Extrovis AG and Dr. Reddy’s announce the launch of the authorized generic of CARAC (fluorouracil cream), 0.5% in the U.S.

Press Release

Extrovis AG and Dr. Reddy’s announce the launch of the authorized generic of CARAC (fluorouracil cream), 0.5% in the U.S.

Baar, Switzerland; August 14, 2025

Extrovis AG, a global pharmaceutical company focused on research-driven innovation, and Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced the launch of Fluorouracil Cream, 0.5%, an authorized generic and therapeutic equivalent of Carac® (fluorouracil cream) 0.5%, in the US market, approved by the U.S. Food and Drug Administration (USFDA).

Manufactured in Texas at one of Extrovis’ facilities, Dr. Reddy’s Fluorouracil Cream, 0.5%, is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.

“This product generic launch marks a key milestone in our commitment to increasing patient access and long-term value creation for the U.S. healthcare system. Our partnership with Dr. Reddy’s helps ensure that patients and healthcare providers in the United States have continued access to a high-quality and cost-effective product,” said Hans R. Kamma Co-CEO and Chief Strategy Officer of Extrovis AG.

“Dr. Reddy’s brings deep expertise in commercialization and distribution within the U.S. market,” added Raghavendra Rao PV, Chief Financial Officer of Extrovis AG. “This collaboration is aligned with our mission to strengthen pharmaceutical supply chains and serve public health needs responsibly.”

The partnership reinforces Extrovis’ strategy to extend the reach of its therapeutics while advancing long-term affordability and sustainability in healthcare.

Dr. Reddy’s Fluorouracil Cream, 0.5%, is supplied in a 30-gram tube for topical use only. Please click here to see the full prescribing information.

Carac® is a trademark of Extrovis AG

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About Dr. Reddy’s
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.

About Extrovis AG
Extrovis AG is a Switzerland-based global biopharmaceutical company committed to developing and commercializing high-quality therapies for unmet and under-addressed medical needs. With R&D and manufacturing operations in the USA, Italy, Hungary, and India, Extrovis delivers innovative, differentiated products across key therapeutic areas. Backed by strong R&D capabilities, regulatory expertise, and a robust global quality framework, the company advances its mission to improve patient outcomes and expand access to essential health care products worldwide. For more information, log on to: http://www.extrovis.com

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• CARAC (fluorouracil cream), 0.5%

CARAC (fluorouracil cream), 0.5%

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