ANI Pharmaceuticals Announces the FDA Approval and Launch of L-Glutamine Oral Powder
July 15 2024 - 7:00AM
ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today
announced that following final approval from the U.S. Food and Drug
Administration (FDA) for its Abbreviated New Drug Application
(ANDA), the Company launched L-Glutamine Oral Powder. ANI’s
L-Glutamine Oral Powder is the generic version of the reference
listed drug (RLD) Endari®.
"The approval and launch of L-Glutamine Oral
Powder, the first AA-rated approved generic to Endari®, continues
to demonstrate the strong capabilities and execution of our R&D
team. We remain focused on ensuring that patients in need, and the
providers who care for them, have access to our high-quality
therapeutics,” stated Nikhil Lalwani, President and Chief Executive
Officer of ANI.
U.S. annual sales for L-Glutamine Oral Powder
total approximately $20.1 million, based on May 2024 moving annual
total (MAT) IQVIA data.
About ANI Pharmaceuticals,
Inc.
ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a
diversified biopharmaceutical company serving patients in need by
developing, manufacturing, and marketing high-quality branded and
generic prescription pharmaceutical products, including for
diseases with high unmet medical need. The Company is focused on
delivering sustainable growth by scaling up its Rare Disease
business through its lead asset Purified Cortrophin® Gel,
strengthening its Generics business with enhanced research and
development capabilities, delivering innovation in Established
Brands, and leveraging its U.S. based manufacturing footprint. For
more information, visit www.anipharmaceuticals.com.
Forward-Looking Statements
To the extent any statements made in this
release deal with information that is not historical, these are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such statements include,
but are not limited to, those relating to the commercialization and
potential sales of the product and any additional product launches
from the Company’s generic pipeline, other statements that are not
historical in nature, particularly those that utilize terminology
such as “anticipates,” “will,” “expects,” “plans,” “potential,”
“future,” “believes,” “intends,” “continue,” other words of similar
meaning, derivations of such words and the use of future dates.
Uncertainties and risks may cause the Company’s
actual results to be materially different than those expressed in
or implied by such forward-looking statements. Uncertainties and
risks include, but are not limited to: acquisitions and other
investments could disrupt our business and harm our financial
position and operating results; the limited number of suppliers for
our active pharmaceutical ingredients could result in lengthy
delays in production if we need to change suppliers; the risk that
the Company may face with respect to importing raw materials and
other ingredients and supplies necessary for manufacture of its
products from both domestic and overseas sources due to supply
chain disruptions or any other reason; delays or failure in
obtaining and maintaining product approval from the U.S. Food and
Drug Administration (“FDA”) of the products we sell; changes in
policy, guidelines or actions taken by the FDA and other regulatory
agencies, including drug recalls; the ability of the Company’s
manufacturing partners to meet our product demands and timelines;
acceptance of our products at levels that will allow us to achieve
profitability; the level of competition we face and the legal,
regulatory and/or legislative strategies employed by our
competitors to prevent or delay competition from generic
alternatives to branded products; the impact of legislative or
regulatory reform on the pricing for pharmaceuticals products;
issues with product quality, manufacturing or supply, or patient
safety issues; our ability to protect our intellectual property
rights; our ability to retain the services of our key executives
and other personnel; general business and economic conditions,
including the ongoing impact of and uncertainties regarding the
COVID-19 pandemic and inflationary pressures, as well as
geopolitical conditions, including but not limited to the conflict
between Russia and Ukraine, the conflict between Israel and Gaza,
or conflicts relating to attacks on cargo ships in the Red Sea.
More detailed information on these and
additional factors that could affect the Company’s actual results
are described in the Company’s filings with the Securities and
Exchange Commission (“SEC”), including its most recent annual
report on Form 10-K and quarterly reports on Form 10-Q, as well as
other filings with the SEC. All forward-looking statements in this
news release speak only as of the date of this news release and are
based on the Company’s current beliefs, assumptions, and
expectations. The Company undertakes no obligation to update or
revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
Investor Relations:Lisa M. Wilson, In-Site
Communications, Inc.T:
212-452-2793E: lwilson@insitecony.com
Source: ANI Pharmaceuticals, Inc.
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