Puerto Rico is one of the most important biopharmaceutical manufacturing centers in the world, with more than 50 years experience in pharmaceutical manufacturing and 30-plus years experience in sterile pharmaceutical manufacturing.
With 49 FDA-approved pharmaceutical plants scattered across the island, Puerto Rico is home to top multinational pharmaceutical companies, including Astra Zeneca, Abbott-AbbVie, Bristol-Meyers Squibb, Merck, Pfizer, Eli Lilly and numerous others. Many companies operate more than one site on the island.
Two-dozen different kinds of pharmaceutical products are manufactured in Puerto Rico: antihypertensive drugs, tranquilizers, laxatives, anti-diabetic drugs, vasodilators, antibiotics and contraceptives, among many others.
Puerto Rico’s Business Star Proposition relies on state-of-the-art infrastructure and a highly skilled workforce, which may explain why 12 of the world’s top 20 pharmaceutical companies have operations in Puerto Rico.
With five decades of pharmaceutical manufacturing under its belt, Puerto Rico has a highly experienced workforce knowledgeable in GMP, FDA and other global regulations. Although 60% of employees in the life sciences have at least a bachelor's degree, Puerto Rico offers the lowest labor costs of any region under U.S. jurisdiction – with hourly earnings in manufacturing averaging 65% to 80% of the U.S. average.
Developed as a result of extensive pharmaceutical research, workers' research and development (R&D) and clinical trials in both humans and animals. The originator relies on patents and other forms of intellectual property rights to justify the investment required to bring a product to market.
Duplicative copies of originator chemically synthesized drugs that contain the same active ingredient are identical in strength, dosage form, and route of administration. The prices of generic drugs are typically lower than the prices of originator drugs, particularly in the U.S. market where they are sold at a substantial discount from originator drug prices.
Distinguished from originator and generic drugs in that consumers do not need a prescription to purchase the drug. OTC drugs are considered by regulators to be safe for self-diagnosis and self-medication.
Medication, in dosage form, is composed of active pharmaceutical ingredients (APIs) and excipients. APIs are the ingredients that make drugs effective. Excipients are inert substances that give a medication its form, such as cornstarch (to make a tablet) or sterile water (to make a liquid) and serve as a delivery vehicle to transport the active ingredient to the site in the body where the drug is intended to exert its action.
Also known as follow-on biologics, these are versions of biological products that reference the originator product in applications submitted to a regulatory body.
The markets for biologics, over-the-counter (OTC) medicines, and generics show the most potential for growth and have become increasingly competitive. The OTC market growth will be driven by a growing aging population and a consumer trend to self-medication, as well as the the conversion of drugs from prescription to non-prescription. Product success is largely based on competition in product quality, safety and efficacy, and price. Puerto Rico has a favorable environment to compete in this changing industry.
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