News Feature | August 6, 2014

FDA OKs Hovion API Plant Inspection

By Estel Grace Masangkay

The U.S. Food and Drug Administration (FDA) revealed the results of its inspection this month of the drug manufacturing and processing plants for international company Hovione.

Active Pharmaceutical Ingredient (API) development and manufacturing firm Hovione announced that its Irish plant had passed a pre-approval inspection by the U.S. Food and Drug Administration (FDA). The FDA conducted a 5 day inspection of the facility located in Cork, Ireland and found the site to be compliant with guidelines and principles of Good Manufacturing Practices (GMP).

Luisa Paulo, Hovione's Compliance Director, said, “The pre-approval inspection was triggered by a client NDA filing. It also covered the manufacturing of a commercial NDA and a generic antibiotic, doxycycline. It is an extremely satisfying result for our team and for our customers.”

So far this year, the FDA has been busy inspecting many other plants to ensure cGMP. Indeed, recently, the FDA also gave passing marks to another company’s inspection in May. WuXi’s facilities based in Shanghai, which are used as late and commercial stage analytical and stability testing facilities, achieved a passing rate in an FDA general GMP (Good Manufacturing Practice) inspection. WuXi’s facilities for clinical trial materials manufacturing, labeling, and packaging were also found to be in compliance with FDA standards.

The company stated, “This favorable FDA inspection outcome, in addition to last year’s MPA (EMA) approval, reflects our commitment to building operations with the highest standards of quality across our entire platform of R&D services.”

Earlier this year two other companies which have been previously in hot water over FDA inspections alerts have begun a comeback. Hospira announced that its North Carolina injectable-drug plant has been inspected by the FDA with no reported additional manufacturing issues. The FDA has lifted the plant’s status from official action indicated to voluntary action indicated in February.

Indian firm Ranbaxy previously faced serious strictures and import bans enforced by the FDA for quality and manufacturing issues at several of its sites. However its R&D facility in Gurgaon and its subsidiary’s clinical research center in Romania were inspected and cleared by the FDA in March. The firm was acquired by Sun Pharmaceutical a few days after the inspections’ results were released.

 

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