4 Requirements Imposed by FDA for Manufacturers of Generic Drugs


The Food and Drug Administration is a federal branch of the United States, which is responsible for the protection of public health. One of its primary responsibilities is to assure the public on the safety, efficacy, and security of every drug sold in the market—including generic ones.

Generic drugs are cheaper alternatives to branded drugs. They are especially helpful to people who are looking for budget-friendly medications. Unfortunately, a lot of consumers are hesitant to buy generic drugs because of the wrong connotations they have regarding its efficacy and safety.

As one of the providers of High-Quality Pharmaceutical Services in Old Bridge, New Jersey, WOODLANE PHARMACY gives light on this matter. The truth is that before drug manufacturers can mass produce and sell generic drugs to the public, they should first comply with the FDA’s requirements.

  • Meet the high standards imposed

    Contrary to what many people believe, generic drugs are as effective as its branded counterparts. As a matter of fact, the FDA requires every generic drug to have the same active ingredient as that of its brand-name version. By active ingredient, it means it is effective against the illness it is treating.

  • Similarity as to dosage, potency, quality, and label

    Aside from the active ingredient, the FDA also orders the manufacturers to produce generic drugs that have the same dosage, potency, quality, and label of their branded counterparts. Every year, the FDA conducts over three thousand inspections on manufacturing plants to make sure they comply with this regulation.

  • The capability of the manufacturers to produce generic drugs

    Before the FDA approves of the production of generic drugs, the manufacturers must first produce samples of the drugs they want to market. Apart from that, they are also mandated to write the necessary information about the manufacturing of the samples. Once this requirement is satisfied, the FDA will then proceed to review whether or not the manufacturers are able to make the generic drugs correctly.

    In addition, the FDA will also ask the manufacturers to prove that they are able to make the generic drugs consistently. They must explain and show to the FDA the procedures taken in coming up with the drugs. This covers how they intend to manufacture the drugs, what steps of the manufacturing process are taken, and what proof is available that each step will produce the same result each time.

  • Expiration of patents, exclusivities, and other legal rights

    The United States Patent and Trademark Office issues patents, exclusivities, and other legal rights to new brand-name drugs. These prohibit other drug manufacturers from producing and selling generic versions of the same drugs. The FDA must wait for the expiration of these legal rights before they can approve manufacturers to sell the generic versions of the new brand-name drugs.

Are you looking for a prescription pharmacy in Old Bridge, New Jersey that can help you with your medication budgeting? WOODLANE PHARMACY offers the lowest possible prices on all the medications we are selling.

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