In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|August 31, 2021
USAntibiotics Reopens Facility, Returning Antibiotic Production to the United States
Author(s)BioPharm International Editors
USAntibiotics will serve as the sole American-based provider of amoxicillin and amoxil clavulanate.
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USAntibiotics, the only licensed American manufacturer of penicillin-based amoxicillin and amoxil clavulanate, reopened a Bristol, Tenn. manufacturing facility on Aug. 30, 2021. The 360,000-ft2 facility had ceased operations last year until it was purchased by Jackson Healthcare, which restarted it under the new name of USAntibiotics.
When the facility is fully operational, it will be able to produce up to 300 million capsules and two billion tablets annually. The facility will be capable of manufacturing and storing a five-year supply of Amoxicillin, to supply the US strategic stockpile. According to the press release, amoxicillin accounts for 30% of all antibiotics prescribed in the US each year, for the country.
"As the first doses of USAntibiotics' life-saving drugs move down the assembly line, America will have declared its independence from Chinese antibiotics," said Rick Jackson, founder, CEO, and chairman of Jackson Healthcare, in a company press release. "Our mission is to solve our nation's reliance on foreign Amoxicillin and create a secure stockpile that will stand the test of time. Beginning today, the United States is back in the business of essential medicines."
According to Shane Jackson, president of Jackson Healthcare, there were numerous stories of dedicated people who worked without pay to keep the plant open while it was in the midst of bankruptcy.
"When we heard about the selflessness of these individuals, we knew that the company would be a perfect addition to the Jackson Healthcare family of companies," said Shane Jackson in the press release. "Their dedication to making the vital medications Americans need, even in the face of adversity, is inspiring and demonstrates their commitment to solving the supply-chain challenges long term."
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