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BAUDET, Minn.–(BUSINESS WIRE)–ANI Pharmaceuticals, Inc. (ANI or Company) (Nasdaq: ANIP) announced today that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for trimethoprim tablets USP, 100 mg.
ANI’s Trimethoprim tablets are the generic version of the Reference List Drug (RLD) of the same brand name. The current annual U.S. market for trimethoprim tablets is about $16.8 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.
“As we continue to focus on bringing limited competitive products to market, we are excited about the FDA approval and commercialization of Trimethoprim Tablets,” said Nikhil Lalwani, President and Chief Executive Officer, ANI.
About ANI
ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing and marketing high-quality branded and generic prescription pharmaceutical products, including those for diseases with unmet medical needs. Our team is focused on ensuring sustainable growth by building a successful refined Cortropin® Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our manufacturing capabilities in North America. For more information visit our website www.anipharmaceuticals.com.
Future announcements
To the extent that any statements in this release relate to non-historical information, 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, commercialization and potential product sales and the launch of any additional products from the Company’s overall pipeline, other statements that are not historical in nature, including, but not limited to, “anticipated,” “will,” “expected,” “plans” those using the terminology, “potential”, “future”, “believes”, “intend”, “continue” and other words of similar meaning, derivatives of such words and the use of future dates.
Uncertainties and risks could cause the Company’s actual results to differ materially from those expressed in such forward-looking statements. Uncertainties and risks include, but are not limited to, risks that the Company may face with respect to the importation of raw materials and other ingredients and materials necessary to manufacture our products; competition with other products; purchases; contract manufacturing mechanisms; delay or failure to obtain and maintain product approval from the US Food and Drug Administration; general business and economic conditions, including the ongoing impact and uncertainties of the COVID-19 pandemic and inflationary pressures; market trends; product development; regulatory and other approvals and marketing.
These and other factors that could affect the Company’s actual results are detailed 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 press release speak only as of the date of this 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.
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