Loperamide hydrochloride — Capsule (oral)

المنتج المرجعي للتكافؤ الحيوي · Loperamide hydrochloride

Molecule	Loperamide hydrochloride
Dosage form	Capsule (oral)
Reference comparator	Imodium (Janssen)
Tier	A
Recommended BE approach	In vivo bioequivalence (PK), or BCS-based biowaiver where eligible — ICH M13A / ICH M9

Illustrative harmonised register entry for the Arab markets. Confirm the definitive comparator with the authority of each market before use.
سجل استرشادي موحد · يلزم تأكيد المقارن النهائي من سلطة كل سوق قبل الاستخدام.

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Cite as: AUPAM Experts' Office, Loperamide hydrochloride (Capsule (oral)) — bioequivalence reference product — AUPAM Register, retrieved 2026-08-31, https://aupameo.org/datasets/register/loperamide-hydrochloride-s108.html