Perrigo Company plc (Perrigo) operates as a pure-play self-care company. The company provides access to trusted self-care solutions that can be used without the need to visit a health practitioner for a prescription.
Perrigo's broad offerings are well diversified across several major product categories, as well as across geographies, primarily in North America and Europe, with no one product representing more than 5% of total revenue. In North America, Perrigo is the store brand private label p...
Perrigo Company plc (Perrigo) operates as a pure-play self-care company. The company provides access to trusted self-care solutions that can be used without the need to visit a health practitioner for a prescription.
Perrigo's broad offerings are well diversified across several major product categories, as well as across geographies, primarily in North America and Europe, with no one product representing more than 5% of total revenue. In North America, Perrigo is the store brand private label provider of self-care products in many categories, including upper respiratory, nutrition and women's health, along with brands, including Opill and Mederma. In Europe, the company’s portfolio consists primarily of brands, including Compeed, EllaOne, Solpadeine, and ACO.
Two key initiatives are fundamental to advancing the company’s self-care strategy — its Supply Chain Reinvention Program, a global supply chain efficiency program, and Project Energize, a global investment and efficiency program. In addition, the company continues to invest in other initiatives, including innovation, information systems and tools, and its people to drive consistent and sustainable results.
Strategy
The company’s strategy is to grow its business by responsibly leveraging its global infrastructure to deliver high quality self-care solutions to customers and consumers through its expansive product offerings, providing new innovative products, brands, and product line extensions to existing consumers and servicing new consumers through entering new adjacent products and categories, new geographies and new channels of distribution organically and inorganically.
Segments
The company operates through Consumer Self-Care Americas and Consumer Self-Care International segments.
Consumer Self-Care Americas (CSCA) comprises the company’s consumer self-care business in the U.S. and Canada.
Consumer Self-Care International (CSCI) comprises the company’s consumer self-care business outside of the U.S. and Canada, primarily in Europe and Australia.
Consumer Self-Care Americas
The CSCA segment develops, manufactures and markets the company’s leading self-care consumer solutions in the U.S. and Canada. The company primarily provides its customers self-care products that are sold and marketed under the customer's own brands and/or exclusive brands (store brands). The company additionally has a select lineup of branded self-care products. Customers include major global, national, and regional retail drug, supermarket, mass merchandise chains, e-commerce retailers, and major wholesalers.
The company’s store brand products are comparable in quality and effectiveness to national brands. Store brand products must meet the same stringent the U.S. Food and Drug Administration (FDA) requirements as national brands within the U.S. and the requirements of comparable regulatory bodies outside the U.S. In most instances, the company’s product packaging, marketing, advertising, and e-commerce focus are designed to invite and reinforce comparison to national brand products, while conveying a superior value for consumers.
Certain branded products are developed, manufactured and distributed within the CSCA segment. The company’s primary branded products sold under brand names include Compeed, Dr. Fresh, Firefly, Good Sense, Good Start, Mederma, Nasonex, Plackers, Prevacid24HR, REACH, Rembrandt, Steripod. In March 2024, the company launched Opill, the first ever FDA approved birth control pill for OTC use without age restriction. On September 26, 2024, the company announced a new brand partnership with Dr. Brown's Baby to provide infant formula solutions for babies with tolerance concerns. The new Good Start | Dr. Brown's portfolio will offer the same trusted infant formula products as the existing SoothePro and GentlePro, continue to feature probiotics, advanced protein hydrolysis, and 100% whey protein; but with a refreshed label to celebrate the new partnership.
Consumer Self-Care International
The CSCI segment comprises the company’s consumer self-care product categories outside the U.S. and Canada, including its branded products in Europe and Australia and its store brand products in the United Kingdom and parts of Europe and Asia. The company leverages its broad marketing, sales, regulatory, manufacturing and distribution infrastructure to drive market share, innovate new products and brands, in-license and expand product lines, and sell and distribute third-party brands. The CSCI segment products are sold primarily through an established pharmacy sales force to an extensive network of customers including pharmacies, wholesalers, drug and grocery store retailers, e-commerce retailers, and para-pharmacies in more than 31 countries, predominantly in Europe. Products in the CSCI segment are marketed using traditional and digital advertising as well as point-of-sale promotional spending to enhance brand equity.
While the company has hundreds of brands, it focuses its resources on growth brands, including Solpadeine, Coldrex, Physiomer, NiQuitin, ACO, Compeed, and ellaOne. The company’s new product pipeline is supported by internal R&D, new product development, acquisitions and partnerships, both in terms of brand extensions and product improvements.
Products
The company offers products in the following categories:
Upper Respiratory: Products that relieve upper respiratory symptoms, including cough suppressants, expectorants, sinus and allergy relief.
Nutrition: Infant formulas and nutritional beverages.
Digestive Health: Products such as antacids, anti-diarrheal, and anti-heartburn that relieve symptoms associated with digestive issues.
Pain and Sleep-Aids: Products comprised of pain relievers, fever reducers and sleep-aids.
Oral Care: Products used for oral care, including toothbrushes, toothbrush replacement heads, floss, flossers, whitening products and toothbrush covers.
Healthy Lifestyle: Products that help consumers live a healthy lifestyle such as smoking cessation, and well-being products.
Skin Care: Products for the face and body such as dermatological care, scar management, lice treatment, and other products for various skin conditions.
Women's Health: Women's health products, including feminine hygiene and contraceptives.
