Pharmaceutical Equivalence


Drug products are considered pharmaceutically equivalent if they contain the same active ingredient(s), dosage form, route of  administration and identical in strength or concentration.

The Pharmaceutically equivalent drug products is formulated to contain the same amount of active ingredient in the same dosage form and to meet the same or compendial of other applicable standards (i.e., strength, quality, purity, and identity), but it may differ in characteristics such as shape, scoring configuration, packaging, excipients (including colors, flavors, preservatives), expiration time, and, within certain limits, labeling.

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