CUMBERLAND PHARMACEUTICALS ANNOUNCES PRODUCT APPROVAL IN MEXICO

Rhea-AI Summary

Cumberland Pharmaceuticals (NASDAQ: CPIX) has received regulatory approval for its injectable ibuprofen product in Mexico through a partnership with PiSA Farmaceutica. The product, designed for pain management and fever reduction in hospital and surgical settings, will be supplied in 800 mg vials.

Under the partnership agreement, Cumberland provides regulatory and manufacturing support, while PiSA led the regulatory process and will handle the product launch in Mexico. The injectable ibuprofen has demonstrated significant benefits in reducing post-operative pain and decreasing opioid medication requirements, supporting multimodal, opioid-sparing pain management strategies.

Positive

• Regulatory approval secured for injectable ibuprofen in Mexico, expanding international market presence
• Strategic partnership with PiSA Farmaceutica, a leading Mexican pharmaceutical company
• Product demonstrates effectiveness in reducing post-operative pain and opioid medication needs
• Addresses growing global demand for non-opioid pain management solutions

Negative

• Product success depends on PiSA's marketing and distribution capabilities in Mexico
• Faces potential competition from existing pain management solutions in Mexican market

Insights

Pharmaceutical Industry Analyst

Cumberland secures Mexican approval for injectable ibuprofen, expanding international reach through PiSA Farmaceutica partnership for hospital pain management.

Cumberland Pharmaceuticals has achieved a notable regulatory milestone with the approval of its injectable ibuprofen product in Mexico. This development represents a strategic geographic expansion for the Tennessee-based specialty pharmaceutical company through its partnership with PiSA Farmaceutica, an established Mexican pharmaceutical firm with a strong injectable business presence.

The approved product appears to be Cumberland's Caldolor® (based on portfolio information), a proprietary intravenous ibuprofen formulation targeting pain management and fever reduction in hospital and surgical settings. The clinical value proposition centers on its ability to significantly reduce post-operative pain while decreasing opioid requirements when administered pre-surgery. PiSA plans to introduce 800 mg vials across Mexican healthcare facilities.

This approval holds particular relevance in the current healthcare landscape where non-opioid pain management alternatives are increasingly prioritized. The product's positioning as part of multimodal, opioid-sparing pain management strategies aligns with global efforts to address opioid misuse concerns.

The partnership structure appears operationally efficient - Cumberland provides regulatory and manufacturing support while PiSA leverages its local expertise for regulatory navigation and market distribution. For Cumberland, this represents an asset-light approach to international commercialization, potentially creating a new revenue stream without significant capital investment in foreign infrastructure.

While financial terms and market size projections remain undisclosed, this approval establishes a foundation for Cumberland's international commercial presence beyond its established U.S. operations, diversifying its market exposure for its injectable non-opioid pain management product.

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.

FAQ

What product did Cumberland Pharmaceuticals (CPIX) get approved in Mexico?

Cumberland received approval for its injectable ibuprofen product, designed for pain management and fever reduction in hospital and surgical settings.

Who is Cumberland's partnership with for the Mexican market?

Cumberland partnered with PiSA Farmaceutica, a leading Mexican pharmaceutical company that will handle distribution and commercialization in Mexico.

What are the benefits of Cumberland's injectable ibuprofen product?

The product significantly reduces post-operative pain, decreases the need for opioid medications, and helps minimize opioid-related side effects when administered prior to surgery.

What dosage form will Cumberland's ibuprofen injection be available in Mexico?

The product will be available in 800 mg vials for use in Mexican healthcare facilities.

How does Cumberland's injectable ibuprofen address the opioid crisis?

The product supports multimodal, opioid-sparing pain management strategies by providing an effective non-opioid alternative for pain management in hospital and surgical settings.