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Bio-Thera Solutions Gets Europe's Results on On-Site Inspection

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Bio-Thera Solutions (SHA:688177) received the results of the European Union's inspection of its Yonghe manufacturing facility, according to a Shanghai bourse filing on Monday.

The French National Agency for the Safety of Medicines and Health Products conducted an inspection on the site between Feb. 4 and Feb. 12.

The European Medicines Agency handed a GMP or good manufacturing practice certificate to the company after the factory's drug substance operations passed regulatory standards. However, the regulator found deficiencies in the deviation management measures for the finished formulation of the drugs.

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