Almost 8 in 10 prescriptions filled in the U.S. are for generic drugs. Generic drugs are chemically identical to branded drugs and must meet the same strict standards in order to receive approval from the Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Lower Price Does Not Mean Lower Quality.
Generic drugs cost substantially less than brand name drugs because the manufacturer isn’t required to repeat costly animal and clinical research on ingredients or dosage forms that are already FDA approved for safety and effectiveness.
Most people believe that if something costs more, it has to be better quality. In the case of generic drugs, this is not true. The standards for quality are exactly the same for brand name and generic products.
PHARMIA puts quality at the forefront of its operations. Healthcare professionals and consumers can be assured that our drugs meet the same standards as branded drugs. To receive FDA approval, a generic drug must:
- contain the same active ingredients as the branded drug
- be identical in strength, dosage form, and route of administration
- have the same use indications
- be bioequivalent
- meet the same batch requirements for identity, strength, purity, and quality
- be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for innovator products
Generic applicants are not required to repeat the extensive clinical trials that have already been used in the development of the original, brand-name drug since the safety and efficacy of the brand product has already been well established in clinical testing and many years of patient use. Instead, the generic applicant must scientifically demonstrate that its product performs in the same manner (bioequivalent) as the FDA-approved brand drug.
Generics may differ in shape, size or color, but they contain the same active ingredients as the brand. Because the generic is medically equivalent, it can be substituted for the brand product.
Generic medicines offer the same safety profiles as brand products. During the development and production processes, generics are required to follow the same rigorous standards of quality, safety and efficacy as brand products and these standards are closely monitored and enforced by the Food and Drug Administration (FDA) prior to and post product approval.
Production plants are regularly inspected to ensure that they are cGMP (current Good Manufacturing Practice) compliant and marketed products are regularly monitored to ensure continuous quality standards.
Additional information about generic drugs and the approval process in the U.S. is available on the FDA website at: www.fda.gov
Manufacturing, Packaging, and Distribution
Do you ever wonder where your medicine comes from? Who makes it? Where is it made and how is it distributed? Perhaps you’ve questioned, “How many hands does my product go through before it gets to me?”
At PHARMIA, we pledge to carefully oversee and manage all manufacturing, packaging, and distribution ourselves. We are one of the very few manufacturers of generic pharmaceuticals who can make this claim. We may use distributors and/or we may ship directly to the hospital or clinic. We will strive to take complexity out of the supply chain, which allows us to provide product to our customers and patients when they need it.
Research and Development – Super-generic Products
Super-generics and Biosimilars are the future. PHARMIA’s integration of generics and specialty R&D enables us to generate a robust pipeline of high-value, “value-added” medications, with an emphasis on complex compounds and/or complex formulations. PHARMIA’s knowhow and capabilities have expanded beyond tablets, capsules and patches. Our R&D team is working on the entire spectrum of pharmaceutical dosage forms including liquids, films, patches, implants, and injectables for a broad range of effective molecules including drugs, biologics, and gene therapy delivery systems. These are patented formulations and can’t be copied by others and thus, the margins will be higher than the simple generic and the “value-add” will improve patient compliance with their prescribed medicines.
PHARMIA is in the process of building a responsive, efficient, and caring customer service and sales support team that provides our customers with the service that they expect and we feel they deserve. We will strive to maintain one of the highest service levels in the industry and will establish customer relationships within retail chains, independent and institutional pharmacies, and wholesale distribution sectors. Our commitment to customer satisfaction is to be underscored by the devotion of our employees and guidance of our leadership team.