Vitamins, Minerals, and Supplements (VMS): Vitamins, minerals, and supplements.
Other: Rare Diseases Business and other miscellaneous self-care products.
In April 2022, the company completed the acquisition of HRA Pharma. HRA Pharma operating results are reported within both the company’s CSCA and CSCI segments.
New Products
The company considers a product to be new if it was reformulated into an additional unique product, was a product line extension due to changes in characteristics such as strength, flavor, or color, had a change in product status from prescription only (Rx) to OTC, (iv) was a new store brand or branded launch, was provided in a new dosage form or was sold to a new geographic area with different regulatory authorities, in all cases, within 12 months prior to the end of the period for which net sales are being measured. Notable new product launches in the year ended December 31, 2024 included Opill in CSCA Women's Health category and various CSCI line extensions in the Bronchostop cough brand in the Upper Respiratory category and ACO and Compeed bundles within the Skin Care category.
On March 4, 2024, the company announced that Opill began shipments to major retailers and pharmacies and was available on shelves nationwide and online later that month. Approved by the FDA for OTC use without age restriction in July 2023, Opill is the first-ever daily birth control pill available without a prescription in the U.S.
Each of the company’s product categories and growth brands have a three to five-year innovation master plan.
Significant Customers
Sales to Walmart Inc. represented 11.9% of the company’s consolidated net sales in 2024.
Competition
The company’s primary competitors include manufacturers, such as Dr. Reddy's Labs, LNK International, Inc., PL Developments, Aurobindo and Sun Pharmaceuticals, and brand-name pharmaceutical and consumer product companies, such as Haleon, Kenvue, Procter & Gamble, Reckitt Benckiser, Abbott Nutrition, Bayer AG, Opella, Philips, Teva, Viatris, and Stada.
Materials Sourcing
Historically, the company has been able to react effectively, yet not always immediately, to situations that require alternate sourcing. Should such alternate sourcing be necessary, FDA requirements placed on products approved through the Abbreviated New Drug Application (ANDA) or New Drug Application (NDA) process could substantially lengthen the approval of an alternate source and adversely affect financial results.
Government Regulations
The company is committed to consistently providing its customers with high quality products that adhere to FDA recommendations in industry guidance and meet the requirements of various regulations promulgated by the FDA. The FDA conducts periodic compliance inspections of the company’s facilities, quality management system and manufacturing processes. All of the company’s drug products are manufactured, tested, packaged, stored, and distributed according to current Good Manufacturing Practice (cGMP) regulations. Specific regulations and laws that impact the company’s business include, but are not limited to:
The Federal Food, Drug and Cosmetic Act, as amended (FDCA) gives authority to the FDA to oversee the safety of food, drugs, medical devices, cosmetics and other items. Following the 2012 enactment of the Food and Drug Administration Safety and Innovation Act, the FDCA incorporated, among other things, new user fee collection authority for prescription drugs. Since that time, user fee authority has been extended to OTC drugs, generic drugs and biosimilars and to additional supply chain parties.
The FDCA is regularly modified by Congress in other ways, including modifying FDA’s authority regarding drug and device shortages and enhancing the FDA's inspection authority of the drug supply chain.
The FDA Reauthorization Act of 2017 created a pathway by which the FDA may, at the request of an applicant, designate a drug with “inadequate generic competition” as a Competitive Generic Therapy.
Public Health Service Act, as amended (PHS Act) The Public Health Service Act (PHSA) regulates biologics through Section 351, which outlines the requirements for the approval, licensing, and oversight of biological products.
The company is subject to the Medical Device Amendments of 1976 to the FDCA and its subsequent amendments in the U.S. The regulations issued thereunder provide for regulation by the FDA of the design, manufacture and marketing of medical devices, including some of its products marketed under its oral care and OTC businesses. All of the company’s medical devices fall under Class I or Class II of the regulations. These devices are also subject to other general controls established by the FDA, such as registration, listing, labeling, and reporting obligations.
The company’s infant formula manufacturing sites in Vermont, Ohio and Wisconsin adhere to the standards of the U.S. Department of Agriculture (USDA) National Organic Program for production, handling, and processing to maintain the integrity of organic products and are certified and inspected by USDA-accredited certifiers, enabling them to produce and label organic products for U.S. and Canadian markets.
The company is subject to the requirements regarding List I chemicals. The company’s facilities that manufacture, distribute, import, or export any List 1 Chemicals must register annually with the DEA and are subject to inspection and enforcement action if determined to be out of compliance. The company must comply with a variety of U.S. laws related to doing business outside of the U.S., including but not limited to, Office of Foreign Asset Controls; United Nations and EU sanctions; the Iran Threat Reduction and Syria Human Rights Act of 2012; rules relating to the use of certain conflict minerals under Section 1502 of the Dodd-Frank Wall Street Reform and Consumer Protection Act; and regulations enforced by the U.S. Customs and Border Patrol.
The company is subject to various other federal, state, non-governmental, and local agency rules and regulations, including among others: U.S. federal anti-bribery laws; Federal Trade Commission regulation of advertising and marketing of consumer goods; consumer product safety requirements; state and federal privacy laws and regulations; laws requiring certain pharmaceutical manufacturers to track and report payments to physicians and teaching hospitals; and non-governmental standard-setting organizations, such as the International Organization for Standardization (ISO) and the United States Pharmacopoeia Convention, Inc. (USP).
History
Perrigo Company plc was founded in 1887. The company was incorporated under the laws of Ireland in 2013.