drug center says.

Just-Evotec Biologics has announced an expansion of its partnership with Sandoz to develop and manufacture biosimilars.

Italy’s Olon Group has acquired French biotech contract development and manufacturing organization GTP Bioways, in a move that Olon says will allow it to “expand and diversify its technological offerings.”

While the European SPC manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.