BAUDETTE, Minn., July 27, 2015 /PRNewswire/ -- ANI
Pharmaceuticals, Inc. ("ANI") (NASDAQ: ANIP) today announced that
its ANDA collaboration partner Sofgen has received approval from
the U.S. Food and Drug Administration (FDA) of the Abbreviated New
Drug Application (ANDA) for Nimodipine 30mg Capsules. Trailing
twelve-month sales for the product are $25
million, according to IMS Health, with two current
competitors. ANI and Sofgen expect to begin shipping to
customers this year.
Arthur S. Przybyl, President and
CEO of ANI Pharmaceuticals stated, "This represents ANI's first
ANDA approval with our partner Sofgen. We are excited to have
achieved this milestone and look forward to a successful
launch."
About Nimodipine Capsules
Nimodipine is indicated for the improvement of neurological
outcome by reducing the incidence and severity of ischemic deficits
in patients with subarachnoid hemorrhage from ruptured intracranial
berry aneurysms regardless of their post-ictus neurological
condition (i.e. Hunt and Hess Grades I-V).
About ANI
ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an
integrated specialty pharmaceutical company developing,
manufacturing, and marketing branded and generic prescription
pharmaceuticals. The Company's targeted areas of product
development currently include narcotics, oncolytics (anti-cancers),
hormones and steroids, and complex formulations involving extended
release and combination products. For more information, please
visit our website www.anipharmaceuticals.com.
About Sofgen
Sofgen is a company established in Florida as a specialized developer and
manufacturer of niche pharmaceutical products with high barriers to
entry. Sofgen is part of the Procaps Group, who has a manufacturing
network with facilities throughout North and South America, and a wealth of experience in
soft capsules and related delivery technologies, servicing
customers within the health sector in 50 different countries around
the globe. For more information about Sofgen, please visit our web
site www.sofgenpharma.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, statements about price increases, the Company's future
operations, products financial position, operating results and
prospects , the Company's pipeline or potential markets therefore,
and 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, the risk that the Company may face with
respect to importing raw materials; increased competition; delays
or failure in obtaining product approval from the U.S. Food and
Drug Administration; general business and economic conditions;
market trends; products development; regulatory and other approvals
and marketing.
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,
including its most recent annual report on Form 10-K and quarterly
reports on Form 10-Q, as well as its proxy statement. 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.
For more information about ANI, please contact:
Investor Relations
IR@anipharmaceuticals.com
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SOURCE ANI Pharmaceuticals, Inc.