Metformin hydrochloride — Tablet (IR, oral)

المنتج المرجعي للتكافؤ الحيوي · Metformin hydrochloride

Molecule	Metformin hydrochloride
Dosage form	Tablet (IR, oral)
Reference comparator	Glucophage (Merck/BMS)
Tier	A
Recommended BE approach	In vivo bioequivalence (PK), or BCS-based biowaiver where eligible — ICH M13A / ICH M9
Note	BCS III biowaiver may apply

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.

Other entries for Metformin hydrochloride

Prolonged-release tablet (oral)

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Cite as: AUPAM Experts' Office, Metformin hydrochloride (Tablet (IR, oral)) — bioequivalence reference product — AUPAM Register, retrieved 2026-08-31, https://aupameo.org/datasets/register/metformin-hydrochloride-s059.html