By Chris Wack


Biofrontera Inc. shares were up 31% to $4.84 in midday trading Wednesday after the company said the U.S. Food and Drug Administration has approved Biofrontera Pharma GmbH's cGMP laboratory in Leverkusen, Germany, as a contract laboratory for batch control and stability testing of Ameluz aminolevulinic acid hydrochloride gel, 10%.

The company said this recognition enables significant improvements in product manufacturing efficiency, quality control and reliability of supply.

The FDA cleared Biofrontera Pharma GmbH's laboratory to operate a method of impurity testing, which is a critical component of the gel's stability assurance. The clearance enables part of the necessary testing of production batches to be performed in the Leverkusen lab, reducing dependence on third-party suppliers and the risk of production downtime and product delays.

Previously, quality control was conducted entirely by contract manufacturers in collaboration with third-party providers.

Ameluz aminolevulinic acid hydrochloride gel is used to treat lesions.

The stock, which was paused several times Wednesday due to volatility, hit its 52-week low of $2.20 on March 8.


Write to Chris Wack at chris.wack@wsj.com


(END) Dow Jones Newswires

04-13-22 1232ET