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AMPH - Amphastar Pharmaceuticals Inc News Story

$18.68 0.6  3.5%

Last Trade - 07/05/21

Mid Cap
Market Cap £638.0m
Enterprise Value £628.8m
Revenue £250.4m
Position in Universe 2962nd / 6858

Amphastar Pharmaceuticals Receives FDA Approval for Dextrose Injection

Mon 29th March, 2021 11:00am
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RANCHO CUCAMONGA, Calif., March 29, 2021 (GLOBE NEWSWIRE) -- Amphastar
Pharmaceuticals, Inc. (NASDAQ: AMPH) announced that the U.S. Food and Drug
Administration (“FDA”) approved the Company’s Abbreviated New Drug
Application (“ANDA”) for Dextrose injection 50% in the 50 mL Luer-Jet(®)
Prefilled Syringe System. For the past 40 years, the company has sold and
marketed the product under the “grandfather” exception to the FDA’s
“Prescription Drug Wrap-Up” program. Net revenues for the Company’s
Dextrose injection for the year ended December 31, 2020, were $7.6 million.

Amphastar’s CEO and President, Dr. Jack Zhang, commented: “The FDA’s
approval of Dextrose, a product often on the Agency’s Drug Shortage list,
offers an opportunity to ensure quality products are produced at the highest
standard and highlights Amphastar’s manufacturing capabilities to fulfill
such market needs.”

Pipeline Information

The Company currently has five ANDAs on file with the FDA targeting products
with a market size of approximately $2.3 billion, three biosimilar products in
development targeting products with a market size of approximately $13
billion, and seven generic products in development targeting products with a
market size of approximately $10.5 billion. This market information is based
on IQVIA data for the 12 months ended December 31, 2020. The Company is
currently developing multiple proprietary products with injectable and
intranasal dosage forms.

Amphastar’s Chinese subsidiary, ANP, currently has 14 Drug Master Files, or
DMFs, on file with the FDA and is developing several additional DMFs.

Company Information

Amphastar is a bio-pharmaceutical company that focuses primarily on
developing, manufacturing, marketing, and selling technically-challenging
generic and proprietary injectable, inhalation, and intranasal products.
Additionally, the Company sells insulin API products. Most of the Company’s
finished products are used in hospital or urgent care clinical settings and
are primarily contracted and distributed through group purchasing
organizations and drug wholesalers. More information and resources are
available at

Amphastar’s logo and other trademarks or service marks of Amphastar,
including, but not limited to Amphastar(®), Primatene Mist(®),
Amphadase(®), and Cortrosyn(®), are the property of Amphastar.

Forward-Looking Statements

All statements in this press release and in the conference call referenced
above that are not historical are forward-looking statements, including, among
other things, statements relating to the Company’s expectations regarding
future financial performance, backlog, sales and marketing of its products,
market size and growth, product development, the timing of FDA filings or
approvals, including the DMFs of ANP, the timing of product launches,
acquisitions and other matters related to its pipeline of product candidates,
its share buyback program and other future events, such as the impact of the
COVID-19 pandemic and related responses of business and governments to the
pandemic on our operations and personnel, and on commercial activity and
demand across our business operations and results of operations. These
statements are not historical facts but rather are based on Amphastar’s
historical performance and its current expectations, estimates, and
projections regarding Amphastar’s business, operations, and other similar or
related factors. Words such as “may,” “might,” “will,”
“could,” “would,” “should,” “anticipate,” “predict,”
“potential,” “continue,” “expect,” “intend,” “plan,”
“project,” “believe,” “estimate,” and other similar or related
expressions are used to identify these forward-looking statements, although
not all forward-looking statements contain these words. You should not place
undue reliance on forward-looking statements because they involve known and
unknown risks, uncertainties, and assumptions that are difficult or impossible
to predict and, in some cases, beyond Amphastar’s control. Actual results
may differ materially from those in the forward-looking statements as a result
of a number of factors, including those described in Amphastar’s filings
with the Securities and Exchange Commission, including in the Annual Report on
Form 10-K for the year ended December 31, 2020, filed with the SEC on March
15, 2021. In particular, the extent of COVID-19’s impact on our business
will depend on several factors, including the severity, duration and extent of
the pandemic, as well as actions taken by governments, businesses, and
consumers in response to the pandemic, all of which continue to evolve and
remain uncertain at this time. You can locate these reports through the
Company’s website at and on the SEC’s website at The forward-looking statements in this release speak only as of
the date of the release. Amphastar undertakes no obligation to revise or
update information or any forward-looking statements in this press release or
the conference call referenced above to reflect events or circumstances in the
future, even if new information becomes available or if subsequent events
cause Amphastar’s expectations to change.

Contact Information:

Amphastar Pharmaceuticals, Inc.
Bill Peters
Chief Financial Officer
(909) 980-9484

GlobeNewswire, Inc. 2021
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