ANI Pharmaceuticals, Inc. (“ANI” or the “Company”) (Nasdaq: ANIP) today announced the approval of the United States Food and Drug Administration (FDA) and the launch of aminocaproic acid tablets USP, 500 mg. The current annual U.S. market for this product is approximately $ 12.7 million, according to IQVIA / IMS Health.

“This is ANI’s seventh generic product launch in 2020 and reaffirms our commitment to accelerate the pace of market introductions for our products. This important drug is one of the generics in the pipeline that we acquired from Amerigen Pharmaceuticals, Ltd. earlier this year. I congratulate our team on this achievement and look forward to the launch of other ANI products in the near future as we focus on realizing the full potential of our product portfolio, ”said Nikhil Lalwani, President and CEO of The direction.

About Aminocaproic Acid Tablets USP

Aminocaproic acid tablets are useful in improving hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be necessary. For more information, including a full list of indications and uses, please see the full prescribing information.

About ANI

ANI Pharmaceuticals, Inc. is an integrated specialty pharmaceutical company that develops, manufactures and markets branded and generic prescription pharmaceuticals. The product development areas targeted by the Company currently include narcotics, oncolytics (anticancer), hormones and steroids, as well as complex formulations involving sustained release and combination products. For more information, please visit our website www.anipharmaceuticals.com.

Forward-looking statements

To the extent that the statements made in this press release relate to information which is not historical, they are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, without limitation, those relating to the development, manufacture and marketing of the product and any additional product launches from the generic pipeline acquired from Amerigen Pharmaceuticals, Ltd. and other statements which are not historical in nature, particularly those which use terminology such as “anticipates”, “will”, “expects”, “plans”, “potential”, “future”, ” believes ”,“ intends to ”,“ continues ”, other words with similar meaning, derivations of these words and the use of future dates.

Uncertainties and risks may cause the Company’s actual results to differ materially from those expressed or implied by these forward-looking statements. Uncertainties and risks include, but are not limited to, the risk the Company may face in relation to the import of raw materials; competition from other products; acquisitions; contract manufacturing arrangements; delays or failure in obtaining approval of the product by the United States Food and Drug Administration; general commercial and economic conditions; market trends; product development; regulatory and other approvals and marketing.

More detailed information on these and other factors that could affect the actual results of the Company are described in the documents filed by the Company 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 documents filed with the SEC. All forward-looking statements contained in this press release speak only as of the date of this press release and are based on the current beliefs, assumptions and expectations of the Company. The Company assumes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20201217005232/en/

Contacts

Investor Relations:
Lisa M. Wilson, Site Communications, Inc.
Phone. : 212-452-2793
E: [email protected]

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