Pharma's growing complexity needs spur AMRI aseptic investments

By Dan Stanton

- Last updated on GMT


Related tags Pharmacology Amri

AMRI has added a new line at a facility in Spain, effectively doubling its bulk aseptic API manufacturing capacity.

The multipurpose line is the result of an investment of over $10m (€8.4m) at the site in Valladoid, Spain, acquired by AMRI from Gadea Pharmaceutical Group for $174m in 2015​.

The expansion is the latest to support AMRI’s active pharmaceutical ingredient (API) global manufacturing footprint, and effectively more than doubles its bulk aseptic capacity.

“We now have four separate facilities within the AMRI network; two in France and now two in Spain,”​ George Svokos, chief commercial officer at AMRI told in-Pharmatechnologist.

“Capacity is a function of the mix of products; however, each of our four sites has the capacity to manufacture thousands of kilograms of sterile APIs with reactors ranging from 250L to 2,500L.”

Svokos told us the investment was driven by an increased demand for aseptic APIs.

“There are many parenteral products – existing and being approved – in the form of sterile suspensions and other such presentations that require the use of sterile API in their manufacturing. Certain ophthalmic products also require sterile APIs. This feeds well into our Drug Product business, which has capabilities in these types of sterile suspensions.”

He added the growing interest in biologics, controlled substances, and other complex compounds is further making the aseptic API space a lucrative opportunity for contract development and manufacturing organisations (CDMOs) like AMRI, which continues to grow its network in the space.

“Our intent is to remain a key player for complex and sterile API development and manufacturing, as well as sterile dosage form development and manufacturing,”​ he said, adding the expansion in Europe comes weeks after the firm announced the addition a new aseptic pre-filled syringe filling line at its Albuquerque, New Mexico site.

The firm is set to add capacity to manufacture roughly 50 million syringes per year from the facility – acquired for $110m from OsoBio in 2014​.

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