LANNETT RECEIVES FDA APPROVAL TO MANUFACTURE NUMBRINO® AT SEYMOUR PLANT

Rhea-AI Summary

Lannett Company has received FDA approval to manufacture Numbrino, a topical anesthetic, at its Seymour, Indiana plant. This approval allows for a rapid expansion of liquid drug manufacturing previously done at its Carmel, New York facility, which was sold earlier this year. CEO Tim Crew emphasized the company's commitment to enhancing manufacturing efficiencies and indicated that production support from the Carmel site will now only be needed for less than 10 months, significantly faster than industry norms.

Positive

• FDA approval accelerates manufacturing capabilities for Numbrino.
• Enhanced manufacturing efficiencies anticipated at the Seymour plant.
• Shortened timeline for production support from 18 months to less than 10 months.

Negative

• None.

--Approval Allows Site to Rapidly Expand Liquid Drug Manufacturing--

PHILADELPHIA, Oct. 21, 2022 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it has received approval from the US Food and Drug Administration (FDA) to manufacture Numbrino^®, the company's branded topical anesthetic product, at its main plant in Seymour, Indiana. The company previously manufactured Numbrino and other liquid drug products at its Carmel, New York plant, which it sold in March of this year as part of a restructuring and cost reduction plan.

"We completed the liquid drug build-out at our Seymour plant and received this FDA approval well ahead of schedule, demonstrating our team's capabilities, dedication and focus," said Tim Crew, chief executive officer of Lannett. "Moreover, the approval indicates that we can continue transferring our liquid drug products with confidence, and it opens the door for expansion of our contract development and manufacturing efforts we market to other companies into the solution and suspension categories. We also expect our overall manufacturing efficiencies will be enhanced as production ramps up of Numbrino and other liquid and suspension drug products at the Seymour plant."

Crew noted that at the time of the sale of the Carmel plant the company said the buyer would support production of certain Lannett products for a period of up to 18 months. Now, our team will only need such production support for less than 10 months - a remarkably expeditious time frame by prevailing industry standards. 

About Lannett Company, Inc.:

Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company's website at www.lannett.com.

This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statement, including, but not limited to, achieving enhanced efficiencies related liquid drug manufacturing and contract manufacturing at its Seymour plant, successfully manufacturing Numbrino, and completing the transfer and production of other liquid drug products at the Seymour plant, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company's Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. These forward-looking statements represent the Company's judgment as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements.

Contact:
Robert Jaffe
Robert Jaffe Co., LLC
(424) 288-4098

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SOURCE Lannett Company, Inc.

FAQ

What is the significance of LCI receiving FDA approval for Numbrino?

The FDA approval allows Lannett to manufacture Numbrino at its Seymour plant, enhancing its liquid drug production capabilities.

When did Lannett receive FDA approval for Numbrino?

Lannett received FDA approval for Numbrino on October 21, 2022.

What is Numbrino used for?

Numbrino is a branded topical anesthetic used for localized anesthesia.

How does the FDA approval impact Lannett's manufacturing operations?

The approval enables rapid expansion of liquid drug manufacturing and improves overall efficiencies at the Seymour plant.