Contract Manufacturing, Drug Substance, API

Mergers and acquisitions are positive for the CDMO industry, but there is a downside.

Additional reactor capacity and a wastewater processing plant increase API manufacturing capacity at the Cambrex site in Kalskoga, Sweden.

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.

Cambrex announces expansions of its North Carolina API pilot plant and Kalskoga, Sweden large-scale manufacturing facility.

Caladrius is selling the remaining percentage of the subsidiary in order to focus on cell therapy development.

Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.

Patheon adds API manufacturing capacity with acquisition of Roche’s Florence, SC facility.

Recipharm is investing more than EUR1.2 million to enhance its small-scale GMP API development and manufacturing capabilities in Paderno Dugnano, Italy.

Piramal Enterprises has entered into an agreement to acquire 100% stake in Ash Stevens all by cash for a consideration of $42.95 million plus an earn-out consideration capped at $10 million.

Bio/pharmaceutical contract service provides continue to invest in development, facility upgrades, technological advancement, and mergers and acquisitions.

Hovione will operate a commercial-scale continuous manufacturing facility in New Jersey as part of an agreement with Vertex Pharmaceuticals.

As specialty API outsourcing grows, manufacturers and contract development and manufacturing organizations are investing for the long haul.

Sustainable harvesting combined with CMO expertise helped Centroflora CMS ensure supply continuity after it acquired Boehringer Ingelheim's non-captive API phytochemicals portfolio.

Ash Stevens has received FDA’s approval to manufacture Takeda’s multiple myeloma drug, ixazomib, at its facility in Riverview, Michigan.

Operations at Catalent’s Beinheim, France, softgel facility were suspended following suspected deliberate action to misplace capsules.

Companies in the US will now have the opportunity to tap into Hermes Pharma’s technical expertise in effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules (ODGs).

Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.

Hovione will use Merrion's GIPET absorption-enhancing technology for solid-dosage drugs.

Industry experts share their views on the outsourcing model and the current and future direction of contract chemical API manufacturing.

External manufacturing plays a crucial role in pharmaceutical companies’ supply strategy. The author examines market trends for the captive and merchant global market for active pharmaceutical ingredients and intermediates.

Contract API manufacturers and fine-chemical producers roll out capacity and service expansions.

Expansion activity was limited as fine-chemical producers and CMOs of API and intermediates grapple with changing industry fundamentals.