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ANI Announces Launch of Sulfamethoxazole and Trimethoprim Oral Suspension USP 200 mg/40 mg per 5 mL


BAUDETTE, Minnesota (February 12, 2020) - ANI Pharmaceuticals, Inc. (“ANI”) (Nasdaq: ANIP) today announced the launch of Sulfamethoxazole and Trimethoprim Oral Suspension USP 200 mg/40 mg per 5 mL. The current annual market for this product is approximately $29 million, according to IQVIA. This launch represents ANI’s third generic product introduction in 2020.

Arthur S. Przybyl, ANI’s President and CEO commented, “This is the twelfth product that ANI has successfully launched from our library of discontinued NDAs and ANDAs. This library now includes 118 generic products, 52 of which can be launched via a CBE-30 or prior approval supplement filing. We continue to selectively re-commercialize products from this library that can provide economic value and, when possible, leverage our internal manufacturing capabilities.”

About Sulfamethoxazole and Trimethoprim Oral Suspension USP 200 mg/40 mg per 5 mL

Sulfamethoxazole and Trimethoprim Oral Suspension is indicated in the treatment and prevention of various infections proven or strongly suspected to be caused by susceptible bacteria which include urinary tract infections, acute otitis media, bronchitis, shigellosis, Pneumocystis jiroveci pneumonia, and traveler's diarrhea. For more information, including the complete list of indications and usages, please see the Full Prescribing Information.

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

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 therefor, 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; acquisitions; contract manufacturing arrangements; 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

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