South America

Cipla has bolstered its ophthalmology portfolio and increased its global offering after chalking up an agreement to add Formosa Pharmaceuticals’ USFDA-approved clobetasol propionate 0.05% ophthalmic suspension.

Chinese biosimilars developer Bio-Thera is expanding its Latin American partnership with SteinCares with the addition of a third product.

Lupin has added two ADHD drugs to its Canadian portfolio, while also signing multiple branded deals in other global markets.

Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.

Generics Bulletin recaps the most recent regulatory news from across the world.

Regulators in Europe and the US have demonstrated a commitment to providing guidance that will make decentralized and point-of-care manufacturing a reality, the CSO of GermFree, a company that provides mobile and modular cleanrooms for manufacturing advanced therapies, tells the Pink Sheet.

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.

Brazil looks to EU, UK and others for inspiration on introducing a regulatory sandbox.

OTC private label/store brand product giant’s Q2 net sales down 10.7% to $1.1bn, but women’s health product sales jump 31.4% largely on Opill launched late in Q1. Biggest hit to results from infant formula business, down a reported 82% due to ongoing manufacturing quality-control remediation.

Following its recently announced leadership changes, Hyloris has made two announcements linked to the marketing of its combined pain therapy Maxigesic IV in Brazil and the US.