Catalent and OSO expand ‘controlled substances’ businesses

By Gareth Macdonald

- Last updated on GMT

Related tags: Drug enforcement administration, Controlled substances act

Catalent and OSO BioPharmaceuticals Manufacturing have both announced expansions to their controlled substances businesses in the last week.

First up is New Jersey-based contract services firm Catalent, which has added a 3,000 sqft security cage with capacity for 500 storage locations for Schedule III-IV drugs at its unit in Philadelphia.

The firm has also expanded warehousing space at its facility in Schorndorf, Germany with 16 new pallets for the storage of controlled substances.

Frank Lis, VP of clinical supply services, told that: “Catalent sees this space as one of several growth areas in the coming years for our business.

Our expansion in the US will provide approximately three to four times our existing capacity for storage and distribution. Our expansion in Germany will increase total capacity by approximately eight fold.

He added that: “These are very significant expansions in capacity and will be an integral part of Catalent's growth in the coming fiscal year​.”

OSO Bio gets research OK from DEA

OSO BioPharmaceuticals Manufacturing, an Albuquerque-based contractor focused on biologics and injectables, has been granted ‘researcher registration’ by the Drug Enforcement Administration (DEA).

CEO Stuart Rose told this allows the firm to provide research, process and product development services for Schedule II-V controlled substances, creating a number of new business opportunities.

The significance [of researcher registration] is that we can now conduct preliminary work including, for example, formulation development and stability studies that allow us to develop the data needed for an FDA submission.”

Rose explained that although gaining ‘researcher registration’ was a complex and involved process the US controlled substance contracting sector is an attractive and underserved market.

There are a couple of CMOs that have DEA registrations, but most are much smaller than OsoBio… In general it is safe to say that there is much less competition in the controlled-substance space than there is in the less regulated space​.”

Many companies {CMOs] view the effort to meet specific DEA requirements – not just to obtain registration, but to also prevent diversion on an ongoing basis – as being too difficult to do​.”

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