Injectable Ibuprofen Approved for Treating Pain & Fever

NASHVILLE, Tenn., Oct. 1 , 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX), a specialty pharmaceutical company, today announced that its ibuprofen injection product, has received regulatory approval in Mexico.

The approval follows Cumberland's partnership with PiSA Farmaceutica, which includes exclusive supply and distribution rights for the ibuprofen product in the Mexican market. PiSA is a well-established Mexican pharmaceutical firm with a leading injectable business in that country. Under the agreement, Cumberland is providing regulatory and manufacturing support, while PiSA led the regulatory process and will now launch the product in Mexico.

"We are thrilled to see our injectable ibuprofen product approved for use in Mexico," said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals. "This milestone underscores the growing global need for effective non-opioid pain management options and the strength of our collaboration with PiSA."

Cumberland has developed a proprietary formulation of ibuprofen for intravenous delivery to manage pain and reduce fever in the hospital and surgical settings. When administered prior to surgery, the product has been shown to significantly reduce post-operative pain and decrease the need for opioid medications, helping minimize their side effects.

"We are excited to introduce this novel formulation of ibuprofen to Mexico to help treat patients' pain in the hospital and surgical settings," said Felipe De Jesus Rios Mercado, Chief Commercial Officer at PiSA. "We believe in the product's potential and are confident it will be a strong addition to our market."

PiSA plans to introduce the product in 800 mg vials, making it accessible for a variety of clinical uses in Mexican healthcare facilities. With opioid misuse continuing to pose global challenges, the introduction of the injectable ibuprofen product aligns with broader efforts to support multimodal, opioid-sparing pain management strategies.

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes:

Acetadote^® (acetylcysteine) injection, for the treatment of acetaminophen poisoning;
Caldolor^® (ibuprofen) injection, for the treatment of pain and fever;
Kristalose^® (lactulose) oral, a prescription laxative, for the treatment of constipation;
Sancuso^®(granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;
Vaprisol^® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and
Vibativ^® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.

The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis.

For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, which can be found on the company's website www.cumberlandpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof.

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SOURCE Cumberland Pharmaceuticals Inc.

CUMBERLAND PHARMACEUTICALS ANNOUNCES PRODUCT APPROVAL IN MEXICO