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Taj Pharma (Full Manufacturing Process) Part-1
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1. What is a generic drug?
A generic drug is loosely defined as a “copy” of a brand name drug. The active ingredient or drug content is identical or “bioequivalent,” and works in the body the same way as the brand name drug. Such drugs must show that their active ingredients get to the bloodstream at the same time and to the same extent as the brand name version. Generics are similar to brand name drugs in several other ways. These include the quality of the product, how it’s absorbed in the body, the dosage form (meaning if it is a pill, inhaler, or liquid), safety, dose strength, the way it is administered (or in other words, whether it’s taken orally, injection, etc.), the way it performs (whether immediate or controlled release), and also the FDA-approved use. The U.S. Food and Drug Administration, or FDA, approves generics based on not only some, but ALL of these standards.
2. Are generic drugs as safe and effective as brand drugs?
Yes. Drug companies must prove to the FDA that the generic drug is either identical or otherwise bioequivalent to the brand drug, meaning they have the same quality, strength, purity and stability.
The FDA allows for small variations in flavor, color, packaging, and a few other parameters to account for variability during manufacturing. FDA limits how much variability is acceptable
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